Medical Affairs, Senior Associate

The Medical Affairs Operations role provides critical operational and tactical support across Medical Affairs programs, including Investigator-Sponsored Trials (ISTs) and Compassionate Use / Expanded Access Programs (EAPs). This role partners closely with cross-functional stakeholders to ensure operational excellence, regulatory compliance, and timely execution of Medical Affairs activities.

This position is ideal for a highly organized, detail-oriented professional with 2–3 years of Medical Affairs or clinical operations experience, who can manage multiple priorities and serve as a key operational resource.

• Provide day-to-day operational support for Medical Affairs–led activities related to Investigator-Sponsored Trials (ISTs).
• Support development, implementation, and maintenance of IST processes, workflows, templates, and guidance documents to ensure consistency and compliance.
• Coordinate and support IST administrative activities, including protocol development, case report forms, budgets, pharmacy manuals, and research committee coordination.
• Serve as an operational liaison for investigators and internal stakeholders, supporting FDA and regulatory correspondence for institutionally or PI-held INDs/IDEs.
• Support clinical trial registration and results reporting (e.g., Clinical Trials.gov) in compliance with regulatory requirements.
• Partner with Medical Affairs, MSLs, biostatistics, and investigators to ensure study objectives, endpoints, and data requirements are appropriately defined.
• Review regulatory submissions for completeness and compliance, identifying gaps and coordinating follow-up with investigators and study teams.
• Assist with IST budget development, Fair Market Value (FMV) assessments, negotiations, amendments, and close-out reconciliation.
• Track and report study metrics, timelines, and portfolio status to support operational oversight and planning.

• Provide operational support for Compassionate Use and Expanded Access Programs, including individual patient requests and institutional programs.
• Coordinate cross-functionally with Medical Affairs, Clinical Development, Drug Supply, Pharmacovigilance, Regulatory, Compliance, Finance, Legal, and Commercial teams to support timely review and approval of requests.
• Support preparation and maintenance of program documentation, including protocols, consent forms, SOPs, and tracking tools.
• Assist with coordination with regulatory authorities and ethics committees, as needed.
• Monitor active programs to ensure patient safety, data integrity, and timely adverse event reporting.
• Support preparation of metrics, dashboards, and summaries for internal leadership and regulatory review.
• Stay current on evolving global regulations and best practices related to compassionate use and expanded access.

• Collaborate with functional partners to support SOP development, training, and compliance across Medical Affairs.
• Support role-based training development and completion in partnership with training administrators.
• Maintain audit readiness and compliance with GCP, HIPAA, and applicable regulatory requirements.
• Assist with additional Medical Affairs Operations initiatives as needed.

• Bachelor’s degree required; advanced degree preferred.
• 2–3 years of experience in Medical Affairs, Clinical Operations, Clinical Research, or a related pharmaceutical/biotech function.
• Hands-on experience supporting clinical or Medical Affairs programs (ISTs, EAPs, or similar preferred).
• Strong understanding of regulatory and compliance requirements (GCP, FDA/EMA guidance, clinical trial reporting).
• Exceptional organizational skills with the ability to manage multiple priorities and deadlines.
• Strong communication and collaboration skills; comfortable working cross-functionally.
• Proficiency with document management, tracking tools, and reporting metrics.
• High attention to detail, proactive mindset, and ability to work independently.