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 II developing clinical protocols and regulatory documents for Syneos Health, a life sciences services organization. Leading medical writing deliverables across clinical studies and regulatory submissions.
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 within and 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 standard operating procedures, client standards, approved templates, authorship requirements, and style guides
- Coordinate quality and editorial reviews
- Manage source documentation appropriately
- Lead team document reviews and review documents as needed
- Act as peer reviewer for internal teams
- Review statistical analysis plans and table/figure/listing specifications
- Provide feedback to define statistical outputs and document needs
- Build working relationships 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 propose solutions, escalating issues as appropriate
- Provide technical support, training, and consultation
- Contribute to internal materials, presentations, processes, standards, and capabilities
- Mentor and lead less experienced medical writers on complex projects
- Develop expertise in industry topics and regulatory requirements
- Work within budgeted hours and communicate status and changes to medical writing leadership
- Complete administrative tasks within specified timeframes
- Perform 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
- Experience with late development
- Experience with Oncology, Hematology, Cell therapy, or Neurology
- Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices
- Experience writing relevant document types
- Experience working with Veeva/CARA
- Extensive knowledge of English grammar and ability to communicate clearly
- Strong familiarity with AMA Manual of Style
- Remote-based location must be Portugal, UK, or Canada
- Equivalent experience, skills, and/or education may be considered
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Minimal travel required (less than 25%)
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
No Education Requirement
Location requirements
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