Sponsor Dedicated Protocol Medical Writer II

This is a fully remote position, open to applicants in United Kingdom, +2 more countries.

📋 Description

• Collaborate closely with Clinical Scientists on protocols and protocol amendments.

• Oversee the precise and effective completion of medical writing deliverables.

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

• Coordinate medical writing efforts both within and across departments.

• Facilitate 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, company standard operating procedures, client standards, approved templates, authorship requirements, and style guides.

• Organize quality and editorial reviews.

• Appropriately manage source documentation.

• Lead team document reviews and assess documents as necessary.

• Serve as a peer reviewer for internal teams.

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

• Offer feedback to clarify statistical outputs and documentation needs.

• Build productive relationships 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 matters as needed.

• Provide technical support, training, and consultation.

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

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

• Develop expertise in industry topics and regulatory standards.

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

• Complete administrative responsibilities within designated timeframes.

• Carry out other assigned duties.

⛳️ Requirements

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

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

• Experience with late-stage development.

• Background in Oncology, Hematology, Cell therapy, or Neurology.

• Strong comprehension of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices.

• Experience in writing relevant document types.

• Familiarity with Veeva/CARA.

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

• Strong familiarity with the AMA Manual of Style.

• Remote working location must be in Portugal, the UK, or Canada.

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

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and involved line management.

• Training in technical and therapeutic areas.

• Peer recognition.

• Total rewards program.

• Inclusive workplace culture.

• Minimal travel required (less than 25%).