Senior Medical Writer leading clinical regulatory and clinical document authorship for Veristat, a life - sciences consultancy accelerating therapies. Managing projects, teams, clients, and submission deliverables.
About the role
- Senior Medical Writer leading regulatory and clinical documents for Syneos Health, a life sciences services organization. Managing submissions, reviews, client coordination, and mentoring across Phase 2 and 3 studies.
Responsibilities
- Lead clear and accurate completion of medical writing deliverables and manage writing activities for individual studies
- Coordinate medical writing activities across departments and lead resolution of client comments
- Complete clinical, regulatory, safety, submission, and scientific meeting documents, including protocols, CSRs, IBs, patient narratives, aggregate reports, IND/NDA/eCTD submissions, manuscripts, abstracts, posters, and presentations
- Follow ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style guides
- Coordinate quality and editorial reviews, manage source documentation, and lead team document reviews
- Act as peer reviewer for scientific content, clarity, consistency, and formatting
- Review statistical analysis plans and table/figure/listing specifications and provide feedback on statistical outputs and document needs
- Build working relationships with clients and data management, biostatistics, regulatory affairs, and medical affairs teams
- Perform clinical literature searches and comply with copyright requirements
- Identify and escalate issues and provide technical support, training, and consultation
- Mentor and lead less experienced medical writers on complex projects
- Develop expertise in industry topics and regulatory requirements affecting medical writing
- Monitor assigned project budgets, communicate status and changes, and complete administrative tasks
- Perform other assigned duties; minimal 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, submissions, CTD Modules 2.7.3 and 2.7.4, CSRs, IBs, patient narratives, briefing books, ISE, and ISS
- Experience with Safety Aggregate Reports is a plus
- Strong project management skills
- Strong client experience
- Strong time management skills
- Process experience is a plus
- 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 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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