Senior Medical Writer – Sponsor-dedicated

This is a fully remote position, open to applicants in United Kingdom, +3 more countries.

📋 Description

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

• Manage medical writing tasks for individual studies with little supervision.

• Coordinate medical writing efforts within and between 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.

• Adhere to ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style and formatting guidelines.

• Coordinate quality and editorial reviews while managing source documentation.

• Lead team document reviews and serve as a peer reviewer.

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

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

• Conduct online searches of clinical literature while ensuring compliance with copyright regulations.

• Identify and address issues, escalating them as necessary.

• Provide technical support, training, and consultations.

• Contribute to internal materials, presentations, processes, standards, and capabilities.

• Mentor and guide less experienced medical writers.

• Cultivate expertise in industry topics and regulatory requirements.

• Monitor project budgets and communicate updates and changes.

• Complete necessary administrative tasks and other assigned responsibilities.

⛳️ Requirements

• 3-5 years of pertinent experience in science, technical, or medical writing.

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

• Solid understanding of FDA and ICH regulations, additional regulatory guidelines, and/or good publication practices.

• Proven experience in composing relevant document types.

• Extensive knowledge of English grammar and strong communication skills.

• Strong familiarity with the AMA Manual of Style.

• Ability to work within budgeted hours and effectively communicate status and changes to medical writing leadership.

• Equivalent experience, skills, and/or education will also be taken into account.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management team.

• Training in technical and therapeutic areas.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• A culture that values inclusivity.

• Minimal travel may be necessary (less than 25%).