Senior Medical Writer – FSP Team

• Lead the clear and accurate completion of medical writing deliverables
• Manage medical writing activities for individual studies with minimal supervision
• Coordinate medical writing activities within and across departments
• Lead resolution of client comments
• Complete clinical study protocols, protocol amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, abstracts, posters, and presentations
• Adhere to ICH E3 guidelines, regulatory standards, standard operating procedures, client standards, approved templates, authorship requirements, and style and formatting guides
• Coordinate quality and editorial reviews
• Manage source documentation appropriately
• Lead team document reviews and review documents as needed
• Act as a peer reviewer for scientific content, clarity, consistency, and format
• Review statistical analysis plans and table/figure/listing specifications
• Provide feedback on statistical outputs and document needs
• Collaborate with clients and data management, biostatistics, regulatory affairs, and medical affairs teams
• Perform online clinical literature searches and comply with copyright requirements
• Identify and propose solutions, escalating issues as appropriate
• Provide technical support, training, and consultation
• Contribute to internal materials, presentations, processes, standard practices, and capabilities
• Mentor and lead less experienced medical writers on complex projects
• Develop expertise in industry topics and regulatory requirements
• Work within budgeted hours and communicate status and changes to medical writing leadership
• Complete required administrative tasks
• Perform other assigned duties
• Minimal travel may be required (less than 25%)

• 3–5 years of relevant experience in science, technical, or medical writing
• Veeva Vault — MUST HAVE
• FSP or CRO experience preferred
• Comfortable using technology
• Experience in the biopharmaceutical, device, or contract research organization industry required
• Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required
• Experience writing relevant document types required
• Extensive knowledge of English grammar
• Ability to communicate clearly
• Strong familiarity with AMA Manual of Style
• Candidates may be based anywhere in EMEA except Switzerland, Germany, and France
• Equivalent experience, skills, and/or education will also be considered

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition
• Total rewards program
• Inclusive culture
• Minimal travel (less than 25%)