Job Description

Job Title: Manager, Global Medical Affairs Research

Location: Hybrid at FC 3 days a week onsite and 2 days remote

This role will also be responsible for providing operational support in global late phase research for the Oncology TA. This includes investigator-sponsored research (ISR), collaborative research, and MA-led Gilead-sponsored research. The ideal candidate will have previous experience in clinical operations or active participation in phase 4 research studies. Within global late phase research for Oncology, the position will work to ensure all steps of the MA research proposal review are well documented, compliant and consistent with standard operating procedures; evaluate and implement best practices within the Oncology Review Committee (RC); work with TA MA research leads to coordinate monthly research proposal reviews and protocol reviews.

Specific Job Responsibilities:

• Management of Virology & Inflammation IEP Execution Teams
• Manage ET meetings and workshop logistics: schedule in Outlook, confirm attendance of key participants, prepare and distribute meeting agendas, slides and other materials
• Capture and distribute meeting outcomes, action items, and timelines, following up with ET members to ensure timely execution of ET deliverables
• Manage ET rosters and distribution lists
• Maintain Study Trackers and Data Generation Summaries by collecting updates from ET members on a quarterly basis
• Support the creation of quarterly and ad hoc executive update reports
• Assist with refinement and standardization of IEP processes and tools across therapeutic areas to ensure that the best practices from one therapeutic area are incorporated into other areas
• Management of Oncology Medical Affairs Review Committee Meetings
• Provide logistical and project management support for the Review Committee meetings by scheduling meetings, drafting and finalizing agendas, managing deadlines, confirming attendance of key participants, preparing and distributing meeting materials, and ensuring meeting participants document their reviews.
• Assist team members in using appropriate templates and standardized documentation practices, managing the review process according to agreed-upon timelines
• Facilitate routing of materials to the appropriate group or location
• Answer or triage inquiries about MA Research processes and troubleshooting as they arise
• Act as subject matter expert in systems used for proposal and protocol reviews
• Contribute to improvements in systems and processes related research proposal and study management systems
  Manage budget approvals monthly

Knowledge & Skills:

• Established project management, process improvement, and organizational skills, including management of multiple priorities and resources while maintaining attention to detail
• Excellent verbal, written, and interpersonal skills are required
• Proven track record of executing clearly defined goals and objectives in a fast-paced environment
• Self-motivated to work independently and have a positive attitude while working as part of various teams
• Ability to apply logic and problem-solving skills under pressure and adapt to change
• Strong business skills/acumen and documentation practices
• Knowledge and skill with Smartsheet, Microsoft Excel, Word, PowerPoint, Outlook, and other reporting and tracking tools

Education & Experience:

• Professional degree (eg, PhD, PharmD) with 1-2 years experience in Clinical Development, Clinical Operations or
• Medical Affairs, OR master s degree (eg, MS, MPH) with 4 Years experience; OR Bachelor of Science degree with 6 years of experience in the pharmaceutical industry
• Must be fully 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
• Comprehensive understanding/experience in clinical and observational research, or experience in MA/pharmaceutical industry 3-5 years in phase4/ISR-related programs or Clinical Development

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