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 preparing regulatory documents and medical communications for Veristat’s life-sciences therapy development programs. Supporting global clinical and regulatory submissions under ICH guidelines.
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
- Ensure documents comply with ICH, other regulatory guidelines, and 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 5 years of medical writing experience in a contract research organization or pharmaceutical/biotechnology research setting
- Other professional and/or educational experience may contribute toward this minimum requirement on a case-by-case basis
- Minimum of 3 years of formal medical writing experience required
- Advanced knowledge of ICH and related regulatory guidelines
- Excellent written English and keen attention to detail
- Strong interpersonal and communication skills
- Experience with Microsoft Office Suite, including advanced Microsoft Word proficiency
Benefits
- Fully remote work arrangement
- Flexible, inclusive culture
- Equal opportunity and inclusive environment
Job title
Job type
Experience level
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Not specified
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