The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate’s/applicant’s qualifications, skills, and level of experience as well as the geographical location of the position.

Applicants must be legally authorized to work in the United States. Sponsorship not available.

Our client is seeking a Manager, Global Medical Affairs in Foster City, CA.

Role Description

Specific Job Responsibilities:
• Assist in managing meetings for our LIVE Research Committee (RC)
• Manage reviews of ISRs, COs and MA-led GS proposals through the RC review process for:
o Coordinate proposal review meetings with RC Team Leads and RC Chairs
o Support creation and management of requests for proposals (RFPs)
o Support external investigators, MA scientific leads, Medical Scientists, and other stakeholders in developing and submitting rigorous research proposals to Gilead
• Support the management of the LIVE portfolio including liaising with key cross-functional partners such as Clinical Operations, local affiliates and external investigators
• Review abstracts and/or manuscripts that result from the phase 4 program
• Contribute to ensuring that the research processes and study execution align with MA research policy and governance, integrated evidence plan priorities, and overall program strategy
• Work with the team to track, monitor and intervene with external investigators to ensure timely execution of contracted studies, and support closure of studies when not meeting contracted milestones
• Act as a resource for Research Committee Chairs, voting members, standing members, proposal champions, affiliates, and reviewers
• Contribute to process improvements related to research proposal and study management systems
• Manage projects to completion, anticipating obstacles and difficulties that may arise, resolving them in a collaborative manner and engage in project management activities as needed by assigned RC Team Lead and/or Senior Manager

Skills & Requirements

Educational and other Requirements:
• Professional degree (eg, PhD, PharmD); OR master’s degree (eg, MS, MPH) with 2+ years of experience in clinical or observational research including research operations; OR Bachelor’s degree with 6-plus years of experience
• Must be cognizant of and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; knowledge of FDA regulations, ICH guidelines and GCPs governing the conduct of clinical trials
• Demonstrated project management and organization skills including process improvement, management of multiple resources and priority projects with tight timelines while maintaining attention to detail
• Ability to work in a global environment which may require participation in meetings outside of standard work hours to accommodate time zone differences
• Affinity for a collaborative, team-oriented environment, and approach; must be able to appropriately interact within MA and across Development, senior management, and external customers/vendors
• Excellent interpersonal, written, and verbal communication skills
• Proven track record of executing clearly defined goals and objectives in a fast-paced environment
• Self-motivated to work independently and having a positive attitude while working as part of teams
• Ability to engage and manage multiple stakeholders to achieve the objective

Preferred Qualifications:
Understanding/experience in in MA/pharmaceutical industry in phase4/externally sponsored research programs or Clinical Development
Scientific knowledge/experience in LIVE Tas

Benefits/Other Compensation

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.

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