Responsibilities:
- Excellent employment opportunity for a Manager, Global Medical Affairs Research in the Foster City, CA area.
- Phase 4 Research in LIVE (liver, inflammation, emerging viruses, and established products)
- We are seeking a Manager within Phase 4 Research in LIVE (liver, inflammation, emerging viruses, and established products) to join our Global Medical Affairs Research team.
- This role is responsible for coordinating proposal reviews and supporting portfolio management of investigator-sponsored research (ISR), collaborative research, and MA-led Company-sponsored research across LIVE.
- The ideal candidate will have previous experience in Phase 4 research or clinical operations, and knowledge of the therapeutic area.
- 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 the company
- 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
Experience:
- 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
Job Type: Contract
Schedule:
- 8 hour shift
Application Question(s):
- Do you have experience in LIVE (liver, inflammation, emerging viruses, and established products) therapeutic area?
- Do you have experience in coordination with investigator-sponsored research (ISR)?
Work Location: In person
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