Senior Medical Writer – Clinical Document Writing

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

📋 Description

• Oversee the accurate and clear completion of medical writing deliverables.

• Manage medical writing tasks for specific studies with minimal oversight.

• Coordinate medical writing efforts within various departments and across teams.

• Facilitate the resolution of client feedback and comments.

• Prepare 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.

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

• Organize quality and editorial reviews and manage source documentation effectively.

• Lead team document reviews and assess documents as necessary.

• Serve as a peer reviewer for internal teams.

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

• Build strong working relationships with clients and collaborate with data management, biostatistics, regulatory affairs, and medical affairs teams.

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

• Identify issues and propose constructive solutions, escalating when necessary.

• Offer technical support, training, and consultation to team members.

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

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

• Develop in-depth knowledge of industry topics and regulatory requirements.

• Monitor project budgets and update medical writing leadership on status and changes.

• Complete necessary administrative tasks as required.

• Undertake other assigned work-related duties.

⛳️ Requirements

• Experience in clinical document writing, including protocols, clinical study reports (CSRs), and investigator brochures (IBs).

• Proven ability to deliver medical writing outputs clearly and accurately.

• Skilled in managing medical writing activities for specific studies.

• Familiarity with ICH E3 guidelines and regulatory standards.

• Knowledge of company SOPs, client standards, templates, authorship requirements, and style and formatting guides.

• Experience in coordinating quality and editorial reviews.

• Ability to assess statistical analysis plans and specifications for tables, figures, and listings.

• Proficient in conducting online clinical literature searches while following copyright requirements.

• Capability to provide technical support, training, and consultation.

• Experience in mentoring and leading less experienced medical writers on complex projects.

• Extensive knowledge of industry topics and regulatory guidelines that impact medical writing.

• Ability to manage tasks within budgeted hours and communicate status updates and changes effectively.

• Willingness to travel minimally (less than 25%).

• Equivalent experience, skills, and/or education will also be considered.

🏝️ Benefits

• Career development and progression opportunities.

• Supportive and engaged line management.

• Technical and therapeutic area training provided.

• Peer recognition and a comprehensive total rewards program.

• An inclusive company culture.

• Company car or car allowance offered.

• Medical, Dental, and Vision health benefits available.

• Company matching for 401k contributions.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Opportunity to earn commissions/bonuses based on company and individual performance.

• Flexible paid time off (PTO) and sick leave.