Principal Medical Writer - Clinical Focus
About the role
The Principal Medical Writer independently plans and prepares a range of regulatory documents and medical communications to support all phases of product development. Responsibilities include 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 Principal Medical Writer works under the direction of Medical Writing management and collaborates with cross-functional internal and external document production teams.
Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide:
- 105+ approved therapies for marketing applications prepared by Veristat
- 480+ oncology projects in the past 5 years
- 350+ rare disease projects delivered in the past 5 years
- Flexible, inclusive culture — 70% remote workforce, 66% women-led 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 proficiency.
Benefits
- Remote working
- Flexible time off
- Paid holidays
- Medical insurance
- Tuition reimbursement
- Retirement plans
Pay
The estimated hiring range for this role is $142K–153K USD plus applicable bonus. This range is specific to the US and will vary for other regions based on local market data. Final salary is determined by skills, experience, licensure, certifications, education, location, and dynamic market factors.