Principal Medical Writer
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. The primary 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.
Responsibilities
- Organize, analyze, interpret, and present scientific and statistical information in compliance with ICH and other regulatory guidelines.
- Work under the direction of Medical Writing management and 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.
- 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.
Qualifications
Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case-by-case basis.
Skills
- 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
- Benefits vary by location and may include:
- Remote working
- Flexible time off
- Paid holidays
- Medical insurance
- Tuition reimbursement
- Retirement plans
Pay
Pay varies by location and position.
Schedule
Schedule varies by location and position.
What We Offer
- Remote working
- Flexible time off
- Paid holidays
- Medical insurance
- Tuition reimbursement
- Retirement plans
What We Look For
- 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.
- 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.
Veristat
Make an Impact at Veristat! 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 Learn more about our core values here!