Principal Medical Writer leading CMC regulatory submissions for Veristat’s life - sciences clients. Authoring Modules 3 and 2.3 while guiding project teams and mentoring regulatory writers.
About the role
- Principal Medical Writer developing clinical and regulatory publications for Syneos Health’s life-sciences services. Leading complex documents, reviews, client coordination, and regulatory-compliant medical writing.
Responsibilities
- Lead clear and accurate completion of complex medical writing deliverables
- Manage medical writing activities for individual studies, including document strategy and cross-department coordination
- Lead resolution of client comments
- Write clinical study protocols, amendments, clinical study reports, patient narratives, investigator brochures, informed consents, plain language summaries, safety reports, clinical development plans, regulatory submissions, journal manuscripts, abstracts, posters, and presentations
- Ensure compliance with ICH E3 guidelines, regulatory standards, SOPs, client standards, templates, authorship requirements, and style guides
- Advise clients and study teams on data presentation and production strategies
- Lead document reviews and coordinate quality and editorial reviews
- Serve as an expert peer reviewer
- Review statistical analysis plans and table/figure/listing specifications
- Collaborate with clients and teams in data management, biostatistics, regulatory affairs, and medical affairs
- Perform online clinical literature searches and comply with copyright requirements
- Identify and resolve issues, escalating as appropriate
- Serve as a technical subject matter expert and contribute to internal materials, presentations, processes, and capabilities
- Mentor and lead less experienced medical writers
- Develop expertise in industry topics and regulatory requirements
- Engage externally with industry groups
- Monitor project budgets and contribute to bid projections
- Communicate status and negotiate timelines and deliverables with medical writing leadership
- Represent medical writing on clinical study teams, at conferences, meetings, and client presentations
- Complete administrative tasks and other assigned duties
Requirements
- At least 6 years of relevant experience in science, technical, or medical writing
- Extensive experience working in the biopharmaceutical, device, or contract research organization industry
- Advanced understanding of FDA and ICH regulations and guidelines and/or good publication practices
- Extensive experience writing relevant document types
- Extensive knowledge of English grammar and ability to communicate clearly
- Strong familiarity with AMA Manual of Style
- Experience with complex medical writing deliverables and relevant clinical/regulatory document types
- Equivalent experience, skills, and/or education will also be considered
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Inclusive culture
- Comprehensive resources including emerging technologies, data, science and knowledge sharing
- Opportunities for career paths and employment progression
- Minimal travel requirement (less than 25%)
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
No Education Requirement
Location requirements
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