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 effective completion of medical writing assignments.

• Manage medical writing tasks for individual studies and coordinate actions across various departments.

• Facilitate the resolution of client feedback.

• Produce clinical study protocols, clinical study reports, patient narratives, annual reports, investigator brochures, informed consent documents, plain language summaries, safety reports, clinical development plans, regulatory submissions, journal manuscripts, abstracts, posters, and presentations.

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

• Organize quality and editorial reviews while managing source documentation.

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

• Assess statistical analysis plans and table/figure/listing specifications.

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

• Conduct online clinical literature searches while complying with copyright regulations.

• Identify and address issues, provide technical support and training, and contribute to the improvement of internal materials and processes.

• Mentor and guide less experienced medical writers on intricate projects.

• Cultivate expertise in industry topics and regulatory requirements.

• Operate within project budgets and communicate updates and changes to medical writing leadership.

• Complete necessary administrative tasks and other assigned responsibilities.

⛳️ Requirements

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

• Required experience in the biopharmaceutical, device, or contract research organization sectors.

• Strong understanding of FDA and ICH regulations, along with other regulatory guidelines and/or good publication practices is essential.

• Experience in writing the necessary document types is required.

• Extensive knowledge of English grammar and the ability to communicate effectively.

• Strong familiarity with the AMA Manual of Style.

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

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• Inclusive workplace culture.

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