Reports to: Director, Medical AffairsLocation: Plymouth Meeting, PA (Hybrid) or RemotePosition Summary:The Senior Manager, Medical Affairs Operations serves as the operational and project-management backbone of the medical affairs function-ensuring initiatives are executed efficiently. This individual manages core processes and projects, connects internal teams with external partners, and partners cross-functionally to advance the medical strategy, providing the day-to-day coordination that keeps stakeholders, priorities, and deliverables aligned and on track.
Specific Duties: - Plan, coordinate, and manage the logistics of medical affairs and cross-functional educational initiatives.
- Project-manage internal and external partners and vendors to support medical affairs tactical execution. Serve as a centralized point of contact to coordinate workflows, timelines, and deliverables.
- Partner with Scientific Communications, to manage scientific communications and publication timelines across multiple stakeholders to ensure deadlines are met for all planned congress submissions and publications.
- Coordinate Medical Affairs congress and conference activities, including conference and session coverage, booth-coverage scheduling, medical booth planning and shipment logistics, conference insights reporting, and maintaining the master conference list. Collaborate with cross-functional partners while maintaining appropriate separation from commercial activities.
- Serve as the contracting point person for the medical organization, partnering with Legal to streamline and accelerate contract execution.
- Provide updates that keep medical teams and cross-functional partners, including Marketing, Market Access, Government Affairs, and Commercial, abreast of medical affairs deliverable progress, resources, and key priorities, so teams can leverage data and evidence where appropriate.
- Coordinate intake, review, and tracking of investigator-initiated studies (IIS), medical and educational grants, and sponsorship requests in partnership with the appropriate review committees.
- Manage the Medical Affairs website, updating it with new data, publications, and conference information to ensure timely, accurate, and accessible content.
- Track, reconcile, and report on Medical Affairs budgets, spend, contracts, and invoices in partnership with Medical Affairs leads. Continuously improve medical affairs processes for efficiency.
- Build collaborative relationships and work across Clinical Development, Field Medical Affairs, Scientific Communications, Medical Information, HEOR, Regulatory, Pharmacovigilance/Safety, Commercial, Market Access, Patient Support, Legal, and Compliance to ensure alignment and operational excellence.
- Provide operational support to Pharmacovigilance business partners to ensure compliance with regulatory requirements, SDEAs, and SOPs.
- Identify and implement AI and automation solutions to streamline processes and enhance operational efficiency across Medical Affairs and Pharmacovigilance functions.
- Take on additional Medical Affairs projects and initiatives as assigned.
Skills: - Strong project problem-solving and management skills with demonstrated ability to manage multiple concurrent priorities in a dynamic, fast-paced environment.
- Prior experience with budget management, vendor contracting, and cross-functional project coordination required; experience in specialty pharmaceuticals or CNS/addiction medicine a plus.
- Working knowledge of pharmaceutical industry compliance requirements, including OIG guidelines, PhRMA Code, and regulations governing Medical Affairs and Pharmacovigilance activities.
- Excellent verbal and written communication skills with the ability to engage and build relationships across functions, including with senior leadership and external stakeholders.
- Proficiency in AI tools and emerging technologies, with experience applying them to optimize workflows and support data-driven decision-making.
- Travel up to 20% of the time.
Education/Experience: - Bachelor's degree, healthcare, business, communications, or related operations within pharmaceuticals, biotech, or healthcare.
- 5+ years' Experience working with cross-functional teams in a specialty pharmaceutical company; prior exposure to CNS or addiction medicine therapeutic areas is a plus
- Proficiency with Medical Affairs operational tools and systems (e.g., Veeva, CRM platforms, publication management tools); experience with budget management software a plus.
