Principal Medical Writer – Sponsor-dedicated

This is a fully remote position, open to applicants in Poland, +5 more countries.

📋 Description

• Oversee the precise and thorough completion of intricate medical writing projects.

• Coordinate medical writing efforts for individual studies, encompassing document strategies and interdepartmental collaboration.

• Lead the resolution of client feedback.

• Draft clinical study protocols, protocol amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consent documents, plain language summaries, safety 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 SOPs, client standards, templates, authorship requirements, and style guides.

• Provide guidance to clients and study teams on data presentation and production methodologies.

• Direct document reviews and facilitate quality and editorial evaluations.

• Act as an expert peer reviewer while assessing statistical analysis plans and table/figure/listing specifications.

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

• Conduct clinical literature searches while adhering to copyright regulations.

• Identify and address challenges, serve as a technical Subject Matter Expert (SME), and contribute to internal documentation and process enhancements.

• Mentor and guide junior medical writers.

• Cultivate expertise in industry topics and regulatory standards while engaging with industry organizations.

• Monitor project budgets, assist in bid projections, negotiate timelines, and update leadership on project status.

• Represent medical writing on study teams, at conferences, meetings, and during client presentations.

• Complete administrative responsibilities and other assigned tasks.

⛳️ Requirements

• A minimum of 6 years of relevant experience in scientific, technical, or medical writing.

• Significant experience within the biopharmaceutical, device, or contract research organization sectors.

• In-depth knowledge of FDA and ICH regulations and guidelines, as well as good publication practices.

• Extensive experience in producing relevant document types.

• Strong command of English grammar and the ability to communicate effectively.

• Familiarity with the AMA Manual of Style.

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

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• An inclusive workplace culture.