Senior Medical Writer

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

📋 Description

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

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

• Lead the resolution of client feedback.

• Create clinical study protocols, protocol 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.

• Implement regulatory standards, company SOPs, client specifications, approved templates, authorship requirements, and style/formatting guidelines.

• Organize quality and editorial reviews.

• Lead team document evaluations and review documents as necessary.

• Serve as a peer reviewer for internal teams.

• 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 and suggest solutions for issues, escalating as necessary.

• Offer technical support, training, and consultation.

• Contribute to internal materials, presentations, processes, standards, and capabilities.

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

• Develop knowledge in industry topics and regulatory requirements.

• Monitor project budgets and communicate status updates and changes to medical writing leadership.

• Complete necessary administrative tasks.

• Carry out other assigned work-related duties.

⛳️ Requirements

• Extensive experience and expertise in medical writing and drug development.

• Capacity to lead precise and accurate medical writing deliverables with minimal supervision.

• Familiarity with regulatory standards, including ICH E3 guidelines.

• Ability to work with company/client SOPs, standards, templates, authorship requirements, and style/formatting guides.

• Experience in coordinating quality and editorial reviews and managing source documentation.

• Proficiency in peer reviewing scientific content for clarity, consistency, and format.

• Capability to review statistical analysis plans and table/figure/listing specifications.

• Skills in clinical literature searches and understanding of copyright requirements.

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

• Capacity to mentor less experienced medical writers.

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

• Ability to operate within budgeted hours and complete administrative tasks punctually.

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

• Minimal 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 and a comprehensive rewards program.

• An inclusive culture.

• Company car or car allowance.

• Medical, Dental, and Vision health benefits.

• Company-matched 401k.

• 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).

• Sick leave.