At a Glance
- Tasks: Plan and prepare regulatory documents and medical communications for product development.
- Company: Join Veristat, a global leader in accelerating life-changing therapies.
- Benefits: Enjoy remote work, flexible time off, and tuition reimbursement.
- Other info: Inclusive culture with a focus on career growth and development.
- Why this job: Make a real impact in healthcare while working with a diverse team.
- Qualifications: Bachelor's degree and 7 years of medical writing experience required.
The predicted salary is between 98550 - 120450 $ per year.
Principal Medical Writer
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 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 Principal Medical Writer works under the direction of Medical Writing management and collaborates with cross-functional internal and external document production teams.
Job Description
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 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 Principal Medical Writer works under the direction of Medical Writing management and collaborates with cross-functional internal and external document production teams.
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!
What We Offer
• Benefits vary by location and may include
- 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.
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.
Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.
Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Principal Medical Writer employer: Veristat
Veristat is an exceptional employer that fosters a collaborative and inclusive work environment, allowing employees to thrive in their roles while making a significant impact in the regulatory affairs landscape. With a focus on professional growth and development, team members benefit from flexible working arrangements and the opportunity to engage with diverse client projects, all while contributing to meaningful advancements in healthcare. Located in a global setting, Veristat offers a unique chance to work alongside industry leaders and shape the future of regulatory strategy.
