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
- Senior medical writer leading regulatory documents for Syneos Health’s integrated life sciences services. Preparing submissions, clinical reports, and safety materials for Phase 2 and 3 studies.
Responsibilities
- Lead clear and accurate medical writing deliverables and coordinate activities within and across departments
- Lead resolution of client comments
- Prepare 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 scientific meeting 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 review documents as needed
- Act as peer reviewer for scientific content, clarity, consistency, and formatting
- Review statistical analysis plans and table/figure/listing specifications
- Collaborate with clients and data management, biostatistics, regulatory affairs, and medical affairs teams
- Conduct 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, standard practices, 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
- Perform other assigned duties
- Travel may be required, less than 25%
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
- Lead writer experience with Briefing Books
- Lead writer experience with Integrated Summary Efficacy (ISE) and Integrated Summary Safety (ISS)
- Strong project management skills
- Strong client experience
- Strong time management skills
- Process experience is a plus
- Open to candidates in the US, UK, and Canada
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 401k
- 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
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Degree requirement
No Education Requirement
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