Medical Writer creating accurate scientific content for pharmaceutical, biotechnology, and medical device clients. Supporting literature reviews, MLR review, content development, and cross - functional collaboration.
About the role
- Senior medical writer developing protocols and regulatory submission documents for Syneos Health, a life sciences services organization. Collaborating with clinical, statistical, regulatory, and medical affairs teams.
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
- Follow 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 a 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 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 affecting medical writing
- Work within 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 medical writing, including proven Protocol writing experience
- Experience working in the biopharmaceutical, device, or contract research organization industry
- 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
- 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
- Minimal travel may be required (less than 25%)
- 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
- Total rewards program
- Inclusive culture
- 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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