Job Description
Position: Manager, Global Medical Affairs Research
Location: Foster City, CA 94404
Duration: 6 Months
Job Type: Contract
Work Type: Onsite
Payrate:$ 55.00 - 61.00/hr.
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions tour clients world-wide. The below job opportunity is with one of our Biotech clients whresearches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.
Description:
- We are seeking a Manager within Phase 4 Research in LIVE (liver, inflammation, emerging viruses, and established products) tjoin our Global Medical Affairs Research team.
- This role is responsible for coordinating proposal reviews and supporting portfolimanagement of investigator-sponsored research (ISR), collaborative research, and MA-led -sponsored research across LIVE.
- The ideal candidate will have previous experience in Phase 4 research or clinical operations, and knowledge of the therapeutic area.
- This position is based at client's Foster City, CA location.
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:
- Coordinate proposal review meetings with RC Team Leads and RC Chairs
- Support creation and management of requests for proposals (RFPs)
- Support external investigators, MA scientific leads, Medical Scientists, and other stakeholders in developing and submitting rigorous research proposals to the client
- Support the management of the LIVE portfoliincluding 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 tensuring 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 ttrack, monitor and intervene with external investigators tensure 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 tprocess improvements related tresearch proposal and study management systems
- Manage projects tcompletion, 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
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 tregulatory 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 tdetail
- Ability twork in a global environment which may require participation in meetings outside of standard work hours taccommodate time zone differences
- Affinity for a collaborative, team-oriented environment, and approach; must be able tappropriately 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 twork independently and having a positive attitude while working as part of teams
- Ability tengage and manage multiple stakeholders tachieve 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
TekWissen® Group is an equal opportunity employer supporting workforce diversity.
Job Tags
Contract work, Local area,