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
- Medical Writer developing clinical protocols and regulatory documents for Syneos Health’s life sciences clients. Partnering with Clinical Scientists across oncology, hematology, and cell therapy studies.
Responsibilities
- Partner closely with Clinical Scientists on protocols and protocol amendments
- Lead clear and accurate completion of medical writing deliverables
- Manage medical writing activities for individual studies with minimal supervision
- Coordinate medical writing activities across departments
- Lead resolution of client comments
- Write 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
- Follow ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style guides
- Coordinate quality and editorial reviews and manage source documentation
- Lead team document reviews and act as an internal peer reviewer
- Review statistical analysis plans and table/figure/listing specifications
- Collaborate with clients and data management, biostatistics, regulatory affairs, and medical affairs teams
- Perform online clinical literature searches and comply with copyright requirements
- Identify and resolve issues, escalating as appropriate
- Provide technical support, training, and consultation
- Mentor and lead less experienced medical writers
- Develop expertise in industry topics and regulatory requirements
- Monitor budgeted hours and communicate status and changes to medical writing leadership
- Complete required administrative tasks and other assigned duties
Requirements
- 3-5 years of relevant experience in medical writing, with proven experience in Protocol writing
- Experience working in the biopharmaceutical, device, or contract research organization industry required
- Experience with late development
- Experience with Oncology/Hematology/Cell therapy
- Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required
- Experience writing relevant document types required
- Experience in working with Veeva/CARA
- 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
- Total rewards program
- Inclusive culture
- Minimal travel (less than 25%)
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
No Education Requirement
Location requirements
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