Principal Medical Writer – Publications

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

📋 Description

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

• Manage medical writing tasks for specific studies, which includes document strategy and interdepartmental coordination.

• Lead the resolution of feedback from clients.

• Produce clinical, regulatory, and publication documents such as protocols, reports, submissions, manuscripts, abstracts, posters, and presentations.

• Ensure adherence to regulatory requirements, company SOPs, client standards, templates, authorship expectations, and formatting guidelines.

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

• Facilitate team document reviews and assess documents for technical errors.

• Coordinate quality and editorial reviews while managing source documentation.

• Act as an expert peer reviewer.

• Evaluate statistical analysis plans and specifications for tables, figures, and listings.

• Foster relationships with clients and cross-functional teams.

• Conduct online searches of clinical literature while adhering to copyright regulations.

• Identify and propose effective solutions, escalating issues as necessary.

• Serve as a vital technical subject matter expert and contribute to internal materials, presentations, processes, standards, and capabilities.

• Mentor and guide less experienced medical writers.

• Acquire knowledge in industry-related topics and regulatory guidelines while engaging with industry groups.

• Monitor project budgets and assist with bid forecasts.

• Communicate project status and changes, negotiating timelines and deliverables.

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

• Complete necessary administrative tasks and other assigned responsibilities.

⛳️ Requirements

• Principal-level expertise in medical writing.

• Proven experience in delivering complex medical writing products with minimal oversight.

• Familiarity with regulatory standards, specifically ICH E3 guidelines.

• Capability to work with company SOPs, client standards, approved templates, authorship requirements, and style and formatting guidelines.

• Experience with clinical study protocols and 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.

• Ability to counsel clients and study teams on data presentation and production strategies.

• Experience in leading document reviews and coordinating quality and editorial assessments.

• Proficiency in reviewing statistical analysis plans and specifications for tables, figures, and listings.

• Experience collaborating with data management, biostatistics, regulatory affairs, medical affairs, clients, and study teams.

• Ability to conduct online searches of clinical literature and adhere to copyright laws.

• Skill in identifying, proposing, and escalating solutions to challenges.

• Expertise in industry topics and regulatory standards pertinent to medical writing.

• Competence in managing budgets, timelines, and deliverables.

• Ability to mentor and guide less experienced medical writers.

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

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

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• An inclusive workplace culture.

• Access to extensive resources, including emerging technologies, data, science, and knowledge sharing.

• Collaboration with diverse teams of experts.

• Various career paths and employment opportunities.

• Minimal travel required (less than 25%).