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.
About the role
- Senior Medical Writer leading regulatory documents for Syneos Health’s life sciences services. Producing clinical submissions, reports, and safety documentation for sponsor-dedicated programs.
Responsibilities
- Lead the clear and accurate completion of medical writing deliverables
- Manage medical writing activities for individual studies and coordinate across departments
- Lead resolution of client comments
- Complete protocols, protocol amendments, clinical study reports, patient narratives, investigator brochures, informed consents, plain language summaries, safety 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, templates, authorship requirements, and style 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 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
- Contribute to internal materials, presentations, processes, standards, and capabilities
- Mentor and lead less experienced medical writers
- Develop expertise in industry topics and regulatory requirements
- Monitor assigned project budgets and communicate status and changes
- Complete administrative tasks and other assigned duties
Requirements
- Minimum of 5 years of lead regulatory writing experience
- Lead writing experience with Phase 2 and Phase 3 studies
- Lead writer experience with protocols
- Lead writer experience with submissions
- Lead writer experience with CTD Modules 2.7.3 and 2.7.4
- Lead writer experience with Clinical Study Reports (CSRs)
- Lead writer experience with Investigator Brochures (IBs)
- Lead writer experience with Patient Narratives
- Experience with Safety Aggregate Reports is a plus
- Experience with briefing books
- Experience with Integrated Summary Efficacy (ISE) and Integrated Summary Safety (ISS)
- Strong project management skills
- Strong client experience
- Time management skills
- Process experience is a plus
- Open to candidates in the US, UK, and Canada
- 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 401(k)
- 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
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Degree requirement
No Education Requirement
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