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
- Medical writer leading clinical, regulatory, and scientific documents for Syneos Health, a life sciences services organization. Collaborating with biopharmaceutical clients and cross-functional clinical teams.
Responsibilities
- Lead the clear and accurate completion of medical writing deliverables
- Manage medical writing activities associated with individual studies
- Coordinate medical writing activities within and across departments with minimal supervision
- Lead resolution of client comments
- Complete clinical, regulatory, safety, publication, and submission documents
- Adhere to regulatory standards, ICH E3 guidelines, company SOPs, client standards, templates, authorship requirements, and style guides
- Coordinate quality and editorial reviews
- Manage source documentation appropriately
- Lead team document reviews and act as a peer reviewer
- Review statistical analysis plans and table/figure/listing specifications
- Interact 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 to resolve issues
- 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 required administrative tasks and other assigned duties
Requirements
- 3–5 years of relevant experience in science, technical, or medical writing
- Experience in the biopharmaceutical, medical device, or contract research organization industry required
- Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices
- Experience writing relevant document types
- Extensive knowledge of English grammar
- Ability to communicate clearly
- Strong familiarity with AMA Manual of Style
- Ability to work within budgeted hours and specified timeframes
- 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
- Minimal travel may be required (less than 25%)
- Comprehensive resources including emerging technologies, data, science and knowledge sharing
- Career paths and employment opportunities
- Collaborate with passionate problem solvers
- Partner with the most diverse team of experts in the industry
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
No Education Requirement
Location requirements
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