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
Life Sciences / Pharmaceutical / Regulatory Affairs
Required skills
Program management, budgeting, forecasting, resource management, client relationship management, risk escalation, quality compliance, contract negotiation, proposal development, mentoring
Preferred skills
Advanced degree, pharmaceutical/CRO industry experience, medical writing certifications (AMWA, EMWA, RAC), in-depth knowledge of preclinical/therapeutic/regulatory specialties
Technologies
None explicitly stated
Responsibilities
Develop project timelines, standards, budgets, and forecasts; serve as liaison for contract modifications; assist in business development and proposal presentations; 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 clinical documents
Seniority
Senior, hands-on IC with leadership responsibilities
