Principal/Senior Medical Writer – Clinical Document Writing

This is a fully remote position, open to applicants in United Kingdom, +4 more states.

📋 Description

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

• Manage medical writing tasks related to individual studies and facilitate coordination across various departments.

• Direct the resolution of client feedback.

• Prepare clinical and regulatory documents such as protocols, clinical study reports, patient narratives, investigator brochures, informed consents, plain language summaries, safety reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, manuscripts, abstracts, posters, and presentations.

• Ensure compliance with ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style guides.

• Organize quality and editorial reviews.

• Manage source documentation effectively.

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

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

• Collaborate 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 suggest solutions, escalating when necessary.

• Offer technical support, training, and consultation.

• Contribute to internal materials, presentations, processes, standard practices, and capabilities.

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

• Develop knowledge in industry topics and regulatory requirements that influence medical writing.

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

• Complete necessary administrative tasks and other assigned responsibilities.

⛳️ Requirements

• Demonstrated strong experience in writing clinical documents.

• Ability to present scientific information clearly and accurately.

• Capability to manage medical writing tasks with minimal oversight.

• Familiarity with regulatory standards, including ICH E3 guidelines.

• Ability to adhere to company SOPs, client standards, approved templates, authorship requirements, and style and formatting guidelines.

• Skill in coordinating quality and editorial reviews.

• Proficiency in reviewing statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency.

• Ability to work collaboratively with clients and cross-functional teams in data management, biostatistics, regulatory affairs, and medical affairs.

• Experience in conducting online clinical literature searches and complying with copyright regulations.

• Proficiency in providing technical support, training, and consultation.

• Ability to mentor and lead less experienced medical writers on intricate projects.

• Knowledge of industry topics and regulatory requirements impacting medical writing.

• Capability to work within budgeted hours and communicate project status and changes.

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

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and involved line management.

• Training in technical and therapeutic areas.

• Peer recognition and total rewards program.

• An inclusive culture.

• Extensive resources, including emerging technologies, data, science, and knowledge sharing.

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