Principal Medical Writer – Sponsor-dedicated

• Lead the clear and accurate completion of complex medical writing deliverables
• Manage medical writing activities for individual studies, including document strategy and cross-department coordination
• Lead resolution of client comments
• Write clinical study protocols, protocol amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, safety reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, abstracts, posters, and presentations
• Adhere to ICH E3 guidelines, company SOPs, client standards, templates, authorship requirements, and style guides
• Advise clients and study teams on data presentation and production strategies
• Lead document reviews and coordinate quality and editorial reviews
• Serve as expert peer reviewer and review statistical analysis plans and table/figure/listing specifications
• Collaborate with clients and data management, biostatistics, regulatory affairs, and medical affairs teams
• Perform clinical literature searches and comply with copyright requirements
• Identify and resolve issues, serve as a technical SME, and contribute to internal materials and process improvements
• Mentor and lead less experienced medical writers
• Develop expertise in industry topics and regulatory requirements and engage with industry groups
• Monitor project budgets, contribute to bid projections, negotiate timelines, and communicate status to leadership
• Represent medical writing on study teams, at conferences, meetings, and client presentations
• Complete administrative tasks and other assigned duties

• At least 6 years of relevant experience in science, technical, or medical writing
• Extensive experience working in the biopharmaceutical, device, or contract research organization industry
• Advanced understanding of FDA and ICH regulations and guidelines and/or good publication practices
• Extensive experience writing relevant document types
• Extensive knowledge of English grammar and ability to communicate clearly
• Strong familiarity with AMA Manual of Style
• Minimal travel may be required (less than 25%)

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition
• Total rewards program
• Inclusive culture