FSP Program Manager Medical Writing EMEA
Core
Lead client programs in regulatory medical writing, ensuring operational excellence, timely delivery, and quality of multiple program documents for pharmaceutical and biotech clients.
Role type
Senior Program Manager (Regulatory Medical Writing)
Builds
Regulatory medical writing programs and documents for top pharmaceutical companies and biotechs
Domain
Pharmaceutical / Biotechnology / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Program management, budgeting, forecasting, resource management, client relationship management, risk escalation, contract negotiation, proposal development, quality compliance, mentoring
Preferred skills
Medical writing (AMWA, EMWA, RAC), pharmaceutical/CRO industry experience, advanced degree in scientific discipline, knowledge of global/regional document guidelines, specialty area expertise (preclinical, therapeutic, regulatory, submissions)
Technologies
None explicitly stated
Responsibilities
Develop project timelines, standards, budgets, and forecasts; manage client relationships and resolve issues; ensure compliance with quality processes; serve as point of contact for risk escalation; provide training for medical writers; support business development and contract negotiations
Seniority
Senior, hands-on IC with leadership responsibilities
