The Medical Affairs (MA) Operations manager is responsible for supporting efficient operations, vendor oversight, training, budgeting, reporting and project support for the Medical Affairs department, in accordance with compliance guidelines. The Project Manager will report to the Head of Medical Affairs and work in close collaboration with the Medical Affairs Leadership Team (MALT) and other key stakeholders. The MA Operations Manager also contributes to initiatives of process harmonization/Improvement.

Essential Responsibilities:

• Operational support for Medical Affairs team, including but not limited to:
  • Managing vendor onboarding process and Purchase Order generation for new/existing vendors and agencies
  • Meeting with Finance and providing monthly budget updates to MALT to support responsible budget management by MALT members
  • Accessing MSL CRM (e.g. Veeva) to update fields, access data and generate analytical reports
  • Scheduling support for Sales Training requests for MSLs
  • Support development of framework for Medical Society engagement across functions to ensure strong collaboration and thoughtful use of budgetary support
  • Coordination of Medical Affairs attendees at scientific congresses
  • Identification and implementation of process improvement initiatives
  • Tracks and reports department deliverables (KPIs, metrics, goals)
  • Establish and maintain Radius (shared) folder structure to support Medical Affairs.

• Monthly Medical Affairs reporting:
  • Prepare and distribute monthly MA reports, ad hoc reports, summaries, or analyses as required
  • Providing IIS/Grant/Project updates and metrics for report
  • Support collection and analysis of Field Medical (MSL) metrics for report

• Investigator Initiated Study (IIS) Program:
  • Manage IIS Review Committee Meeting activities: Track and review all new proposals/protocols received, conduct committee meetings, collaborate with Medical Director pre-post mtgs, route through multi-step review process including but not limited to detailed meeting minutes, requests for additional info, post meeting approvals, development and coordination of communications with internal and external stake holders/Investigators in compliant manner.
  • IIS Contracting and Fair Market Value (FMV) Process: Work with legal to ensure contracts reflect project accordingly. Review budget, perform compliance checks (OIG, FDA Debarment List, etc.), document/archive, ensure consistency and accuracy in FMV.
  • Study start-up, maintenance, tracking, close-out: For all approved grants across products, work with investigators to ensure start-up documents received, reviewed and accurate prior to providing study drug or payments. Track milestones & process payments, provide arcuate accruals to Finance. Ensure accurate & up to date budget tracking which feeds into periodic corporate budget reforecasting and annual projections for program budgets.
  • Drug/material planning/forecasting, shipping, tracking, expiry: Ensure drug supply needs accurately captured and provided to manager for planning of investigational products with supply chain.
  • Routinely and consistently track study timelines and all publications (planned & actual). Ensure draft publications are processed through review and timely feedback provided to investigator.
  • Ensure compliance with SOPs across all activities, identification and appropriate escalation of issues/risks.
  • Responsible for 100% Audit Readiness

• Educational Grants Program:
  • Scheduling Grants Review Committee meetings, setting agenda, recording minutes
  • Follow-up communications related to Grants Review Committee decisions to KOLs, Medical Affairs colleagues
  • Track and manage Educational Grants Program budget

Experience and Qualifications:

• Bachelor's Degree, preferably in a health-related field (Biology, Life science, Pharmacy); advanced degree or pharm D in a health related field (Biology, Life science, Pharmacy) preferred
• Strong understanding of Medical Affairs function and processes with 3 years of experience within Medical Affairs preferred
• Proficient in computer systems across a variety of software, particularly Microsoft Office suite (Word, Excel, Outlook, SharePoint, Projects, Teams and PowerPoint)
• Strong working knowledge of Veeva systems and capabilities as applied to Medical Affairs
• PMP certification preferred
• Proven project management expertise
• Excellent interpersonal and communication skills with a positive mindset
• Strong team spirit with agility, intellectual curiosity, ability to rapidly work independently and an ability to find solutions to operational problems

PM11

PI143501198