Principal Medical Writer

Veristat; United States; Remote; USD 130,000 - 190,000; Full time

Benefits offered by this job

Remote working

Flexible time off

Paid holidays

Medical insurance

Tuition reimbursement

Retirement plans

Job summary

Veristat, a global CRO, seeks a Principal Medical Writer to independently plan and prepare regulatory documents across product development, ensuring compliance with ICH guidelines and company standards.

You will collaborate with cross-functional teams and external vendors to organize, interpret, and present scientific data with strong English writing and meticulous attention to detail.

Qualifications

• Bachelor’s degree required; science-related field preferred.
• 7+ years of medical writing experience in CRO/pharma/biotech settings.
• Advanced knowledge of ICH and related regulatory guidelines.
• Excellent written English and keen attention to detail.
• Strong interpersonal and communication skills.
• MS Office proficiency, especially Word.

Responsibilities

• Independently plans and prepares regulatory documents and medical communications.
• Organizes, analyzes, interprets, and presents scientific data per guidelines.
• Collaborates with cross-functional internal and external document production teams.

Skills

Regulatory writing

Medical writing

ICH guidelines

English writing

Interpersonal skills

Education

Bachelor’s degree

Job description

Job Description:

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.

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 Veristar Talent Acquisition team; Veristar does not utilize an automated decision-making process.

Veristar is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.