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
- Principal Medical Writer preparing regulatory documents and medical communications for Veristat, a clinical research organization accelerating life-changing therapies. Supporting product development through scientific analysis, ICH compliance, and cross-functional document collaboration.
Responsibilities
- Independently plan and prepare regulatory documents and medical communications supporting all phases of product development
- Organize, analyze, interpret, and present scientific and statistical information according to ICH and other regulatory guidelines
- Prepare documents in accordance with company document standards
- Work under the direction of Medical Writing management
- Collaborate with cross-functional internal and external document production teams
Requirements
- Bachelor’s degree required; science-related field preferred
- Minimum of 7 years of medical writing experience in a contract research organization or pharmaceutical/biotechnology research setting
- Other professional and/or educational experience may contribute toward the minimum experience requirement on a case-by-case basis
- Advanced knowledge of ICH and related regulatory guidelines
- Excellent written English
- Keen attention to detail
- Strong interpersonal and communication skills
- Experience with Microsoft Office Suite is essential
Benefits
- Remote working
- Flexible time off
- Paid holidays
- Medical insurance
- Tuition reimbursement
- Retirement plans
- Applicable bonus
- Inclusive culture
- Reasonable accommodations and accessible application experience
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