Principal Medical Writer – Publications

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Guides the precise and thorough completion of medical writing outputs.

• Oversees medical writing tasks linked to specific studies.

• Facilitates the resolution of client feedback.

• Produces a range of documents including clinical study protocols and their amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consent forms; plain language summaries; periodic safety update reports; clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; and abstracts, posters, and presentations for scientific conferences.

• Complies with established regulatory standards.

• Coordinates quality assurance and editorial reviews.

• Ensures proper management of source documentation.

• Serves as a peer reviewer for the internal team.

• Evaluates statistical analysis plans and table/figure/listing specifications for accuracy and relevance.

• Engages and fosters positive relationships with clients and colleagues.

• Conducts online searches of clinical literature.

• Identifies issues and suggests effective solutions.

• Provides technical assistance, training, and consultation to department and other company personnel.

• Guides and mentors less experienced medical writers on complex assignments.

• Cultivates in-depth knowledge on critical topics within the industry.

⛳️ Requirements

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

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

• Strong knowledge of FDA and ICH regulations, additional regulatory guidelines, and/or best practices in publication is essential.

• Proven experience in producing relevant document types is necessary.

• Comprehensive understanding of English grammar and the ability to communicate effectively.

• High familiarity with the AMA Manual of Style.

🏝️ Benefits

• We are dedicated to the growth of our employees through career development and advancement opportunities.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• A peer recognition and total rewards program.

• Commitment to fostering an inclusive workplace culture.