Senior Medical Writer – FSP Team

This is a fully remote position, open to applicants in Spain, +1 more country.

📋 Description

• Oversee the precise and thorough execution of medical writing deliverables.

• Handle medical writing tasks for specific studies with limited oversight.

• Facilitate medical writing efforts both internally and across various departments.

• Lead the resolution of client feedback.

• Prepare 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.

• Comply with ICH E3 guidelines, regulatory standards, standard operating procedures, client expectations, approved templates, authorship requirements, and style and formatting manuals.

• Organize quality and editorial assessments.

• Appropriately manage source documentation.

• Guide team document evaluations and review documents as necessary.

• Serve as a peer reviewer for scientific content, clarity, consistency, and format.

• Examine statistical analysis plans and specifications for tables, figures, and listings.

• Offer feedback on statistical outputs and documentation needs.

• Collaborate with clients and teams in data management, biostatistics, regulatory affairs, and medical affairs.

• Conduct online clinical literature searches while adhering to copyright regulations.

• Identify issues and propose solutions, escalating concerns as necessary.

• Provide technical support, training, and consulting.

• Contribute to internal materials, presentations, processes, standardized practices, and capabilities.

• Mentor and guide junior medical writers on intricate projects.

• Develop expertise in industry subjects and regulatory requirements.

• Operate within budgeted hours and communicate status updates and changes to medical writing leadership.

• Complete necessary administrative tasks.

• Undertake other assigned responsibilities.

• Occasional travel may be required (less than 25%).

⛳️ Requirements

• 3–5 years of relevant experience in scientific, technical, or medical writing.

• Proficiency in Veeva Vault — MUST HAVE.

• Experience with FSP or CRO is preferred.

• Comfortable utilizing technology.

• Experience in the biopharmaceutical, device, or contract research organization sectors is essential.

• Strong knowledge of FDA and ICH regulations, additional regulatory guidelines, and/or good publication practices is necessary.

• Experience in writing relevant document types is required.

• Extensive understanding of English grammar.

• Clear communication skills are essential.

• Strong familiarity with the AMA Manual of Style.

• Candidates can be located anywhere in EMEA except Switzerland, Germany, and France.

• Equivalent experience, skills, and/or education will also be considered.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition.

• Total rewards program.

• Inclusive culture.

• Minimal travel requirements (less than 25%).