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’s life-sciences therapy development programs. Interpreting scientific and statistical information under ICH guidelines.
Responsibilities
- Independently plan and prepare a range of regulatory documents and medical communications supporting all phases of product development.
- Organize, analyze, interpret, and present scientific and statistical information in accordance with ICH and 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 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 this minimum requirement, as determined on a case-by-case basis.
- 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 is essential, including advanced Microsoft Word proficiency.
Benefits
- Remote working
- Flexible time off
- Paid holidays
- Medical insurance
- Tuition reimbursement
- Retirement plans
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