Senior Medical Writer
Veristat
Summary
The Senior Medical Writer independently plans and prepares a range of regulatory documents and medical communications to support all phases of product development. The primary responsibilities of the position are organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with International Council for Harmonisation (ICH) and other regulatory guidelines, and individual company document standards. The Senior Medical Writer works under the direction of Medical Writing management and collaborates with cross-functional internal and external document production teams.
Job description
What we look for
- 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, as determined on a case-by-case basis; however, a minimum of 3 years of formal medical writing experience is 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 is essential, including advanced Microsoft Word proficiency.
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.
- Minimum of 3 years of formal medical writing experience is 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 is essential, including advanced Microsoft Word proficiency.
Benefits
- Flexible culture
- Inclusive environment
Company overview
Veristat is a science-first full-service clinical research organization (CRO) and consultancy that specializes in advancing complex and novel therapies through integrated strategic planning, regulatory expertise, and clinical trial execution. With nearly 30 years of experience, the company focuses on supporting emerging, small, and mid-size biopharmaceutical companies in developing innovative treatments for challenging therapeutic areas including oncology, neurology, rare diseases, infectious diseases, and metabolic disorders. Veristat's comprehensive services span the entire drug development lifecycle, from early-phase clinical trial design and execution to regulatory submissions and post-marketing support. The company has established a strong track record in biologics, gene therapies, and cell therapies, having supported the first gene therapy approved in Europe. Operating globally with offices across North America, Europe, and Asia, Veristat employs a team of scientific experts who combine bold thinking with practical execution to help clients navigate regulatory complexities and accelerate the delivery of life-changing therapies to patients in need.