Senior Medical Writer leading regulatory documents for Syneos Health’s life sciences services. Producing clinical submissions, reports, and safety documentation for sponsor - dedicated programs.
About the role
- Senior Medical Writer producing clinical and regulatory documents for Syneos Health, a life sciences services organization. Leading cross-functional medical writing, reviews, and client deliverables.
Responsibilities
- Lead clear and accurate completion of medical writing deliverables
- Manage medical writing activities associated with individual studies and coordinate activities across departments
- Lead resolution of client comments
- Complete 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
- Adhere to ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style and formatting guides
- Coordinate quality and editorial reviews and manage source documentation
- Lead team document reviews and act as peer reviewer
- Review statistical analysis plans and table/figure/listing specifications
- Build working relationships with clients and cross-functional teams in data management, biostatistics, regulatory affairs, and medical affairs
- Perform online clinical literature searches and comply with copyright requirements
- Identify and propose solutions, escalating issues as appropriate
- Provide technical support, training, and consultation
- Mentor and lead less experienced medical writers on complex projects
- Develop expertise in industry topics and regulatory requirements
- Monitor budgeted hours and communicate status and changes to medical writing leadership
- Complete administrative tasks and other assigned duties
Requirements
- 3-5 years of relevant experience in science, technical, or medical writing
- Experience working in the biopharmaceutical, device, or contract research organization industry required
- Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required
- Experience writing relevant document types required
- Extensive knowledge of English grammar and ability to communicate clearly
- Strong familiarity with AMA Manual of Style
- Minimal travel may be required (less than 25%)
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Inclusive culture
- Company car or car allowance
- Medical, Dental and Vision health benefits
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO)
- Sick time
- Reasonable accommodations, when appropriate
Job title
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Experience level
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Degree requirement
No Education Requirement
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