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Jobs That Crossed My Desk Through April 6, 2014 Complimentary Service of Audreysnetwork.com

April 6, 2014

If interested in a listed position, contact the person whose information appears at the top of each listing. Individual listings of each executive search person are separated by string of stars. Multiple listings submitted by one recruiter are separated by straight lines. Remember I’m not a recruiter and only distribute this listing to help bioscience industry professionals identify potential positions with contact person information provided where possible. These positions originated with individuals in my network. Note that recently I’ve begun to receive many listings via Linked In and in such cases, I’ve listed company website if not person who sent listing to me. Jobs are materializing but with such a large pool of qualified professionals at this time, they fill up fast. Always be sure to check the website of recruiter or company to learn what jobs have popped up in between my publications. Unfortunately, I’m not able to post these every day but this tip should help you find newly posted jobs from the contacts sending the jobs below. Be sure to join the Bio2Device Group (includes professionals from all life science sectors and functions) to access their list of positions which includes different universe of jobs. You must attend one of B2DG meetings to become member but application in free. See details at www.bio2devicegroup.org. http://www.indeed.com/viewjob?jk=44580f31510cfe2a&from=api&q=(%22medical+device%22)+$80,000%2B&atk=18knolbak19ri6r9&sclk=1&sjdu=5Mmq1YSd2kR8hxoC94gIMsKRGHqEKcE12BbG_5-Xk0Sm9EOwYmbrxs5XX7lzZX0UMmiocuJAfMhVZRs5ncJVS-PmsKuioRxUq_k3dRLzn6Bn1YzwAUrS7lOviQP6QoT5b8y579oDxeyjBiYnTXJ6H33SqyE2stcy_Ubr763myX4 DIRECTOR, MCAP PROJECT MANAGEMENT Menlo Park, CA Acclarent, Inc., a member of the J&J Family of Companies is actively recruiting for a Director, MCAp Project Management to be located in Menlo Park, CA. Acclarent, Inc. is a medical device company in Menlo Park, CA that was established in June of 2004. The company is dedicated to the development of innovative devices providing new technologies to further meet the needs of ENT patients. Acclarent's initial focus is on achieving the goals of sinus surgery with novel, endoscopic, catheter-based tools - Balloon Sinuplasty™ devices. Through the Balloon Sinuplasty™ technology and our Relieva® product portfolio we offer ENT patients another option to conventional endoscopic sur ... ************************************************************************************ http://ch.tbe.taleo.net/CH06/ats/careers/requisition.jsp?org=PCYC&cws=1&rid=793&source=I Senior Vice President, Research Location: Sunnyvale, CA # of Openings: 1

Description Leads the scientific efforts of the company, overseeing developments as well as scientific partnerships for research and discovery with focuses on new targets and new molecules for clinical development. Manages the preclinical development programs, early clinical development and supports all phases of clinical development with nonclinical safety, clinical pharmacology, the manufacture of drug substance, drug product, and quality assurance. Responsible for the design and implementation of nonclinical Research and Development plans within budget and timelines. Develops scientific plans for differentiation of

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portfolio vs competition and identifies opportunities for drug combinations and optimized dosing schedules. Supports nonclinical development , drug substance development, drug product development and clinical pharmacology assessments for New Drug Applications. Member of the senior management team, reporting to the Chief of Oncology Operations & Alliances. Key Accountabilities/Core Job Responsibilities:

� Establish the company’s strategic research and development roadmap and activities in support of the portfolio strategy. � Oversee effective nonclinical research and development plans and implementation, includes oversight of basic research, medicinal chemistry, chemical development and manufacturing, clinical product development, clinical pharmacology/DMPK, analytical and bioanalytical chemistry, nonclinical safety and animal services. � Oversee nonclinical pharmacology, nonclinical pharmacokinetic, nonclinical safety, and clinical pharmacology sections for Investigational New Drug Applications (INDs) and New Drug Applications (NDAs) to the FDA, EMEA, and other health authorities around the world. � Represent Pharmacyclics as necessary to internal and external groups. Function or supervise others as an expert liaison between and leading academic specialists. � Lead the interface with clinical development for molecules likely directed toward Phase II and Phase III. � Accountable for building scientific capability and establishing clear success metrics. � Oversight of quality assurance functions for GMP, GLP, and GCP. � Oversight of central project management function, including the development of time lines, with specific milestones, goals and deliverables. � Maintain and develop a positive organizational culture, by promoting the values of the focus on patients, science, and our people. � Coach, manage and support employees to achieve business goals. Actively manage talent and career development. � Profile Pharmacyclics to the investment community as a leading clinical-phase biopharmaceutical company � Oversight and support of the basic research efforts in oncology and autoimmune diseases � Support medicinal chemistry efforts � Support maintenance of intellectual property estate

Qualifications:

� Demonstrated nonclinical research and development experience. Expert knowledge of FDA, EMEA, and ICH guidelines governing nonclinical development, drug manufacturing and controls. � Experience designing, building and leading a large scientific staff (comprised of direct and indirect reports) to support nonclinical research and development for early through late stage development molecules. � Proven record for advancing drug candidates into the clinic � Proven strategic thinking and sound judgment. � Experience building and leading teams in a start up environment. � Established publication record in peer review scientific journals.

Experience:

� Must have 20 years of experience in research and leadership roles within the pharmaceutical industry. � Postdoctoral fellowship experience preferred. � Must have 15 years managerial experience. � Must have experience working with experts with the areas of nonclinical and clinical drug development

Managerial Responsibilities:

� Directly manages assigned staff member recruitment and on-boarding

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� Oversees the work of direct reports to ensure on-time, on-target and within-budget results � Provides ongoing coaching, guidance and feedback to ensure direct reports are successful in their work, as well as have the necessary and timely access to information and other resources � Conducts regular one-on-one and any other staff meetings to ensure timely communication with direct reports � Provides formal performance reviews and career development planning for all direct reports � Complies with all company HR policies and procedures, as well as state/federal employment-related laws

Education Requirements (degree, certifications, etc.):

� Must possess a Ph.D and/or medical degree with strong background in biology and chemistry. � Board certification preferred. � Postdoctoral fellowship experience preferred.

Preferred Skills/Abilities

� Must be flexible and able to work well as part of a team but show clear leadership qualities � Must be able to delegate effectively � Must be able to communicate effectively to employees, officers, and directors of the company as well as to investors.

************************************************************************************************************************************** https://intuitive.taleo.net/careersection/2/jobdetail.ftl?job=42700&src=JB-10063

Job Description - Director, Enterprise Analytics (131305) Job Description Job : Finance Primary Location : United States-California-Santa Clara County-Sunnyvale Schedule : Full-time Director, Enterprise Analytics - 131305 Description Overview of Position: We are seeking candidates for a newly created Director of Enterprise Analytics. The position will report directly to the Vice President, Finance and Corporate Analytics and will work closely with executives, operating teams and technical personnel across the company to structure and use data to solve business problems. Ideal candidates will have a blend of operating and IT experiences as well as the ability to contribute as both a leader and an individual contributor. Roles and Responsibilities:

Work collaboratively with executives, operating teams and technical personnel across the company to identify and prioritize business questions that require data analysis to support decision-making;

Scope projects and build work plans to ensure: local systems/applications gather data needed for downstream analysis, data accuracy is validated (and fixed upstream in the local applications, if needed), data is extracted into a central analytic database, the architecture of the central analytic database is efficiently designed/maintained and aligned with ongoing changes to the local systems/applications, tools are built to access & analyze the data, projects are prioritized, the release schedule is managed and business analysts are able to answer key business questions;

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Own the central analytic database and related analytic tools, but not the local systems/applications where data is initially captured;

Maintain a working group to bring people together to raise awareness of data availability, provide statistical constructs, establish training curriculums and develop internal talent;

Work well with others to champion and align on vision, data and resourcing needs, budgets and roles of parties involved in enterprise analytic efforts;

Work closely with the team of data scientists responsible for creating analytic prototypes and completing ad-hoc analysis; the success of both teams will be enhanced by an effective working relationship of information sharing and supporting the other team’s objectives; and

Develop an organization that will initially consist of one direct report (a tool developer) and many indirect reporting relationships while we will find the optimal long-term balance between direct and indirect reports over the next 12 months.

Qualifications Skill/Job Requirements:

10+ years of experience in system and data management roles with 3+ years of experience managing company-wide data management/analysis projects;

Experience as either a direct consumer of the data or working very closely with the direct consumers of the data for enterprise analytic initiatives;

Hands on experience in leading, developing and implementing enterprise data architecture and complex data models for operational and data warehouse applications;

Executive presence and the ability to work well with all levels of an organization including technical and non-technical personnel;

Experience building a team of direct and indirect reports for the first time within a larger organization;

Ability to develop, communicate and gain organizational support for our enterprise analytics vision;

Hands-on experience of metadata management and master data management concepts, approaches and tools;

In depth knowledge of data integration concepts, approaches, and tools and the role of data architecture in successful implementation of data integration strategy;

Experience reviewing and assessing data architecture and database designs and then translating findings into actions to optimize the architecture and provide improvement recommendations;

In depth knowledge of physical database design and tuning using major relational database management systems (such as SQL Server, Oracle, Teradata, others);

Working knowledge of data modeling tools; Familiarity with client relationship management, SAP and a variety of business operations

applications is preferred; Excellent oral, written, and presentation communication skills; and Bachelor’s Degree in Computer Science, Computer Engineering or any related technology

field. **************************************************************************************************************************************** http://qmedcareercentral.devicespace.com/jobs/job-listing/director-sr-director-product-management-strategic-sourcing-330448?type=partner&source=Indeedorganic Director/Sr. Director Product Management & Strategic Sourcing InterMune, Inc. Location: Brisbane, CA

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Posted Date: 4/3/2014 Position Type: Full time Job Code: MOS 13082 Salary: Required Education: High school or equivalent Areas of Expertise Desired: Biotechnology,

Job Description Overview and Responsibilities: -Coordinate and manage plant and supply chain network management processes -Establish and ensure product-specific technical, quality and regulatory requirements are understood and met globally. -Monitor manufacturing process and supply chain network and performance -Develop and maintain Strategic Plans and Sales and Operation Planning processes -Manage full CMC product lifecycle management process. This would include periodically reviewing technical trends such as testing results, stability etc. -Manage CMO network to meet production and quality requirements in a cost effective manner. -Manage new packaging configuration changes -Partners with Legal to ensure our CMO contract negotiations are effective and consistent with InterMune business objectives. -Partners with Finance to ensure business processes are compliant with all local, national and corporate standards including SOX etc. -Partners with Product and Process Development to ensure successful new product introductions and technical transfers. -This is a managerial position that leads a team that includes CMO managers, a master planner and labeling manager. One of the CMO managers is based in Europe and has dotted line reporting to the Director of European Commercial Supply Chain. -This position will likely require up to 20% travel time. Requirements -BS/BA in technical field such as engineering, chemistry, biology plus 12-25 years within highly regulated Pharma or Biotech industry -Multi-disciplinary experience particularly across several of the following functional areas, Quality, Process Development, Manufacturing, Supply Chain, Project Management or Engineering, is required. -MBA or PhD or equivalent is desirable. -5 + years previous direct report management -Experience negotiating contracts for service providers

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-Experience with technical transfers -Experience developing Strategic Planning processes and improving business processes -German and/or French language skills are desirable. Please reference requisition MOS 13082 when applying for this position. InterMune is an Equal Opportunity Employer 8************************************************************************************************************************************ http://ch.tbe.taleo.net/CH06/ats/careers/requisition.jsp?org=PCYC&cws=1&rid=790&source=Indeed Description The Associate Director of Commercial IT and Operations reports directly to the Executive Director, IT and is responsible for planning and directing all aspects of the application and technical infrastructure to deliver on business priorities for the Commercial and Finance organizations including AX ERP system, Veeva System, Compliance and other related commercial software solutions. This individual must be an expert in running IT as a business delivering services and solutions to meet the needs of the organization The ideal candidate is an experienced IT leader familiar with developing the strategy and implementation plan to build the technical infrastructure required to accomplish the key goals of the Sales/Commercial CRM operations for a biopharmaceutical company in a high growth company. Key Accountabilities/Core Job Responsibilities: • Work with Executive Direct to align the IT Commercial Strategy with corporate vision and departmental business needs, especially for Commercial, Sales , Marketing and Finance. • Responsible for achieving stable operations of the AX ERP platform with timely response to support tickets, establishment of SLA’s, and ensuring a SOX compliance change management system. In addition, the individual needs to ensure that the service needs of the Finance , SCM, and other business units are met diligently. • Responsible for ensuring that the VEEVA platform meets the needs of the Field Sales, MSL’s and the enterprise as an effective CRM tool in enabling the core functional needs of these organizations. The individual needs to work effectively with Sales Operations, Field Sales and other IT groups to ensure that the system performs effectively. • Responsible for timely delivery of project initiatives achieved through experience-driven vision and planning skills and effective external vendor management. • Works collaboratively with IT and Commercial Organization to define metrics that drive strategies to achieve business objectives • Establishes and fosters relationships with business stakeholders and service providers • Works to continuously improve effectiveness, efficiency and customer satisfaction (internal and external customers) • Ensure corporate governance is included with business process via IT • Guide and assist in documentation of IT policy requirements • Ensure integration of commercial systems relative to CFR 21 Part 11, HIPPA, Sunshine Act and SOX adhere to outlined business requirements • Develop the IT Commercial and Operations team to maintain and modify commercial systems with the support of a 3rd party vendor as required; ensure team members are fully trained and understand the system dynamics and capabilities. • Develop, track, and control the IT Commercial annual operating and capital budgets. • Keep current with trends and issues in the IT industry, including current technologies and prices for Commercial, Sales, and Marketing. Advise, counsel, and educate executives and management on their competitive or financial impact. • Act as an advocate for the organization’s IT vision via regular written and in-person communications with the organization’s executives, department heads, and end users as it relates to Commercial IT • Coordinate and facilitate consultation with stakeholders to define business and systems requirements for new technology implementations. • Strong people management and coaching skills are a must

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Qualifications, Experience and Education Requirements (degree, certifications, etc.): • 12+ years of relevant industry experience, including 5+ years in a leadership role. • Required Biopharmaceutical company experience in fast-growing, commercial biopharma company; • Expert in managing the Commercial IT/data infrastructure • Successful track record of IT leadership, execution and delivery. Experience leading IT applications groups in applying innovative IT solutions in support of the business. • Management experience in Commercial IT , ERP systems . Experience with the following applications is a big plus: Salesforce.com/Veeva, Informatica, Mobile (ipad...), Reporting tools (Business Objects, Spotfire) • Proven experience in building out, training and leading an IT team; management experience with highly skilled IT individuals. • A thorough understanding of technologies required for corporate and cloud based networks. • The individual must be a self-driven, motivated senior IT leader with strong analytical and problem solving skills, and leadership/executive presence. • Can work very independently, collaboratively and possess the ability to interact and interface with all levels of management. • Strong communication skills (verbal and written); effective in interaction with executive management • Must be a self-starter and have excellent judgment and problem solving skills • Ability to multi-task in a fast-paced, dynamic environment • Bachelor's Degree or an equivalent level of education and experience. ********************************************************************************************************************************** https://abbvie.taleo.net/careersection/2/jobdetail.ftl?lang=en&job=35823&src=JB-13060 Job Description Assistant Director, Global Project Management-140000016U AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company formed in 2013 following sepfrom Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique apprinnovation to develop and market advanced therapies that address some of the world's most complex and diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 17countries. Description AbbVie Biotherapeutics (ABR) is AbbVie’s biotech business unit located in Redwood City, CA. The goal of ABdevelop innovative treatments for cancer. ABR currently has two programs in late stage development and sother programs in earlier phases. ABR employs approximately 125 individuals with a focus on Research anDevelopment. Its size and energetic work force allows for effective cross-functional collaboration, agility andecision making. We have an exciting opportunity for an Associate Director, Global Project Management repthe Director of Project Management in Redwood, CA. Key Responsibilities Include:

Manages the Project Team to create and implement project development plans, identifying project oand strategies with corresponding timelines and milestones. Leads multiple task forces, critical projinitiatives. Coaches team members to excel as a high-functioning team.

Interacts with Senior Management to develop therapeutic area strategies and interfaces with PTs to these to the project development plans.

Responsible for communicating project and program information to Senior Management. Responsibcompany communication on complex relationships.

Collects, compiles, and reports team progress and project information through various reporting sysincluding financial, staffing, milestone progress and goal completions. Develops project scenarios foranalysis and applies portfolio decisions to project plans.

Provides analysis of the impact of portfolio decisions on projects and communicates appropriately toProject Director (PD), senior management and executive management level.

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Sets PT agendas in coordination with Project Director, conducts PT meetings, and prepares meeting minuteManages PT members in the development and execution of the project development plan and governance bdeliverables. Conducts risks assessments and leads the PT in contingency planning.

Manages projects for external development partnerships/alliances and works with Partner PM as appropriate. May lead joint development meetings with external partners.

Trains / coaches / mentors team members and other functional areas in PM systems, procedures and tools. Manages early stage and late stage development program in coordination with PD and other stakeholders. Assist external partnership Joint Development Committee (JDC) Chair in planning, building agendas, and

managing JDC meetings. Analyzes the impact of portfolio decisions on projects, programs and Therapeutic Areas (TA’s). Assists in

developing and establishing strategies for annual portfolio review. Leads and designs contingency plans witassistance from team.

Assists management in the selection of action plans that best meets business objectives. Anticipates and leissue resolution at PT, PD and senior management levels.

Builds and manages overall project budget through close communication with the functional areas. Provides on a global basis, overall project timeline and cost estimates to assess project and licensing

opportunities impacting the therapeutic area. Equal Opportunity Employer Minorities/Women/Veterans/Disabled Qualifications Basic:

10+ years project management experience required, including management of large complex programs ancross-functional teams. 5-7 years of Drug Development/ Clinical Development/Safety experience preferred

Proven experience leading teams as a project manager. Basic knowledge of drug development and generally accepted project management practices, including bud

finance and portfolio review, and team management skills Team and drug development or project management related experience. Demonstrated leadership skills wi

broad business orientation. Preferred:

Advanced knowledge in project management practices, including budget, finance and portfolio review, drugdevelopment process and team management skills.

Experience in leading drug development projects, including externally partnered projects. Biologic oncology drug development experience. Master’s or PhD in a science or business related field. Position may be filled as Sr. Manager/Assistant Director level based on candidate's skills/experience.

Key Leadership Competencies:

Builds strong relationships with peers and cross functionally with partners outside of team to enable higherperformance

Learns, fast, grasps the 'essence' and can change the course quickly where indicated Raises the bar and is never satisfied with the status quo Creates a learning environment, open to suggestions and experimentation for improvement Embraces the ideas of others, nurtures innovation and manages innovation to reality

Significant Work Activities and Conditions Continuous standing for prolonged periods (more than 2 consecutive hoin an 8 hour day) Job Classification : Experienced Job : RESEARCH AND DEVELOPMENT Primary Location : USA-California-Redwood City Organization : GPRD-Pharma R&D Schedule : Full-time

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Shift: Day Travel : Yes, 10 % of the Time ************************************************************************************ Contact Details Website: https://home2.eease.adp.com/recruit/?id=11410002

Process Engineer-- Posted Wed, 03/26/2014 - 2:17pm by Lori.Perry Job Info Job Title: Process Engineer Company: Xoft (an iCAD company) Location: San Jose, CA Job Type: Full-Time Experience: 05-10 Years Status: Active Job Description Job Description:

The Process Engineer is responsible for evaluating existing processes and configuring manufacturing systems to reduce cost, improve sustainability and develop best practices within the production process.

RESPONSIBILITIES: • Evaluates manufacturing processes by applying knowledge of product design, fabrication, assembly, tooling and materials; conferring with equipment vendors; soliciting observations from operators • Maintains reliable and safe manufacturing systems while improving production rates, efficiencies, yields and costs. • Improves manufacturing efficiency by analyzing and planning work flow. • Assures product and process quality. • Keeps equipment operational by coordinating maintenance and repair services; following manufacturer's instructions and established maintenance procedures. • Prepares product and process reports by collecting, analyzing, and summarizing information. • Perform validation of software, equipment and processes. • Provides training and direction to the manufacturing operators. • Provides suggestions during incident investigations and advises on corrective action. • In conjunction with Document Control and QA, ensures accurate maintenance of DHRs, product structures and BOMs, specifications, procedures and drawings.

Experience Required:

REQUIREMENTS: • 5 – 7 years at a medical device company in an engineering or manufacturing environment

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• Experience with CAD, design of manufacturing test fixtures and general machine design. • Team player with excellent verbal and written communications skills. Must be able to interface effectively and professionally with colleagues as well as suppliers • General knowledge of GMP, ISO and MRP/ERP systems • Knowledge of validation protocols including IQ, OQ and PQ • Computer proficiency o CAD - SolidWorks o Proficiency in MS Word and Excel applications - required o Familiarity with Agile or equivalent document control systems - preferred o Basic programming knowledge – preferred

THE COMPANY: Based in San Jose, CA, Xoft, now an iCAD company, develops Electronic Brachytherapy (eBx) systems based upon miniaturized X-ray tube technology for the practice of radiation oncology in a broad range of clinical settings, eliminating the need for heavily shielded environments. The Axxent treatment platform provides a therapeutic dose of radiation directly to the region at risk with minimal radiation exposure to surrounding healthy tissue and without the logistics and costs associated with using radioactive isotopes. FDA-cleared for treatment of early stage breast cancer, skin cancer and endometrial cancer, the Axxent System is also cleared for use in the treatment of other cancers or conditions where radiation therapy is indicated including IORT. For more information please visit www.xoftinc.com.

Xoft’s technology is being received with great enthusiasm by radiation oncologists, breast surgeons and patients alike. This breakthrough technology will expand iCAD’s reach to a new and largely untapped market.

The parent company, iCAD, Inc., is known as an industry-leading provider of advanced image analysis and workflow solutions that enable healthcare professionals to better serve patients by identifying pathologies and pinpointing cancer earlier. With the recent acquisition of Xoft, Inc., an electronic brachytherapy systems company, iCAD has been transformed from a company focused on image analysis for the early detection of cancers to a broader player in the oncology market. iCAD believes that early detection in combination with earlier targeted intervention will provide patients and care providers with the best tools available to achieve better clinical outcomes.

COMPENSATION/ BENEFITS: iCAD offers a competitive salary, incentive stock options, and an exceptional benefits package including outstanding medical and dental insurance, vision care, short- term and long-term disability, group life insurance, a comprehensive 401(k) plan complete with company matching, section 125 flexible spending accounts for health and dependant care, tuition assistance, discounted homeowners and car insurance, pre-paid legal services, accident insurance, Digital Credit Union, and paid vacation & personal time off.

LOCATION: This position will work out of our San Jose, CA office.

Education Required:

• BS in Mechanical Engineering or equivalent experience

***************************************************** http://www-gene-com.careerliaison.com/careers/detail/00429903/Senior-Director-Vice-President-Global-Head-of-Real-World-Data-Science?_CL_SOURCE=16421658&jtsrc=www%2Eindeed%2Ecom&jtsrcid=1789&jtrfr=http%3A%2F%2Fwww%2Eindeed%2Ecom%2Fjobs%3Fq%3DDirector%26l%3DMenlo%2BPark%252C%2BCA%26start%3D6

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0&src=JB-12568 Senior Director/Vice President, Global Head of Real-World Data Science South San Francisco, California JOB ID: 00429903 Who We Are At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work. The Position The Real World Data (RWD) Science Head leads a multi-disciplinary teams of RWD Scientists, Specialists, and Analysts that provide expert advice and services to pre-approval and post-approval development and product portfolio programs across Roche. These services extend to RWD applications for Safety pharmacovigilence, Regulatory, Clinical, Operations, Global and Local Medical Affairs, and patient access program activities. The Head develops the strategic vision for the function, champions scientific rigor in RWD applications as Chair of the company’s RWD Leadership Network, and ensures the objectives, standards, deadlines and other requirements set by the business are achieved. The Head creates effective relationships with other functional leaders in PD, GMA, GPMA, and Local Medical Affiliates. Major Responsibilities and Accountabilities: Functional Leadership

Sets and implements the strategic vision of the RWD Science function Allocation of staff to project teams and to functional/cross-functional initiatives. Ensures alignment

of processes across Therapeutic Areas and projects as appropriate. This includes allocation of resources to scientist, speciatlist, and analyst roles, as well as investment in tools, processes and systems to deliver on commitments.

Actively contributes to the strategic direction within PD, GMA, and Biometrics, including participation on Biometrics Leadership Team

Ensures new and innovative data sources, quantitative techniques and methods are implemented as appropriate to business need.

Establishes and maintains relationships with key opinion leaders and talents, both outside and inside the company.

Oversight of adherence to department SOPs, standards and processes. Plans and controls the functional budget.

Review, or delegation of the review, of RWD components of PD, GMA, and GPMA strategies and deliverables.

Lead creation of tools enabling a broad range of company stakeholders to request/access RWD solutions to achieve their business objectives

People Development and Management Management and direction of activities of direct reports: setting of project, functional and individual

goals and objectives. Insures they align with the company strategy. Assessment of individual performance on an ongoing basis and at regular review sessions.

Inspires and motivates teams and department. Communicates a clear strategic vision with enthusiasm and a passion for success. Recruitment, training and development of staff. Facilitate the effective sharing of experiences and

knowledge within the department. Develops the talent pool, developing and managing succession planning. Effective at coaching and mentoring. Ensures effective allocation of teams to utilize their strengths and maximize input.

Who You Are

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Technical Requirements:

PhD in Epidemiology, Outcomes Research, Statistics, Biostatistics, Mathematics or similar areas of academic discipline.

Good knowledge of English in a business environment. Experienced managing quantitative scientists and analysts

Experience and/or Competencies Required:

Demonstrated managerial and leadership skills with professionals and non-professionals. Possesses excellent planning, organizational and analytic abilities, manages multiple tasks. Ability

to identify and resolve critical issues and to assess the impact of decisions. Communicates clearly and effectively in written reports, data presentations and meetings. Ability to consult and understand medical issues. Adept at explaining analytical basics to a broad range of stakeholders Actively establishes and maintains effective working relationships with other functions; is co-

operative, takes cultural and value differences into account in dealings with others. Good knowledge of international regulatory and ICH GCP guidelines. Courage to make decisions, enforce scientific rigor, and take calculated risks. Synthesizes detailed

information, and makes sound decisions based on risk assessment and balancing of priorities Thinks broadly, strategically, and timely when preventing, solving or managing problems, thinks

quickly under pressure. Shows high level of initiative and business awareness Highly flexible with a systematic and goal-oriented working style Takes responsibility and accountability for global function Other: Mobile yes

************************************************************************************ https://abbvie.taleo.net/careersection/2/jobdetail.ftl?lang=en&job=35823&src=JB-13060 Job Description Assistant Director, Global Project Management-140000016U AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company formed in 2013 following sepfrom Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique apprinnovation to develop and market advanced therapies that address some of the world's most complex and diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 17countries. Description AbbVie Biotherapeutics (ABR) is AbbVie’s biotech business unit located in Redwood City, CA. The goal of ABdevelop innovative treatments for cancer. ABR currently has two programs in late stage development and sother programs in earlier phases. ABR employs approximately 125 individuals with a focus on Research anDevelopment. Its size and energetic work force allows for effective cross-functional collaboration, agility andecision making. We have an exciting opportunity for an Associate Director, Global Project Management repthe Director of Project Management in Redwood, CA. Key Responsibilities Include:

Manages the Project Team to create and implement project development plans, identifying project oand strategies with corresponding timelines and milestones. Leads multiple task forces, critical projinitiatives. Coaches team members to excel as a high-functioning team.

Interacts with Senior Management to develop therapeutic area strategies and interfaces with PTs to these to the project development plans.

Responsible for communicating project and program information to Senior Management. Responsibcompany communication on complex relationships.

Collects, compiles, and reports team progress and project information through various reporting sysincluding financial, staffing, milestone progress and goal completions. Develops project scenarios foranalysis and applies portfolio decisions to project plans.

Provides analysis of the impact of portfolio decisions on projects and communicates appropriately to

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Project Director (PD), senior management and executive management level. Sets PT agendas in coordination with Project Director, conducts PT meetings, and prepares meeting minute

Manages PT members in the development and execution of the project development plan and governance bdeliverables. Conducts risks assessments and leads the PT in contingency planning.

Manages projects for external development partnerships/alliances and works with Partner PM as appropriate. May lead joint development meetings with external partners.

Trains / coaches / mentors team members and other functional areas in PM systems, procedures and tools. Manages early stage and late stage development program in coordination with PD and other stakeholders. Assist external partnership Joint Development Committee (JDC) Chair in planning, building agendas, and

managing JDC meetings. Analyzes the impact of portfolio decisions on projects, programs and Therapeutic Areas (TA’s). Assists in

developing and establishing strategies for annual portfolio review. Leads and designs contingency plans witassistance from team.

Assists management in the selection of action plans that best meets business objectives. Anticipates and leissue resolution at PT, PD and senior management levels.

Builds and manages overall project budget through close communication with the functional areas. Provides on a global basis, overall project timeline and cost estimates to assess project and licensing

opportunities impacting the therapeutic area. Equal Opportunity Employer Minorities/Women/Veterans/Disabled Qualifications Basic:

10+ years project management experience required, including management of large complex programs ancross-functional teams. 5-7 years of Drug Development/ Clinical Development/Safety experience preferred

Proven experience leading teams as a project manager. Basic knowledge of drug development and generally accepted project management practices, including bud

finance and portfolio review, and team management skills Team and drug development or project management related experience. Demonstrated leadership skills wi

broad business orientation. Preferred:

Advanced knowledge in project management practices, including budget, finance and portfolio review, drugdevelopment process and team management skills.

Experience in leading drug development projects, including externally partnered projects. Biologic oncology drug development experience. Master’s or PhD in a science or business related field. Position may be filled as Sr. Manager/Assistant Director level based on candidate's skills/experience.

Key Leadership Competencies:

Builds strong relationships with peers and cross functionally with partners outside of team to enable higherperformance

Learns, fast, grasps the 'essence' and can change the course quickly where indicated Raises the bar and is never satisfied with the status quo Creates a learning environment, open to suggestions and experimentation for improvement Embraces the ideas of others, nurtures innovation and manages innovation to reality

Significant Work Activities and Conditions Continuous standing for prolonged periods (more than 2 consecutive hoin an 8 hour day) Job Classification : Experienced Job : RESEARCH AND DEVELOPMENT Primary Location : USA-California-Redwood City Organization : GPRD-Pharma R&D Schedule

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: Full-time Shift: Day Travel : Yes, 10 % of the Time ************************************************************************************ http://www.indeed.com/viewjob?jk=59486e1d2b4e9d5f&from=api&q=(%22medical+device%22)+$80,000%2B&atk=18knp53j719s20gi&sclk=1&sjdu=3TEPkymJaenhOmJQRNbwmS_kee17kRXpdrjRlrAQTINNhH9ONEgNoaj8pxZLwsCwX1krMj9BrCp0eSPFXmxuRHrSBtC9etvCGJ9l9Ft_rOzgV8BQ2QB7WovvCFAdv4rlsOOjdw9XON1NY5uz9HAWBbtOxbkpwBJ73NxDmKoriQuXY_mNX_mqAmhpCdUGgnUWpWX7ZSTP7BI25MpAOeEi8A Sr. Regulatory Affairs Analyst/Manager Sterling Life Sciences - San Francisco, CA Partial Job Description 1) Create regulatory strategy for new products 2) Manage filing related activities 3) Provide regulatory expertise on daily issues and interface with outside regulatory agencies 4) Manage assigned product registration activities, including filing determinations, 510ks, technical files and international product registrations 5) Compile information from multiple sources for submissions, guiding the project teams in creating documentation for submissions, writing summaries and other required documentation for submissions 6) Prepare annual licensing renewal, product registration and listings 7) Establish quality system related procedures and policies for regulatory affairs and update as necessary 8) Provide guidance in complying with regulations 9) Assist in developing rationale and documentation for new product development, product changes, testing, design review, labeling changes, packaging changes, material changes, etc. 10) Review and approve product labeling and promotional materials in accordance with global regulations 11) Represent regulatory affairs on project teams 12) Attend product project teams meetings, as required and provide regulatory guidance and review 13) Review and approve document change orders 14) Assist the product safety team with making product safety determinations 15) Conduct Medical Device Reporting (MDR), vigilance activities, product corrections and removals in a timely manner 16) Develop regulatory strategies, templates and documentation for product registrations for each new or modified product 17) Interface with FDA on regulatory issues and international regulatory agencies

4/6/2014 15

18) Assist management in planning regulatory activities 19) Identify road blocks, strategizing on various regulatory paths for new products 20) Work with Quality, Engineering, and Marketing to ensure product supply 21) Interface with customs officials to resolve product holds More questions? Want to know the Salary range? Keep reading. The best way to get more details is to click ‘Apply’, upload your resume, and ENTER YOUR QUESTIONS in the ‘Cover Letter’ field. A recruiter will call you and answer all of your questions (if they feel you are a fit for the role). Your resume will be kept CONFIDENTIAL – we respect your privacy. Our Recruiters are more likely to respond to your questions if they know you are *seriously* interested, and prefer to know a little bit about your background before calling. Tips: 1) Follow our CEO on Twitter for status-updates about your job application: http://www.twitter.com/sterlinghoffman 2) Add our CEO on Facebook: www.facebook.com/angel.mehta99 We will try to respond to your questions privately via Twitter or Facebook only. ************************************************************************************ http://www.indeed.com/viewjob?jk=93062e2daaa5c715&from=api&q=(%22medical+device%22)+$80,000%2B&atk=18knp09mo19t20qb&sclk=1&sjdu=3TEPkymJaenhOmJQRNbwmS_kee17kRXpdrjRlrAQTIOQjLPVXP72UEsk6D2PtOXjiUXqBqDoosDpg0frF_PQWvvZHzaeY0d4_6Q1cVajpoi2IUkRMtjdxcELHAl-E_rLsOOjdw9XON1NY5uz9HAWBbtOxbkpwBJ73NxDmKoriQu3ow2boNabZ7r-RFxlhqFfa6jcYwaxtS4InVQrA9m-mQ Sr Dir Global Mktg Covidien - Santa Clara, CA Are you Covidien? Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. We deliver outstanding results and innovative solutions in the Medical Device and Medical Supplies segments. Through progressive thinking and cutting-edge technologies, Covidien is well positioned to lead the way in today's rapidly changing healthcare industry. Whatever your specialty or ambitions, you can make a difference at Covidien – both in the lives of others and your career. About Covidien Surgical Solutions – GI Solutions Covidien GI solutions (formerly BÂRRX Medical, Inc.) is located in Sunnyvale, California. GI Solutions has developed a Radiofrequency bipolar ablation technology that treats Barrett's esophagus as well as other gastrointestinal diseases like GAVE and Radiation Proctitis. The company has a direct sales organization in the US and independent distributors outside the US. At GI Solutions we are committed to the ongoing research and treatment of Barrett's esophagus in order to improve the quality of life of patients diagnosed with the disease. At Covidien, we strive to fully understand our marketplace, customers, communities and employees, and we enter into relationships with a sense of honesty, fairness and trust. We are an affirmative action/equal opportunity employer. Position Summary Manage all Product Management, New Product Development and New Business Development activities for GI Solutions. Additionally manage the company's Customer Service Department and Business Analytics function. Lead product managment team and provide strategic direction and input relative to product development, product management, sales, and operations. Responsible for developing market models

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and strategic plans for the various markets in which the company currently competes or may consider entering . Principal Accountabilities Responsible for hiring and developing the Product Management, Customer Service and Business Analytics teams for the Company. Provides current product line forecasting and planning input and new product launch forecasts to the operations department. Strong leadership skills to enable and provide overall strategic direction and leadership to operations, sales, R&D and Regulatory. Defines and provides direction for the new product development activities Assesses new market opportunities and possible product distribution alliances to include assessing market size and defining product requirements. Thoroughly understands the current HALO product lines and their clinical utility Manage product line pricing analysis, strategy and tactical implementation Develop the strategy and plans for RFA Users Conferences KOL (Key Opinion Leader) Development – inclusive of Sunnyvale Office Visits for KOLs Oversee Markets Analysis - Barrett's, Gave, RP, Squamous, and lead research into Cervical, AIN, Airway, and Biliary Strategic Initiatives: Develop strategy for Kaiser Penetration, ASCs, + possible GSA contracting Requirements College DegreeRequired, MBA preferred Emphasis in Life Sciences, Medicine, or related, technical field ideal desirable Eight years experience within Medical Device marketing, inclusive of Product Development and Business Development functions Had formal marketing and/ or business development experience from a larger company and recent experience with startup companies Successfully launched new products Managed and built marketing departments for a minimum of 3 years Strong written and oral communication skills. Strong computer skills with specific skills in all Microsoft Office software (can develop spreadsheets, forecasts, presentations etc) Ability to establish and maintain good working relationships with all functional areas Direct sales experience strongly desired Ability to multi-task and work independently Able to work with a sense of urgency and pace consistent with a start up JobsRadar.com - 8 hours ago - save job - block ************************************************************************************ http://www.indeed.com/viewjob?cmp=Creganna--Tactx-Medical&t=Extrusion+Engineer&jk=a7a5130c2756f3fc&sjdu=QwrRXKrqZ3CNX5W-O9jEvcVXwGEOxGn5g76fdspb6R0ib8EBPNyI-3RlBqK9qmA9xzmr0bg_XLfDAucCVfazLw Extrusion Engineer Creganna-Tactx Medical - Campbell, CA Creganna-Tactx Medical is leading supplier of products, technologies and services to medical device manufacturers worldwide. The company is ranked among the Top 10 medical device outsourcing companies in the world and serves over 400 customers in 30 countries. We are respected partners to the industry’s leading brands for Minimally Invasive therapies and command a market leadership position in key segments. A lifesaving medical device containing our technology is used every 1.2 seconds. Working in a fast-paced environment, we are defined by a shared set of values – to be reliable, honest, flexible and innovative in everything we do. Our company story is about growth and our team is the backbone of our success. The shared stories of our people are about development opportunities in this growth environment and about the millions of people around the world that lead healthier lives because of our life’s work. SUMMARY: The primary role of the extrusion engineer is to develop and grow extrusion capability at Creganna-Tactx Campbell facility. In addition to the technology development the candidate will identify the requirements/skills for engineering and production personal. The successful candidate will work with the commercial team in terms of winning new business and will be required to support technically. The extrusion engineer will support braiding and balloons development teams and knowledge of these areas will be an important additional skill. RESPONSIBILITIES:

Working with stakeholders, provide technical leadership, develop and set milestones and objectives for the technology transfer and future development.

Investigate materials, process, tooling and equipment in order to best meet current and future customer needs.

Identify extrusion operations process improvements that can improve our business position.

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(e.g. Quality improvement, cost reduction, capability enhancement etc.) Drive project improvement activities using data driven methodologies, statistical techniques

and lean manufacturing tools to achieve targets. Project and customer relationship management. Assist in identifying root cause analysis and determining corrective action. Execute corrective

actions from concept through document change to training and implementation. Assist in contract review of sales orders to review for feasibility and capacity. Communicate lead times, capability and capacity restraints to cross functional departments. Responsible for Health & Safety within assigned areas to include accident investigation and

corrective action. Manage operational activites of direct reports including scheduling and personnel issues Execute quoting for new projects. Any other duties assigned from time to time.

REQUIREMENTS: Bachelor's degree in either chemical engineering, polymer science, materials engineering, or

mechanical engineering; advanced degree preferred. 8+ years’ experience in Class II or Class III extruded medical tubing, with experience that

includes the design, fabrication, assembly and validation of equipment used to manufacture these devices.

Working knowledge of current materials used in manufacture of extruded medical devices, including PVC, fluoropolymers, thermoplastic elastomers, and compounding of thermoplastic elastomers.

Strong analytical and problem solving skills. Project management and Validation and Process Development experience. Strong people management skills. Excellent written and communication skills.

************************************************************************************ https://gilead.apply2jobs.com/ProfExt/index.cfm?fuseaction=mExternal.showJob&RID=16578&CurrentPage=29 Gilead Job Title: US HCV Marketing Launch Team - Promotions Requisition Number: 16578 Country: US State: California City: Foster City Location: Foster City Functional Area: SALES/MARKETING Position Type: Regular Full-Time / Part-Time: Full-Time Shift: Days Specific Responsibilities: The Promotions Role on the HCV Marketing Launch Team reports to

the Director of HCV Marketing - Promotions and will be responsible for developing promotional initiatives for the US HCV launch.

Essential Duties and Job Functions: Duties will include but not be limited to: Job Responsibilities • Develops and leads key elements of the brand strategic and tactical launch plan to key HCP groups • Defines operational plan for delivering against marketing launch strategy and drives implementation by engaging external agencies, internal cross-functional partners. Regularly measures the success of initiatives.

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• Implements product promotional communication strategy for physician promotions ensuring alignment with the overall brand strategy • Gains approval for marketing materials through internal review process including management reviews and Med-Legal-Reg. Secures final production. • Works cross-functionally with Sales, Legal, Regulatory, Medical and other key internal stakeholders. • Analyzes complex brand opportunities and provides logical recommendations; leads any required action planning. • Provides tactical and strategic input on key planning teams such as: conventions, sales meetings. • Ensures that all marketing activities are in compliance with regulatory and legal requirements. • Manages marketing budget and project timelines. • May run advisory boards in conjunction with medical department. • Establishes strong working relationships with local and national level Key Opinion Leaders.

Knowledge, Experience and Skills: • 5+ years of experience. • Bachelor’s degree in marketing or related fields. • Track record of successful pharma/biotech marketing • Experience with Medical-Legal-Regulatory guidelines and cross-functional committee reviews. • Experience with marketing strategy, sales and regulatory policies and practices. • Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of marketing materials. • Strategic thinker with ability to formulate, develop and execute development strategy. • Ability to conduct analysis and use complex analytical tools. • Demonstrated excellence in project management and effectively managing multiple projects/priorities. • Strong verbal, written, and interpersonal communications skills and ability to efficiently and productively communicate to a variety of groups and audiences. • In-depth ability to conceive, develop and implement multi-dimensional marketing and business plans. • Strong presence with ability to command respect through exercise of sound business judgment and clear decision-making. • Experience leading cross-functional teams. • Ability to successfully work with external agencies, including advertising, public relations and medical education vendors to develop programs and materials. • Demonstrated ability to manage budgets, with an understanding of expense budget planning and tracking. Preferred: • MBA or other advanced business degree. • Therapeutic Area knowledge. • Previous pharmaceutical sales experience. • Experience managing direct reports.

***********************************************************************

Jobs That Crossed My Desk Through March 30, 2014 ****************************************************************************** Newest Jobs at JGB BioPharma Consulting- Week of 3/31/14

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To apply for a position send your resume to Jobs@JGBBioPharma.com QA Technical Writer – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) PG127A DESCRIPTION: Description: Responsible for researching, writing and editing CMC related reports, summarizing data from process development studies for submissions to the FDA and for publication and/or presentation. Will also assist in the development of formats and guidelines for CMC documentation. Remains informed of the latest professional, technological, and regulatory developments in CMC writing. Closely work with process chemists to evaluate organize data and write summary reports. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods and techniques. May acts as a writing liaison to other teams. Assists with the planning for document development. Creates tables, graphs, and flowcharts. Develops documents that are written according to approved style guidelines and adheres to a high standard of accuracy. Ensures that reports adhere to standard format, terminology, and style. May review the work of others and assist in managing the flow of work. Assists in identifying process improvements and in building the CMC writing infrastructure. Responsibilities Support the preparation and review of the annual product review report function for US and EU. Oversee the preparation of the management reviews reports as assigned Support quality performance metrics and significant quality events to Sr. Management Review technical and/ or approval of technical reports, including, but not limited to drug

development and process controls, technology transfer, stability, process validation. Support quality during or supplier regulatory inspections Writing or approving standard operating procedures, policies, specifications, and regulatory

submissions or other controlled documents Participate in other quality improvement and risk management projects as assigned Document control support Other duties as assigned EXPERIENCE AND QUALIFICATIONS: An ability to create effective presentations from raw data is essential. An ability to interpret experimental data is essential. Must have ability to work well with others in high-pressure situations. Must have demonstrated problem solving abilities. Strong organizational skills are required. Strong written and verbal communication skills are required. A basic understanding of Process Development, CGMP, and regulatory affairs is required. Must have experience writing CMC sections of regulatory submission documents and sections. Good computer skills are required. In depth working knowledge of MS word, Excel, PowerPoint is a must. A minimum of 5 years of reports writing experience is required. A minimum of 2 year’s experience in a pharmaceutical, biotech, or CRO technical writing position is

required. A minimum of a Bachelor’s degree in Chemistry or related discipline is required. Equivalent experience may be accepted. QA Expert (Principal Quality Representative) – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) F127JN DESCRIPTION: Responsible to represent QA at a GMP manufacturing site and for the review and approval of

production and quality documents and records, including but not limited to, master batch records, executed batch records, deviations, CAPAs, procedures, change controls, component and drug substance/drug product specifications.

4/6/2014 20

Interacts with manufacturing Quality and Production operations staff and management to provide real time GMP manufacturing guidance and decisions for critical drug product manufacturing operations.

Provide QA person-in-the-plant support of GMP drug product manufacturing, performing real-time batch record review and production oversight as required

Provide accurate and timely final drug product and drug substance lot dispositions Review and approve pharmaceutical manufacturing and testing deviations and investigations and

deliver associated deviation/CAPA tracking, follow-up, and effectiveness assessment Review and approve GMP documents and specifications Collect data, analyze, and report on contract manufacturing trends for Annual Product Review or

Management Review Identify and propose quality and manufacturing process and system improvements Attend on site meetings with contract manufacturing teams to represent quality and/ or cGMP

regulatory needs EXPERIENCE AND QUALIFICATIONS: Ability to maintain diplomatic and productive business environment at all levels Ability to work independently Experience writing pharmaceutical quality deviations Min. 15 years’ experience in cGMP pharmaceutical quality assurance or manufacturing Superior attention to documentation and record detail Ability to prioritize and balance efforts between major and minor issues Understanding of the drug development process, pharmaceutical quality systems, drug release

testing, stability, and equipment maintenance and process validation Understanding of ICH Good Manufacturing Practices regulation concepts Prefer Bachelor’s degree or higher in science, engineering, pharmaceutical sciences, or chemistry Associate Manager / Manager, Regulatory Affairs – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) OT127Z DESCRIPTION: Responsible for supporting regulatory activities, will write and prepare IND/NDA documents,

contribute to the completion of projects, assist with development programs, and ensure compliance with required FDA regulations.

Write and prepare regulatory documents for submission to the FDA (specifically for INDs and NDAs).

Review technical documentation. Assist with development programs. Maintain regulatory records, including archive of submissions and FDA correspondences files. Maintain up-to-date regulatory knowledge, including regulatory procedures and changes. Responsible for making sure submissions comply with applicable regulations and guidance

documents. Track submissions and ensure timely filing of documents. Liaison with other internal departments regarding documentation and submissions. Manage project deliverables and timelines. Conduct or participate in meetings with internal teams and government agencies. Distribute agendas, take minutes and assign/follow up on action items. Ensures all assignments are completed within defined timelines and meet regulatory and other

company guidelines. Other duties as assigned. EXPERIENCE AND QUALIFICATIONS: Direct IND and NDA submission experience required. Intermediate understanding and utilization of regulations and guidances. Experience with pharmaceutical drugs is required; small molecules a plus. Ability to work independently.

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Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners.

Must be flexible when priorities change and have the ability to complete tasks with a sense of urgency.

Excellent written and verbal communication skills. Must be able to work successfully within a team. 4-year degree in Biological Sciences, Chemistry or Engineering required. Experience: 3-5+ years of direct, recent experience in Regulatory Affairs. Associate Director QC Team Lead – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) A131AF DESCRIPTION: Plans, controls and directs QC testing operations for all product dosage forms. Oversees/manages facility/equipment utilization relative to compliance of current manufacturing

processes/procedures with current Good Manufacturing Practices, health, safety and environmental policies and other federal regulations, and company policies and procedures.

Oversight of commercial stability programs, including activities conducted at third parties, to ensure compliance with policies.

Plans, organizes and directs the activities of all QC product testing functional areas, to assure that the materials released from the laboratories comply with internal and regulatory requirements, and that agreed upon target dates for work are met.

Oversight of third party laboratory operations to ensure compliance with policies. Establishes and maintains proper compliance with cGMPs, as well as corporate/departmental SOPs

(cGMP and safety); included are review of procedures to assure complete and accurate testing records, adherence to SOPs, lab failure investigations and reporting procedures.

Establishes QC product testing departmental objectives, establishes long-term strategy and resources requirements, and periodically reviews progress toward reaching goals, with ultimate responsibility for meeting those objectives.

Approves specifications/control procedures for all products and components; approves operations and QC validation protocols and reports (analytical, cleaning, process computer).

Helps create department and corporate quality-related policies and procedures. Establishes and fosters a positive continuous improvement mentality leading to the implementation

of best industry practices. Interacts with the FDA, trade associations, and professional groups Represents QA/QC on key cross-functional product and/or process teams and special corporate

task forces. Serves on all key quality-related corporate committee including recall, NORMS and GMP. Ensures that all Product Testing associates have the appropriate education, experience and training

(cGMP, safety, technical) to effectively, efficiently and safely complete their responsibilities. Assist the Head of Quality to establish operating and capital budgets; manages operating expense

budget. Manage deviation and OOS process and assist in resolution. Performs other duties as may be required or necessary. On time delivery of analytical results Laboratory compliance – deviations and audit observations QC Productivity On time completion of stability Customer service level QC compliance with training requirements EXPERIENCE AND QUALIFICATIONS: Experience leading a GMP commercial lab operation Thorough knowledge of analytical principles, methodologies, and techniques utilized in the

pharmaceutical QC environment. Thorough knowledge of operational functions of production, packaging, technology/MPS, materials

management.

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Thorough understanding of budgeting principles, resource management, and goals/objective setting and implementation.

Auditing and technical report writing experience. Expert knowledge and understanding of GMPs, keeping up to date with current industry issues and

changing regulations. Experience in Deviation Management and batch disposition. Experience in Change Control, validation and APR/PQR. Experience with health authorities audits. Proven experience with Lean, 5S, Opex, IQP applied principles Very good user knowledge for Microsoft Word and Excel, SAP and Trackwise. Excellent oral and written communication skills required. Demonstrate leadership ability and excellent interpersonal skills. Ability to work under minimal direction, independently or as part of a team if necessary. A minimum of 10 years of related pharmaceutical experience. A minimum of 8 years of managerial experience in a QA/QC organization. Bachelors degree in a scientific discipline is required. Advanced degree is preferred. Equivalent experience may be accepted. Clinical Program Manager – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) B94RP DESCRIPTION: Accountable for successfully overseeing program level execution of all clinical operations

deliverables, and leads the clinical program team to meet program goals and objectives. Assists in the planning and execution of clinical projects while adhering to budget, scope and

schedule requirements Responsible for the execution of a suite of clinical trials from protocol design to the final clinical

study report Creates and maintains clinical program timelines for study start-up, maintenance and close-out Attend clinical meetings and inform members of relevant clinical program updates Ensure study timelines are met, and study progress is tracked and reported Work with the clinical scientist and medical monitor to develop protocols and all documents

required to initiate and conduct clinical studies (includes informed consent forms, investigator brochures, case report forms, etc.)

Oversee performance of CROs and/and or regional CRAs to ensure compliance to the protocol and regulations, including attending site visits, co-monitoring and review of IMV reports

Select and manage vendors required to conduct clinical studies (includes overseeing contracts, payments, and deliverables to ensure quality of service provided)

Select study investigators and evaluate adequacy to perform research and meet study timelines Develop, implement, and manage project-level clinical budgets and timelines (includes

communicating initial strategies and changes to project team as appropriate) Develop, implement, and manage monitoring plans (may include some site visits to manage site

and vendor relationships and to ensure quality of data/services) Oversee study drug supply and ensure the project team is updated on all new developments or

changes in supply needs Identify project risks and proactively create and implement mitigation strategies Collaborate effectively with cross-functional management teams and external partners Communicate with management to ensure adequate resources are assigned to achieve program

deliverables Mentor CRAs and other operational personnel May manage direct reports (contract, term &/or FTE) Coordinate and participate in investigator meetings EXPERIENCE AND QUALIFICATIONS: Thorough knowledge of personal computers and MS Office Suite. Knowledge of GCP and ICH guidelines required. Bachelor's degree in a relevant scientific discipline or equivalent.

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8+ years of independent clinical trial management experience (including vendor management) as a CRA in the pharmaceutical industry and additionally 0-2 years of experience as a clinical project manager responsible for the implementation of multiple concurrent clinical trials.

Scientist – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) SP111K DESCRIPTION: The successful candidate will be involved with enzyme inhibitor testing, new enzyme assay

development and kinetic characterization of small molecules as inhibitors of a family of related enzymes.

Additional duties may include recombinant enzyme purification by chromatographic methods, protein characterization for purity and identity, and possibly also bioanalysis by immunochemical or HPLC-UV/MS.

Experience with biochem, protein biochemistry, purification, chromatography, and enzyme kinetic assays

Experience with enzymology, kinetics, chromatography, and bioanalysis EXPERIENCE AND QUALIFICATIONS: Highly self-motivated Strong organizational skills Excellent oral and written communication skills Ph.D. in the field of enzymology or related area, preferably with experience in redox related

enzymes, as well as postdoctoral or industrial experience involving enzyme characterization ********************************************************************************************** Apply at https://www.theladders.com/job/jobboard?cr=6151855&pl=ind-16 Medical Device CCI - San Diego, CA Leading Medical company is seeking a successful sales representative to call on hospitals in the assigned area. Hiring Company Industry: Medical Devices & Diagnostics Number of Employees: 10,000+ Employees Total Compensation: $115K to $145K - Base Salary: $60K - $70K - Bonus / Commission: $55K - $75K - Other: $100K to $1000K Reports to: RSM Location: San Diego, CA 4 year degree with a strong GPA 2 years of medical device exp.- urology, rehab or wound care a +++ (Prior b2b exp. with a leading co is preferred IKON, ADP, etc) Documentation of sales success (presidents club, trip winner etc) No more than three jobs post grad. Ability to close new business and maintain the base of business. Successful candidate will be responsible for calling on local hospitals selling a variety of medical devices. (Cold calling, contract implementation and in-servicing)

4/6/2014 24

Hiring company is the market leader and provides a fast tract to mgt. TheLadders.com - 24 days ago - save job - block ************************************************************************************ https://www.smartrecruiters.com/CurexoTechnologies/76044458-technical-scientific-writer Technical/Medical Writer Curexo Technologies - Fremont, CA Job Description The scientific technical writer develops, writes, and edits material for customer manuals, release notes, submissions, clinical documentation, web content, sale collaterals and internal procedures as required. The writer must be able to effectively “translate” highly technical information into end-user appropriate language without sacrificing technical accuracy. The writer will utilize functional specifications, access medical equipment, and interface with engineers, surgeons and others as applicable to develop content. The technical writer ensures documents meet the company’s high standards for technical and regulatory accuracy, clarity, tone, and style while adhering to aggressive timelines. The writer must also be an experienced project manager, able to represent their area on cross functional teams while managing multiple writing projects simultaneously. Travel Requirements: ≤ 10% Training opportunities and/or medical sites. Job Responsibilities:

Compose medical reports, presentations and other comprehensive materials using correct grammar, punctuation, spelling editing, formatting, and proofreading skills to clearly and concisely provide accurate information.

Maintain Product User Manuals. Assist in writing summaries for regulatory submissions, engineering and clinical reports. Maintain web content and sales collaterals.

Qualifications

A life science degree is absolutely essential. Minimum five (5) years experience within the medical device industry writing/editing

scientific/medical material. Adobe CS version 5 or 6 prefer. Excellent oral/written communication, research, and interpersonal skills required. Strong engineering acumen with the ability to read and decipher specs, blue prints, and other

technical documents to create end-user friendly procedures. Excellent project management skills, including participation on cross functional teams Detail-oriented, including the ability to follow directions precisely. Excellent organizational, analytical, and problem solving skills. Must also be able to work independently on a multiple task work load and produce a quality

product under a tight time constraint. Highly proficient with MS Office, Webworks, RoboHelp desirable.

Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards. Attendance and Punctuality are essential function of the position.

************************************************************************************ Apply at http://www.indeed.com/viewjob?cmp=Harmin-Services&t=Program+Manager&jk=78edfeee206ef7fe&sjdu=QwrRXKrqZ3CNX5W-O9jEvboqH3KsCi-ZpW0p65RLM2UtLWqCxv1Rfa3S0to3fB6wUHM9QZ5lk1CbJGyP6dTZIxcAZ9MNzT2qcG-8qgh6JFE Program Manager - Pharmaceutical Harmin Services - Thousand Oaks, CA Job Details: Responsible for support of large programs, creates appropriate documentation, including but not limited to: agendas, minutes, and capturing accomplishments. Develops supporting documentation and monitors timeliness and scheduled resources for projects, develops & reports on project metrics,

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project planning & scheduling, collation and alignment of status reports, ensures compliance with practices, policies, procedures, goals of project sponsors and approved methodologies.; Skills: ; experience running large scale projects and portfolios of projects, excellent understanding of program and project management processes and procedures, methodologies, best practices ; strong MS Project, Word, Visio, PowerPoint, and Excel skills ; understanding of systems for sharing and collaboration Device and Quality background and Pharmaceutical industry experience is a plus Excellent communication skills and executive presence Highly detail oriented with good strategy development abilities 8 – 12 years Program Management experience Planning and managing several workstreams within the Quality and Engineering function – Manage a cross-functional team and work flows Able to navigate complex political environments Sharepoint experience Education: Bachelor’s degree is required Experience: 8/12 years of experience in Project/program management within the medical device industry and with a strong quality background. This person will have experience planning and managing several workstreams within the Quality and Engineering function, and managing a cross-functional team and work flows. Sharepoint experience is required. ************************************************************************************http://www.indeed.com/viewjob?jk=36a7364b5d0e92cb&from=api&q=(%22medical+device%22)+$80,000%2B&atk=18k4o2liv19vh31u&sclk=1&sjdu=5Mmq1YSd2kR8hxoC94gIMsKRGHqEKcE12BbG_5-Xk0Sm9EOwYmbrxs5XX7lzZX0Ur2tzD1SahZdyuo2HaCWNjyj-Oh9uuVQRfJXarVnhivpn1YzwAUrS7lOviQP6QoT5b8y579oDxeyjBiYnTXJ6H33SqyE2stcy_Ubr763myX4 Sales Operations Manager Irvine, CA Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. We deliver outstanding results and innovative solutions in the Medical Device and Medical Supplies segments. Through progressive thinking and cutting-edge technologies, Covidien is well positioned to lead the way in today’s rapidly changing healthcare industry. Whatever your specialty or ambitions, you can make a difference at Covidien – both in the lives of others and your career. At Covidien, we strive to fully understand our marketplace, customers, communities and employees, and we enter i ... ************************************************************************************ https://jobs.smartbrief.com/action/listing?listingid=68FE0147-F7E0-4B69-8928-AF39262A5759&briefid=3e572e18-3fbc-11d5-ad13-000244141872&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0&utm_source=brief

Job Summary Date Posted: 3/14/14 Location: Foster City, CA Counsel II, Legal (Anti-corruption) Gilead Sciences Inc Job Description Specific Responsibilities: This position will report to the director of Gilead’s anti-corruption program within Commercial Legal. The individual will help implement an effective cross functional anti-corruption program at Gilead Sciences. The individual will help develop and carry out policies and procedures; provide business conduct and compliance support to Gilead’s Access Operations and Emerging Markets (Gilead’s program to increase access to medicines and healthcare in low- and middle-income countries); assess and act upon issues identified during due diligence processes; assist in implementing training and communication plans; and

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contribute to monitoring, auditing and enforcement activities to ensure consistent application of Company policies. The individual will work in close coordination with colleagues in Legal, Business Conduct, Internal Audit, Finance, and other departments to complement existing compliance activities. Essential Duties and Job Functions: • Participate in implementation of the Company’s anti-corruption program, including assessment and appropriate follow-up on issues identified during due diligence processes relating to engagement of third parties; • Work collaboratively with other functional groups and relevant stakeholders to advance the Company’s anti-corruption program; • Provide input on development and maintenance of anti-corruption-related policies; • Provide business conduct and compliance support to Access Operations & Emerging Markets, including development and refinement of policies and procedures; • Help develop and deliver training for employees and agents; • Assist in providing day-to-day guidance, support and problem solving; • Participate in monitoring and reporting framework for key activities to assess the effectiveness of the program; analyze and monitor results to identify trends and recommend program improvements; • Participate in cross functional audits of affiliates and third party agents and assist in implementation of corrective actions; • Coordinate with other colleagues in Legal, Business Conduct, Internal Audit, and client departments on an international basis to ensure efficient and effective implementation of program; • Assist in monitoring external environment and recommend improvements to the company’s anti-corruption program based on identified industry best practices. • International travel required Knowledge, Experience and Skills: • Requires a Juris Doctorate or equivalent advanced degree • Bar admission • 6+ years of prior industry or law firm experience providing legal counsel relating to drugs, devices, or food products. Experience in biotechnology or pharmaceutical industries preferred. • Proven regulatory/pharmaceutical compliance experience with ability to analyze and interpret sales and marketing laws and regulations, and effect related organizational changes to ensure alignment. • Demonstrated leadership and project management in enterprise-wide projects • Ability to present complex information in an accurate and persuasive manner to all levels of management • Experience in fraud & abuse laws preferred (e.g., Foreign Corrupt Practices Act; UK Anti-Bribery Statute; Anti-Kickback Statute) Skills: • Strong project management, communication and interpersonal skills. Substantial knowledge of specific areas of law and business and ability to independently and effectively apply this knowledge to the relevant areas of responsibility to counsel members of the senior Legal team and senior managers in other departments; • Responsible for identifying and analyzing risk associated with complex problems within area of responsibility; • Must be a team player who can easily handle shifting priorities, multi-tasking in a deadline oriented environment; • Must be motivated and willing to take initiative; • Must have excellent written and verbal communication skills • A Counsel II must demonstrate good judgment in their area of responsibility. Part of this judgment is demonstrated by how s/he reasons through issues and identifies those issues where the judgment of a more senior attorney may be required before moving forward. ************************************************************************************ http://www.indeed.com/viewjob?cmp=Inovio-Pharmaceuticals,-Inc.&t=Associate+Director+Director+Regulatory+Affair&jk=180a4601b4745589&sjdu=QwrRXKrqZ3CNX5W-O9jEve-4ln2yVB5HIB92Wum0FxNbAJoU98f777x-3Idu9frT4Gj4mijJMqOEdQn_AIdp_BlBNqYOlOSI0turbIGVtQcOeSOSBL9OtB9LMKFQDix-

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TgPNmBUEIiWXshFpQ5AC-Q Associate Dir/Director of Regulatory Affairs, Medical Devices Inovio Pharmaceuticals, Inc. - San Diego, CA The Associate Director/Director, Regulatory Affairs, Medical Devices will assist the Senior Director in maintaining Inovio’s compliance with internal SOPs, local, regional, national, and international regulatory laws, standards, and regulations. The Associate Director/Director, Regulatory Affairs, Medical Devices will have a broad spectrum of responsibilities spanning regulatory submissions, health authority interactions, compliance and internal advisory activities. Essential Job Functions: Regulatory Submissions:

Sets strategy for device regulatory submissions to health authorities worldwide Oversees the organization and compilation of device regulatory submissions and other

correspondence to US and international regulatory agencies that may be considered moderately complex in support of Inovio’s pharmaceutical/medical device combination product in Phase I-III programs

Maintains up-to-date knowledge of the data, information, and formats required for inclusion in these applications

Utilizes regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained

Health Authority Interactions: Interacts with key personnel in regulatory agencies to ensure the review and approval of

development plans, the timely resolution of issues, and the approval of applications Effectively plans, organizes, and conducts formal meetings/teleconferences with regulatory

agencies for designated programs Regulatory Compliance:

Conducts internal compliance audits in accordance with applicable regulatory standards (e.g. FDA, MDD, ISO) in preparation for external quality system audits

Participates in external quality system audits with Inovio’s Quality Assurance and Engineering groups

Reviews and provides interpretive analyses of complex regulatory guidance documents, regulations, proceedings, or directives that impact Inovio’s products and operations to the Senior Director, Regulatory Affairs and management team for assessment of potential impacts on development programs

Internal Advisory Activities: Provides input and recommendations for device design and process verification and validation

activities with Inovio’s Engineering and Quality Assurance groups Develops device regulatory strategic plans and provides guidance to a cross-functional project

team Reviews and approves data and documentation required for medical device/pharmaceutical

combination product regulatory submissions Provides input into the development and maintenance of quality systems Participates on project teams and provides device regulatory updates and summaries to

management Minimum Requirements:

Bachelor’s/Master’s degree in life science or related area required Area(s) of expertise desired: Biology, Immunology, Bioengineering, Cell or Molecular Biology.

Experience with vaccines highly preferred A minimum of 10 years in regulatory affairs with a minimum of 5 years in medical devices Experience and knowledge of the relevant current requirements for medical device or

combination product submissions to US FDA and prior interaction or exposure with other key regulatory authorities (e.g. EMEA, EU competent authorities, APAC regulatory agencies)

Essential Requirements: Excellent oral and written communication, interpersonal and organizational skills, and

attention to detail Ability to consistently meet tight timelines and deadlines. Ability to interact effectively with

management and prioritize multiple projects

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Technical proficiency, effective problem solving and critical thinking skills Ability to work in a team environment

Application Instructions: A current US work authorization is required. For consideration, please send a brief cover letter describing your qualifications and a resume. For ease of processing, please type “SD RA, Medical Devices” into the subject line of the email message. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer. ********************************************************************************************************** http://www.indeed.com/viewjob?cmp=Creganna--Tactx-Medical&t=Senior+R%26D+Balloon+Catheter+Engineer&jk=955554e1e25a3706&sjdu=QwrRXKrqZ3CNX5W-O9jEvSYJ10NrhRoLoTgi_ivLbEbSbE1xnUHXss5Ehx75OCRNARXqLJSiVqaaacVYa4T2yDbhUMB_7pVEhuHMGOPeFJg Sr. R&D Balloon Catheter Engineer Creganna-Tactx Medical - Campbell, CA Creganna-Tactx Medical serves medical device and life science companies, specializing in products, technologies and solutions for minimally invasive therapies. We are the partner of choice for the world’s leading medical device companies. The company adheres to a core value system that delivers customer satisfaction, exceptional service, outstanding quality and innovative solutions. Creganna-Tactx Medical takes a vested interest in promoting an environment where employees are rewarded, respected, and engaged. Creganna-Tactx Medical provides: a competitive salary, a comprehensive benefit package, 100% employer paid life and long term disability insurance, 401k, bonus potential and educational reimbursement (12k per year). We are currently seeking a Senior Research and Development Balloon Catheter Engineer. The ideal candidate will have medical device experience, ability to adapt quickly to changing priorities and manage multiple projects simultaneously. We offer Paid Time Off, a Comprehensive Medical package, 401k matching, Life Insurance and Tuition Reimbursement. The Sr. R&D Balloon Catheter Engineer will be responsible for developing and managing multiple projects. This position requires a candidate with product development experience in the medical device arena specializing in PTA& PTCA catheters, Angioplasty Devices, Stent Delivery Systems and Balloon Catheters. ESSENTIAL DUTIES AND RESPONSIBILITIES: The successful candidate will:

Be responsible for the technical development of catheter based products from concept through to completion.

Develop processes for producing prototype and production grade composite shafts. Manage multiple projects, budgets, and associated resources. Identify opportunities to leverage off of existing competencies. Develop and qualify processes to produce and assemble catheters. Prepare, manage, and execute equipment installations, process qualifications and product

validations. Identify and interact with vendors to obtain materials and equipment. Develop relationships with customers with a view to identifying and quantifying further

opportunities. Maintain product files and other relevant documentation to comply with quality standards. Other duties as assigned

REQUIREMENTS: 5+ year’s industry experience in a medical R&D or Process Development environment A Bachelor of Science Degree in Mechanical Engineering Experience in PTA/PTCA catheters Angioplasty Devices, Stent Delivery Systems and Balloon

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Catheters. Working knowledge of biocompatible metal and polymer materials. Must show proven capability to have excellent communication skills, motivation and be

proactive. An ability to work on teams and as individual and take ownership for both customer and

Creganna-Tactx goals and objectives. Proven project management skills and experience, including design control procedures and

Medical Device regulatory procedures. Knowledge of minimally invasive Medical Device design, development and manufacturing with

Class II and III devices. Experience in requirements for ISO 13485, GLP, and GMP environments. Experience of design tools including Solid Works/CAD, DOE, 6 sigma principles and practices,

FMEA, problem solving, product testing, report writing & statistical analysis including Minitab an advantage.

Solid understanding of design control procedures, deliverables and ability to demonstrate those skills.

Knowledge of design verification/validation activities including; Sterilization, biocompatibility, packaging, aging, design verification & process validations.

********************************************************************************************************** https://www.ziprecruiter.com/job/Regional-Sales-Director-West-Coast/962e3ab7/?source=cpc-indeed-campaign1-indeed Regional Sales Director - West Coast San Diego, CA Posted 16 days ago in Sales & Biz Dev

Our client is a premier provider of an innovative healthcare information technology (HIT) system sold to hospitals. They are seeking a West Coast Regional Sales Director (RSD) with experience selling software and solutions to multiple levels of decisions makers, including C-Level executives. This is an exciting opportunity to join a growing start-up with experienced leadership and strong financial backing. The company has already had success selling in territories throughout the US. They are expanding, and need a strong RSD to handle sales and business development in California, Oregon, Washington, Nevada, Idaho and Montana. Qualifications

Minimum 3 years of healthcare sales experience Hospital and physician practice sales experience Previous experience covering a large multi-state territory Self-motivated and competitive with strong organizational and interpersonal skills Must possess client contract experience and reading, negotiating and pricing skills Background calling on IDN's and community health networks preferred Degree or equivalent industry experience required

Compensation Base Salary $75,000.00 - $80,000 plus commission Total Compensation $130,000.00 - $150,000.00 Mileage reimbursement, equipment and laptop provided Benefits

Medical, Dental, Vision Life Insurance Employee Assistance Plan Ability to accrue up to 15 days of paid time off within first year of employment Six recognized holidays

About Presented by Raindance Partners: About Raindance Partners: Raindance Partners is a national recruiting firm with headquarters in Santa Barbara, CA. For almost a decade, Raindance Partners has focused solely on recruiting the best candidates into high-growth companies in the Biotechnology, Life Science, Diagnostic, Medical Device, Technology and Hospitality industries.

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We have been exclusively contracted by our client to to source, qualify and present candidates that map to the job description specifications. All applicants will be considered. ************************************************************************************************************ http://webconnect.sendouts.com/CN_Frame.aspx?ID=Transition&SiteID=WebConnect&Group=WebConnect&Key=CN&CNTrackID=7&MTTrackID=7&CnId=&PostId=4970bce8-1307-4010-807e-20d926cb24bb&ApplyNewCan=0 Accounting Manager Transition Staffing Group, Inc - Carlsbad, CA We have an outstanding opportunity with a pre-IPO organization. This is a rare opportunity to get your foot in the door with a Medical Device company with options tied to the position. We are open to looking at candidates coming straight out of public accounting or an existing Accounting Manager/Senior Accountant with a CPA or SEC exposure. If you are interested in the amazing opportunity, please email your resume to John at John@CallTSG.com or Shaun at Shaun@CallTSG.com Accounting Manager This position will be directly responsible for preparing internal and external financial reports, overseeing financial statement close process, coordinating audits and tax return compilations as well as the accounting of our diagnostic testing service lab. This position will report to the Director of Finance. PRIMARY DUTIES & RESPONSIBILITIES: : Ensure timely identification and compliance with evolving accounting guidance, provide US GAAP interpretation and prepare technical memorandums that document issues. : Assess accounting treatment for non-standard transactions, including revenue recognition : Oversee timely accounting close process. : Prepare monthly internal and external financial reports, and internal business performance reports. : Review account reconciliations performed by other accountants and reconcile certain accounts. : Perform stock compensation accounting and assist in administration of equity incentive plan. : Assist preparation of financial statements including footnotes, coordinate annual audit and income tax return compilation. : Document, implement and maintain accounting procedure manual and internal control policies. : Other duties as assigned. Requirements: : Bachelor's degree or higher in Accounting, with excellent knowledge of US GAAP : 3-5 years of relevant industry experience, manufacturing experience is preferred : Licensed CPA with 2-3 years of experience at a national accounting firm : Analytical, proactive, ability to work in a fast-paced environment, manage well through ambiguity and complexity : Independence, problem-solving abilities, willingness to roll up sleeves to get the work done, and the ability to work in a team with good interpersonal skills are essential : Flexible and able to manage numerous projects simultaneously strong organizational skills and attention to detail : Fun and energetic Transition Staffing Group, Inc - ************************************************************************************Apply at https://allergan.taleo.net/careersection/external/jobdetail.ftl?job=135301&src=JB-10300 VP, Global Strategic Mktg Allergan, Inc. - Irvine, CA

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Job Number: 141438 Description The Vice President of Global Strategic Marketing (GSM), Medical is responsible for the global marketing strategy and activities designed to increase the net value of the Allergan Medical franchise -- $1,600M+ device and drug business which includes world leading brands in Breast Aesthetics (Natrelle® and Seri®, a unique silk derived scaffold), Facial Aesthetics (Botox®, Juvederm®, Latisse®), and physician-dispensed skin care products. The role communicates with our commercial regions and provides their input into our R&D and Business Development teams to drive the successful attainment of our global franchise, sales, and profit goals. The role will help define the long term strategy of the franchise and drive implementation of this strategy with central functions including Manufacturing, Regulatory, R&D and Business Development. It works closely with the regions in preparation for product launches and building strategy. Serves as a member of the Global Strategic Marketing Team to establish the long-term strategic direction and ensure achievement of the annual operating plan and budget for the division. Principal Responsibilities: The Vice President, Global Strategic Marketing, Medical will: Direct the global strategic plan based on sound data to meet business requirements and product potential, expand the business through: Creation and dissemination of global strategic plans to central functions, regional marketing and applicable leadership teams Creation of core launch packages for new products Recommendations for license and acquisition of new products or businesses Recommendation for allocation of resources among product lines to maximize sales growth and profitability- short, medium and long term. Lead the cross-functional strategic planning process for the GSM, Medical franchise designed to maximum value of strategic portfolio and brands. Represent the Commercial interest and valuation within internal development activities by providing marketing input, guidance and direction to R&D, Regulatory, Clinical, Business Development, and Manufacturing functions. Jointly with these businesses, ensure R&D, Regulatory, and Manufacturing priorities support GSM, Medical business goals. Establish and collaborate with consultants, key opinion leaders, and professional influencers to identify unmet medical and rejuvenation needs, create target product profiles and validate assumptions in valuation models. Direct the Product Development process in R&D by providing sound data, accurate customer insights and reliable forecasts that inform portfolio analysis. Develop and manage the departmental budget and allocation of resources to achieve divisional revenue, and profit, and market share targets. Provide leadership by communicating direction, establishing challenging goals, setting high standards and expectations, developing talented people and recognizing outstanding contributions. Manage, direct, develop, and coach a team of marketing professionals: Direct reports: 4-5

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Indirect reports: 15-20 (senior/directors, senior/managers, individual contributors Qualifications Additional Preferred Experience: Four (4) year university degree required. Advanced degrees and certifications, preferred. Broad knowledge of the Medical Device & Pharmaceutical industries. “In-line” and “global” marketing experiences. Ability to influence through relationships. Demonstrated communication skills (verbal, written, and presentations) with audiences of varying levels. Demonstrated experience in working within multi-culture environments. Ability to work in a fast-paced, dynamic atmosphere. Ability to work in new technology areas. Experience working with/on development teams. Ability to build teams and grow talent. Proficiency with office technology and applications, and social media platforms. Up to 50% Travel. Employee Status : Regular Primary Location : USA-CA-Irvine Job ****************************************************************************************************** Apply at https://www.smartrecruiters.com/CurexoTechnologies/75786651-regulatory-affairs-manager Regulatory Affairs Manager Curexo Technologies - Fremont, CA Job Description Job Summary: The manager of Regulatory Affairs is responsible for developing strategies for worldwide governmental approvals/clearances to introduce new and modified products to the market, advises onregulatory requirements, prepares worldwide regulatory submissions, and negotiates product

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approval. To ensure compliance with all applicable domestic and international (US and out of US) regulations and requirements. Experience within the medical device industry with knowledge performing their function within the Food & Drug Administration (FDA) Quality System Regulations (QSRs), International Organization of Standardization (ISO) 13485:2003, Medical Device Directive (MDD) 93/42/EEC and ISO 14971:2007. The incumbent has the ability to take strategic direction and establish efficient and compliant processes throughout the organization and has strong communication at all levels. Travel Requirements: ≤10% Training opportunities, Regulatory Agency meetings, Distributors, Clinical Sites, Suppliers. Responsibilities: Plan, coordinate and prepare documents packages for regulatory submissions, including FDA 510(k), IDE, PMA(s), Design Dossiers, Shonins, Device License Applications, and internal “Letters to File”. Responsible for Regulatory Affairs support of submissions and on-going regulatory compliance for product development process. Prepares complex submissions to gain approvals for, export, and commercial distribution for device such as: IDES, IDE Progress Report, Clinical Trial Submission, 510(k), PMA, PMA-S, PMA Annual Report, HUD Designation, HDE< Shonin, Design Dossiers, and CE-Mark Technical File. Negotiate directly with the Regulatory Agencies on applicable products/projects. Develop and implements regulatory strategies for new and modified products. Responsible for foreign registrations and “Permission to Export” documents. Maintain submission correspondence files and other regulatory files in a complete and secure manner. Create project deliverables, aligned with appropriate internal and external guidance documents. Maintain annual facility registration and device-listing documents. Ensure that existing approvals and documents are maintained. Review device labeling and advertising materials for compliance with global regulations; analyze and recommend appropriate changes. Review and sign off on product and manufacturing or major business segment products lines, special projects or strategic initiatives. Review and approve regulatory submissions and approvals, including design and manufacturing changes, labeling, web page content, and advertisements. Provide regulatory input in quality system assessments, product development, and complaint/MDR/Vigilance handing system. Review and approve test protocols to support regulatory submissions. Support the CTC Quality Policy and Quality System. Provide input on and reviews Design Control documentation such as: Risk Management, design verification, design validation, shelf life studies, pre-clinical studies, and clinical studies. Monitor and research changes in the regulatory and competitive environment, evaluate impact and communicate to interested parties. Provide regulatory feedback and guidance throughout the product development cycle, and coordinate team inputs for submissions on manufacturing and development teams. Initiate, follow-up, negotiate, and resolve issues regarding current and future submissions, under minimal direction, up to and including travel to, and direct discussions with the appropriate regulatory agency. Act as company representative, develop and maintain positive relationship with device reviewers through oral and written communications regarding pre-submission strategy, regulatory pathway development, testing requirements, clarification and follow-up of submissions under review. Provide project, department, and company guidance and training based on current and emerging regulatory affairs and requirements, regulations, and processes, and focus on improved regulatory efficiency and effectiveness. Provide technical guidance and regulatory training, mentoring to other Regulatory Affairs employees and cross-functional teams. Develop and implement departmental and divisional policies and procedures. Participate on Corporate initiatives as appropriate. Other duties as assigned. Qualifications Qualifications: Bachelor's degree and a minimum of 10 years experience in the medical device industry and 4 years in a management role. Demonstrated success in a start-up, entrepreneurial work environment. Through knowledge of FDA Quality system requirements, ISO 13485:2003 (Quality System) requirements, ISO 14971:2007 (Risk Management) requirements, Medical Device Directive (MDD) requirements, and knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.

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Through understanding of: Awareness of international regulatory requirements and systems. 8+ years Regulatory Affairs medical device industry experience. Demonstrated expertise in management of regulatory submissions activities. Demonstrated project management skills and experience. Proficient in timely review of technical and clinical data. Proficient in FDA and international regulations. Technical knowledge of medical devices. Ability to write clear, concise, and well thought out technical documents. Ability to take leadership role in regulatory and/or cross-functional team. Strong leadership, organizational, interpersonal skills Good presentation skills. Computer skill: MS Word, PowerPoint, MS Project, Adobe Acrobat, Visio, Excel, Database. FDA medical device regulations, guidance, and import/exports requirements Medical device labeling and promotional requirements Product development processes Curexo Technology Corporation offer a fast-paced work environment, and a very competitive compensation, medical and 401K retirement plan benefits available We are an equal opportunity employer and encourage diversity. To apply: Please submit resume and Cover Letter to HR dept at jobs@robodoc.com Company Overview: The Company is a pioneer in medical robotics and world leader in image-directed, robotic products for orthopedic applications. The Company’s product allows surgeons to pre-operatively plan their surgery in a 3-D virtual space and then execute the surgery in the operating room, exactly as planned. Additional Information Curexo Technology Corporation offers a fast-paced work environment, very competitive compensation, medical and 401K retirement plan benefits.

. ****************************************************************************** http://www.zyomyx.com/about/careers/ Current Openings Process Engineer Systems Engineer Production Supervisor Buyer/Planner Facility Supervisor Document Control Specialist Maintenance Technician QC Technician Assemblers *****************************************************************************

Jobs That Crossed My Desk Through March 23, 2014 ***************************************************************************** For consideration, please apply online at www.exponent.com/careersand reference “3962” as the keyword, or click here: Application Page (3962). Job Summary Date Posted:

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3/19/14 Location: Menlo Park, CA

Recruiting Manager Exponent Job Description Exponent is a leading engineering and scientific consulting firm. Our multidisciplinary team of scientists, engineers, physicians, and regulatory consultants brings together more than 90 different disciplines to solve complicated problems facing corporations, insurers, government entities, associations and individuals. Our approximately 900 staff members work in 25 offices across the United States and abroad. Exponent has over 600 consultants, including more than 350 that have earned a doctorate in their chosen field of specialization. Exponent’s Biomedical Engineering Practice evaluates biomaterials, surgical instruments, and implantable devices utilizing state of the art experimental, imaging, and finite element techniques. Exponent’s Medical Device professionals evaluate novel technologies and characterize product performance in support of our clients’ new product development activities or as part of safety and functionality assessments, failure analyses, or scientific marketing efforts once their devices are already in clinical use. We are equipped with state-of-the art laboratories and test facilities and have dedicated computational resources, as well as a research library containing thousands of research articles. Exponent’s unique combination of expertise enables our Medical Device specialists to research, analyze, and model the complex mechanical interactions between humans and orthopaedic, spinal, cardiovascular, neurologic, biologic, and combination medical devices. We also consult in intellectual property and product liability matters related to medical devices. The Biomedical Engineering Practice is currently hiring for a Regulatory Senior Managing/Principal Engineer/Scientist in our United States offices. This position offers a stimulating and challenging work environment and significant opportunities for professional growth. Responsibilities for this position include:

Manage and execute complex projects related to preclinical strategy and all phases of the FDA product review and approval process of medical devices in support of our clients

Active participation and leadership in our Biomedical Engineering Practice Actively market the group’s technical capabilities to clients and the scientific community Develop additional expertise, gain additional industry exposure, and establish new and expanded

client base through our unique technical consulting services Attract and develop new projects and clients

Qualifications for this position include: M.D., J.D., or M.S./Ph.D. in Bioengineering, Mechanical Engineering, Materials Engineering,

Polymer Science or a related engineering field Direct experience in a product development environment in medical devices is required, including

working knowledge of medical device design control, Risk Management, MDR and FDA regulatory environments

Demonstrated experience in working with FDA and successful completion of 510(k) submissions and pre-IDE, IDE, PMA original submissions and subsequent revisions/supplements for medical devices

Minimum of ten years of professional experience, with a minimum of five years as a consultant Outstanding verbal and written communication skills in order to effectively communicate highly

technical issues to a non-technical audience while possessing the technical depth to collaborate with physicians and interact with regulatory bodies

Must be a recognized expert in his/her field with a strong publication history Established client relationships and a thriving consulting business is highly desirable Must be able to attract projects and continuously expand his/her business volume to support full-

time staff and have the skills needed to manage, develop, and promote a group of highly motivated professionals

Testifying experience in trials and/or before government panels is an asset

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The ideal candidate will be expected to continuously expand his/her own expertise through peer-reviewed publications

Exponent provides a competitive compensation package, excellent benefits, including company-subsidized medical, dental, vision, life insurance, and a 401(k) Retirement Program, with a 7% company contribution. We are an Equal Opportunity Employer. ****************************************************************************************************************** https://jobs.smartbrief.com/action/listing?listingid=A8A2F045-54A4-40BC-8B5C-75D737C2F50A&briefid=3e572e18-3fbc-11d5-ad13-000244141872&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0&utm_source=brief For additional information, please visit www.ropesgray.com Job Summary Date Posted: 3/19/14 Location: Boston, MA; San Francisco, CA; Silicon Valley, CA, MA Years Experience: 3-5 Corporate Life Sciences Lawyer (3-5 years exp) Ropes & Gray LLP Job Description Ropes & Gray is currently seeking a mid-level associate in Boston, San Francisco or Silicon Valley to join its Corporate Life Sciences Group. The ideal candidate a will have:

3-5 years of capital markets, corporate governance, and mergers & acquisitions experience Experience in venture capital and representing clients in the life sciences industry, including

pharmaceutical companies, biotechnology companies, medical device manufacturers and research institutions is a plus.

JD from a reputable law school Ropes & Gray is a leading global law firm with offices in Boston, Chicago, Hong Kong, London, New York, San Francisco, Seoul, Shanghai, Silicon Valley, Tokyo, and Washington, DC. For additional information, please visit www.ropesgray.com. ******************************************************************************** Robin C. Stracey Apex Life Science Advisors LLC Retained Executive Support for Life and Health Science Companies EMail: robinstracey@alumni.gsb.stanford.edu or robinstracey@apexlsa.com Cell: 408-203-1973 Opportunity for a commercial head for Americas and APAC A client company of mine will very soon be looking to hire a commercial head for the Americas/Asia Pacific region for one of its Divisions. The Company is a $300MM Private Equity backed leader in life sciences, and the Division concerned (Genomics) has particular strength in the AgBio arena. Though the company is based in the Boston Area, and supervision of a lab operation and office personnel in the Boston area will be part of the new hire’s responsibility, a relocation is not required as long as the new hire is comfortable with frequent and extensive travel. The ideal candidate will be a strong commercial leader on a fast track to General Management with experience in a fast paced environment. The Genomics Division has come together through a series of acquisitions and is in the late stages of completing full integration. The Division is about $50 Million in size with significant growth – and further acquisitions – expected in the

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Americas. The role will report in to the Divisional head located in the UK and is pegged at around $250k plus equity. If any of you have contacts that you feel may have an interest, please let me know or refer them to me. ************************************************************* For more information about this job and several others that are available, or to apply, you need to go to: http://www.ultragenyx.com/index.php?ht=d/ContentDir/pid/289 Ultragenyx (in Novato) has several fulltime positions available - they are hiring to support 5 drug programs! The general discription for the Manager/Sr. Manager of Regulatory Affairs position is below. Manager/Sr. Manager, Regulatory Affairs

Preferred Degree: Bachelors Job Type: Full Time

Experience (Years): 6-8 Job Category: Regulatory Affairs

Created: 03-May-2013 12:11 Job Description The Manager, Regulatory Affairs will be responsible for managing all regulatory aspects (nonclinical, clinical, CMC) of a substrate replacement therapy program with multiple indications. The responsibilities include working closely with functional areas and project teams to support product development and approval. The individual must possess a thorough knowledge of global rules, regulations, and guidances governing drugs and biologics in all phases of development. Strong communication and management skills are required. The position level is dependent on experience and qualifications. ****************************************************************************************************************************** Job Summary Date Posted: 3/14/14 Location: Foster City, CA

Counsel II, Legal (Anti-corruption) Gilead Sciences Inc Job Description Specific Responsibilities: This position will report to the director of Gilead’s anti-corruption program within Commercial Legal. The individual will help implement an effective cross functional anti-corruption program at Gilead Sciences. The individual will help develop and carry out policies and procedures; provide business conduct and compliance support to Gilead’s Access Operations and Emerging Markets (Gilead’s program to increase access to medicines and healthcare in low- and middle-income countries); assess and act upon issues identified during due diligence processes; assist in implementing training and communication plans; and

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contribute to monitoring, auditing and enforcement activities to ensure consistent application of Company policies. The individual will work in close coordination with colleagues in Legal, Business Conduct, Internal Audit, Finance, and other departments to complement existing compliance activities. Essential Duties and Job Functions: • Participate in implementation of the Company’s anti-corruption program, including assessment and appropriate follow-up on issues identified during due diligence processes relating to engagement of third parties; • Work collaboratively with other functional groups and relevant stakeholders to advance the Company’s anti-corruption program; • Provide input on development and maintenance of anti-corruption-related policies; • Provide business conduct and compliance support to Access Operations & Emerging Markets, including development and refinement of policies and procedures; • Help develop and deliver training for employees and agents; • Assist in providing day-to-day guidance, support and problem solving; • Participate in monitoring and reporting framework for key activities to assess the effectiveness of the program; analyze and monitor results to identify trends and recommend program improvements; • Participate in cross functional audits of affiliates and third party agents and assist in implementation of corrective actions; • Coordinate with other colleagues in Legal, Business Conduct, Internal Audit, and client departments on an international basis to ensure efficient and effective implementation of program; • Assist in monitoring external environment and recommend improvements to the company’s anti-corruption program based on identified industry best practices. • International travel required Knowledge, Experience and Skills: • Requires a Juris Doctorate or equivalent advanced degree • Bar admission • 6+ years of prior industry or law firm experience providing legal counsel relating to drugs, devices, or food products. Experience in biotechnology or pharmaceutical industries preferred. • Proven regulatory/pharmaceutical compliance experience with ability to analyze and interpret sales and marketing laws and regulations, and effect related organizational changes to ensure alignment. • Demonstrated leadership and project management in enterprise-wide projects • Ability to present complex information in an accurate and persuasive manner to all levels of management • Experience in fraud & abuse laws preferred (e.g., Foreign Corrupt Practices Act; UK Anti-Bribery Statute; Anti-Kickback Statute) Skills: • Strong project management, communication and interpersonal skills. Substantial knowledge of specific areas of law and business and ability to independently and effectively apply this knowledge to the relevant areas of responsibility to counsel members of the senior Legal team and senior managers in other departments; • Responsible for identifying and analyzing risk associated with complex problems within area of responsibility; • Must be a team player who can easily handle shifting priorities, multi-tasking in a deadline oriented environment; • Must be motivated and willing to take initiative; • Must have excellent written and verbal communication skills • A Counsel II must demonstrate good judgment in their area of responsibility. Part of this judgment is demonstrated by how s/he reasons through issues and identifies those issues where the judgment of a more senior attorney may be required before moving forward.

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Other Information for Those in Transition

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************************************************************************* *********************************************************************** 4 Expert Tips on Writing a Resume for Biotech Industry, Nov 25, 2013 by Clinovo Read at http://blog.clinovo.com/4-expert-tips-on-writing-a-resume-for-the-biotech-industry/ See article entitled “6 Ways to Crack the Hidden Job Market” about cracking the hidden job market where 80% of jobs are found. The article was written by Nancy Collamer, M.S., is a career coach, speaker and author of Second-Act Careers: 50+ Ways to Profit From Your Passions During Semi-Retirement. Her website isMyLifestyleCareer.com; on Twitter she is @NancyCollamer. http://www.forbes.com/sites/nextavenue/2013/08/12/6-ways-to-crack-the-hidden-job-market/2/ ******************************************************************** Nice piece on informational interviews by Susan Oct. 22, 2012 at Work Coach Cafe at http://www.workcoachcafe.com/2012/10/22/how-to-do-successful-information-interviews/ Thanks to Paula Rutledge for sharing. ***************************************************************** Check out the annual Beyond Borders: Global biotechnology report 2012 on the biotechnology industry at www.ey.com. This is the 26th anniversary issue using consistent measures to track the industry sector. http://www.ey.com/Publication/vwLUAssets/Beyond_borders_2012/$FILE/Beyond_borders_2012.pdf See Beyond Borders Matters of Evidence 2013 biotechnology report at http://www.ey.com/Publication/vwLUAssets/Beyond_borders/$FILE/Beyond_borders.pdf *************************************************************** Check out the CHI.org website for the most recent publications on the status and trends of the California Biomedical Industry and workforce. These reports were prepared by leading organizations that research the market and lobby for the industry-- PWC, CHI and BayBio. They contain useful information for individuals as well as companies in researching the industry here locally. See 2013 report authored by CHI, PWC and BayBio at http://www.californiabiomedreport.com/ ******************************************************* Writing Resumes UC Davis Internship and Career Center Guide to Resumes (2011) Download at http://iccweb.ucdavis.edu/pdf/crm/0910/crm-resumes.pdf _____________________________________________________________ NOVA workboard releases a report that is of interest to those looking for new opportunities-- Tech Resumes 2.0, an Employer Perspective Silicon Valley in Transition: Tech Job Growth Poses Both Opportunities and Challenges for the Valley- Based on 250 employer surveys and over 50 executive interviews. As a portion of that effort, NOVA released a 2nd report: “Silicon Valley in Transition: Economic and Workforce Implications in the Age of iPads, Android Apps and the Social Web.” It proposes a number of recommendations for better preparing and connecting job seekers with available employment opportunities and for Silicon Valley to maintain its dominance as the world’s preeminent innovation factory. Tech resumes 2.0, an Employer Perspective - The study includes resume advice from 27 Valley recruiters and hiring decision makers as well as practical employment search and resume tips, key messages for job seekers, employers, economic development leaders, educators, and workforce boards. A link to the report is http://goo.gl/uXTX7 ______________________________________________________________ Susan Caldwell wrote an article regarding writing a resume as well. “10 Tips for Creating a Door-Opening Resume” by Susan E Caldwell If you're a medical writer, how can you make sure that you still have work in these tough economic times? Important for staff and freelancers alike, marketing your name

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and abilities can be done in many ways. One way is to develop and maintain a living resume that speaks to the best you have to offer employers. As an experienced worker, you likely have a professional reputation. Maybe it's good, or maybe it's not so good. How can you enhance or improve your resume so that your best shines through? Here are a few suggestions: 1. Resume Format. Your resume's format should be simple and pleasing to the eye. Because resumes are often input into databases, the simpler the format, the better. Using a simple format should help avoid the need to reformat before your resume is uploaded into a database. When you submit your resume to a recruiter or job board, you should submit it as a Microsoft Word file, but without special formatting. Avoid bullets, bolding, italics, indents, and other formatting that are lost in plain text files. If you do use special formatting, your resume may look like alphabet soup after it's put in a database. Organize your resume in sections, each with a heading that tells the reader what is in that section. Here are some sections typically found in resumes and their approximate order of appearance: Introduction or Career Goal Summary Work History or Professional Accomplishments (if candidate has work history) Academic Background Skills Honors and Awards Publications There are many variations on the organization and section labels listed above, and you should use what is appropriate for your career stage. Points 7-10 (below) specifically address what content should be included in some of your resume's major sections. When you are ready to format your resume, consider looking at the many examples of resumes available online. Seeing the structures of other resumes may help you decide on your own resume's format and organization. 2. Job Targeting. Decide what your target job or assignment is, and tailor your resume to that job. How do you do that? For one thing, you can pepper your resume with the key concepts, terms, and abbreviations for your target job in your resume; this will show that you know the language in that field. Examples include the terms ICH Guidelines, investigator brochure (IB), style guide, and eCTD. Another way to target your resume is to rewrite portions of your resume to match the target job description. This strategy sounds like a lot of work, but it can pay huge dividends. When you submit a targeted resume, it's more likely you will be considered a great match for the position. 3. Resume Emphasis. Emphasize your best accomplishments (for example, an approved eCTD submission that you worked on). Make it clear that you got the job done in an effective way, particularly if it saved time or money. You can do this by positioning these stellar achievements toward the resume's front, writing more about those accomplishments, and/or including specific comments about them in your resume. If there's a web site or information on the web that illustrates or supplements information about your accomplishment, link that information to your resume. 4. Lying on Your Resume. This one is simple: don't lie on your resume. It's a bad idea for several reasons. Not only is it wrong, but if you exaggerate or lie, you may be in over your head if you do get the job. In addition, employers do check resume facts, and they are likely to identify any lies or inconsistencies. 5. Errors in Your Resume. If you're seeking a new job or contract assignment, your resume should be flawless. That is, it should have no typos, misspellings, incorrect grammar, or other writing errors. If you want to open the door to a job interview, show the reader that you are careful about your writing. As a medical writer, the writing that appears in your resume will be the first writing sample an employer sees. Be sure that it will stand up to scrutiny.

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6. Resume as Living Document. Ensure that your resume is always current and well crafted; it should be a living document. Update it every time you have new material to add to it. Again, the resume's purpose is to get your foot in the door for an interview. If you don't keep your resume current, you may miss a chance to include vital information, especially if you need it on short notice. For this reason, you should always be ready to send your resume to recruiters or employers on a moment's notice. The remaining points in this article address issues within your resume's sections: 7. Summary. At the start of your resume, include a short (usually 1 to 2 paragraphs) thumbnail summary of your work experience and academic background. It's also appropriate to have a statement that tells the reader what you want to do in your next job. 8. Academic Background. The academic background section should include your earned degrees, the name of the institution where you earned the degree, and the dates when they were conferred. If you have earned an advanced degree, this section may be a good place to list the title of your thesis or dissertation, if any. (Alternatively, your dissertation's citation can be included in your resume's Publications section.) A separate section following your academic background can include the continuing education and training courses you've taken. The list should include the subject matter (or course title) and date(s) when you had the training. And here's an important tip: whenever possible, include specific dates for the education and training. The dates add to your credibility, and their absence can be conspicuous. As you advance in your career, your academic background generally becomes less important than your work history. After you have a work history, especially in medical writing, consider moving the academic background information in your resume to a location following your work history. 9. Work History or Professional Achievements. In this section of your resume, include specific details about your work history. The reverse chronological work history format often works well, with your most recent job listed first. The work history section should describe your milestone accomplishments for each job or contract assignment. As with the academic background section, include the start and stop dates for the jobs and/or contract work that you've done. The dates will give you added credibility. 10. Publications. If you've authored any publications, put a list of them in your resume with the full citations in a consistent reference format. For publications with multiple authors, you should include all of the authors' names in the order that they appeared in the publication. Finally, try to get access to electronic copies of your publications on the internet. Consider hyperlinking those citations in your resume to the actual articles. In so doing, your reader can easily find and read examples of your work. You can also prepare a set of publication samples as a zipped file to provide to prospective employers. Done well, your resume will open many doors for you, including some you may want to walk through. There are many resources on the internet that will help you create an excellent resume. Take the time to use them, too! You'll be glad you did.

About the Author Susan Caldwell is a medical writer, PhD scientist, and entrepreneur. After 10 years of laboratory research, she made a major career course correction and never looked back. She found she could make a career of doing what she loves--writing--and applied it to her background in biomedical research. Since 1995, she has directed medical writers at five life-science companies, including her company, Biotech Ink, LLC. Her specialty is writing regulatory documents for clinical, preclinical, and manufacturing activities that support the development of biotechnology, pharmaceutical, and medical device products. She also has considerable experience writing book chapters, newsletters, brochures, white papers, web content, and many other document types. Susan has been writing and publishing the Biotech Ink Insider newsletter since October 2008. You can email Susan at caldwell@biotechink.com, phone her office (650-286-9300), see her LinkedIn

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profile, follow her on Twitter, and you're invited to join her Medical Writers Twibe (for which you have to have a Twitter account). Copyright 2009 Biotech Ink, LLC. All rights reserved. ___________________________________________________ “Writing Your Career Change Resume- 5 Tips,” Job-Hunt.org…your objective source of job search resources website; this might be helpful for those of you leaving a bench science position to another function inside a life science company. http://www.job-hunt.org/career-change/resume-for-career-change.shtml I googled several questions about writing a resume and was astounded that the different sites with free advice, templates, etc. Of course, some service providers were also listed. I googled Amazon’s top books for job hunters and writing resumes and found a list including one of my favorites What Color Is Your Parachute? 2013: A Practical Manual for Job-Hunters and Career-Changers by Richard N. Bolles. I found this book especially useful in helping me determine what types of job functions I liked best. ************************************************************************ 4 Expert Tips on Writing a Resume for Biotech Industry, Nov 25, 2013 by Clinovo Read at http://blog.clinovo.com/4-expert-tips-on-writing-a-resume-for-the-biotech-industry/ Free Newsletters to Keep You Informed Check out free newsletters delivered to your email box: • “Biospace’s “Genepool,” “Deals and Dollars,” and “Clinical Focus” • “FierceHealthCare,” “FierceHealthIT,” FiercehealthFinancial”, “FierceHealthPayer,” “FierceEMR,” “FierceBiotech,” “FierceMedicalDevices” and “FiercePharma” • “Drug DiscoveryOnline,” • “IN VIVO Blogspot,” “Pharm Exec blog” • “QMed Daily” (formerly DeviceLink.com) • “PRWeek Healthcare Newsletter” • enewsletters@fdanews.com PharmExecBlog.com at http://blog.pharmexec.com/ on the business of pharma http://realendpoints.com/blog/ on pricing and reimbursement Luke Timmerman’s blog on Xconomy. ********************************************************************* Ken Wu advises “I found this article titled, 7 Mistakes Job-Seekers Over 50 Make, via the American Society of Quality (ASQ) daily email update. It's worth reading if you're considering how to reposition your self for the upturn in the job market.” The link; http://internsover40.blogspot.com/2009/09/7-mistakes-job-seekers-over-50-make.html?WT.mc_id=EM3965M&WT.dcsvid=1541418993. ************************************************************************* Job Sites There’s a new biotech job site on the BIO website entitled Bio Jobs: The Talent Hub for Biotech at http://jobs.bio.org. You can search for open positions via various parameters. Review my weekly listings for individual recruiters and review their websites where they post jobs. Be sure to join the Bio2Device Group and their Linked In Groups where jobs are posted. There are specialized linked in groups that list jobs in the area of interest to its members. I’m a member of separate linked in groups in marketing and marketing research where I gather jobs for my weekly postings.

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The most known site for career and job listings is www.biospace.com which focuses on biotech and pharma. There’s another site which is focused on life science recruitment and placement; note featured company listings may be listed—www.beaker.com There’s website with jobs specific to medical device area at the www.legacymedsearch.com. Darshana Nadkarni posts medtech jobs in the jobs category, in her blog at www.darshanavnadkarni.wordpress.com. For any jobs that interest you, she advises you send resume directly to her at wd_darshana@hotmail.com. You can look up pharmaceutical jobs in your area by zip code at http://jobs.findpharma.com/careers/jobsearch. They include all functions in pharmaceutical companies. ************************************************************************* Susan E. Caldwell a local medical writer shares some insights into finally mastering touch typing. As writers, we must type to do our work, at least if we're using Microsoft Word or other word processor. Many writers become writers without knowing how to touch type (typing without looking at the keys). Touch typing at 40-60 average words per minute, which is industry standard, is roughly 3 to 4 times faster than you can write by hand. The links below are offered so that you can learn and practice touch typing for free (and they aren't presented in any particular order: 1. http://www.sense-lang.org/typing/ 2. http://play.typeracer.com/ 3. http://10-fast-fingers.com/ 4. http://www.learn2type.com/ 5. http://www.touch-typing-tutor.com/ 6. http://www.nimblefingers.com/ 7. http://www.alfatyping.com/ 8. http://www.typeonline.co.uk/typingspeed.php ************************************************************************* Salary Surveys See most recent life scientist salary survey from The Scientist at http://www.the-scientist.com/?articles.view/articleNo/32918/title/Life-Sciences-Salary-Survey-2012/ Contract Pharma publishes an annual salary survey for employees of contract manufacturing companies at http://www.contractpharma.com/contents/view_salary-survey/2012-06-19/2012---thirteenth-annual-salary-survey/. The most recent Medtech survey for R&D can be found at http://www.mddionline.com/article/more-work-fewer-perks-medtech-employees. You can also find salaries for other functions at the same location. MM&M reports salaries in the September issue each year. See 2012 results at http://media.mmm-online.com/documents/40/2012_survey_9911.pdf ************************************************************************* Given the current economic climate, this is a wonderful time to prepare for a career transition and to reassess your career path so that it is aligned with your personal and professional goals. Career Opportunities in Biotechnology and Drug Development, www.careersbiotech.com, published by Cold Spring Harbor Laboratory Press, is a comprehensive, in-depth exploration into the many careers found in the life sciences industry (biotech, pharma and medical devices), based on interviews with over 200 industry executives. It covers 20 vocational areas and over 100 careers. The book was written with the goal of helping readers identify career areas that best suit their interests, values, skills and goals. Each chapter explores the many in-depth nuances of each vocational area. Additionally, there are chapters on resume preparation, job search strategies, informational interviewing and more. A free sample chapter on careers in Project Management is available at www.careersbiotech.com.

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This insightful and extremely helpful book was researched and written by Toby Beth Freedman, Ph.D., President, Synapsis Search (www.synapsissearch.com) and local guru on life science careers. Toby freely shares her experiences acquired as a researcher, business development manager, recruiter and her indepth research with local industry organizations, such as, local AWIS, the Bio2Device Group and universities. The target audience for this book is people working in academia or in industry who are considering a career transition. It has a broad appeal to scientists, doctors, nurses, lawyers, engineers, business executives, high tech professionals, etc. The book is available on Amazon and a paperback version will be available soon. ************************************************************************* These job postings are listed on my blog accessed at www.audreysnetwork.com/blog along with my suggestions for local industry meetings for networking and expanding your knowledge and skills. Please direct other interested parties to my email address at audreyerbes@aol.com if they wish to receive these mailings directly. *************************************************************************