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 (clinical study reports, protocols, IBs, INDs, MAAs)
Domain
Pharmaceutical / Biotechnology / Regulatory Affairs
Required skills
Program management, budgeting, forecasting, resource management, risk escalation, contract negotiation, client relationship management, quality compliance, mentoring
Preferred skills
Medical writing (AMWA, EMWA, RAC), pharmaceutical/CRO industry experience, knowledge of global/regional document guidelines, preclinical/therapeutic/regulatory specialty knowledge
Technologies
None explicitly stated
Responsibilities
Develop project timelines, standards, budgets, and forecasts; serve as liaison for contract modifications; assist in business development and proposal development; act as point of contact for risk escalation; ensure compliance with quality processes; provide training for medical writers; serve as backup medical writer for complex documents
Seniority
Senior, hands-on IC with leadership responsibilities
