Job Description
Job Description
Hybrid at FC 3 days a week onsite and 2 days remote
We are seeking an Associate Manager - Medical Affairs for a very important client.
Global Medical Affairs Research plays a key role in developing Integrated Evidence Plans (IEPs) that include a holistic view of prioritized data needs across the product lifecycle. We are seeking a well-organized professional to join the Global Medical Affairs Research team, reporting to the Head of Integrated Evidence Planning and Research Governance. This role will provide operational and logistical support to the IEP Execution Teams (ETs) across the Virology and Inflammation Therapeutic Areas (TAs), which includes HIV Treatment and Prevention, Hepatitis D, PBC, and established products for diseases such as Hepatitis B and C, and COVID-19.
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 client-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.
The candidate must have a professional demeanor representing client's core values of integrity, inclusion, teamwork, accountability, and excellence in every project.
The position is office-based in our Headquarters in Foster City, CA.
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