Principal Medical Writer - Nonclinical 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 Harmonization (ICH) and other regulatory guidelines, as well as company document standards. The role operates under Medical Writing management and collaborates with cross-functional internal and external document production teams.

Impact at Veristat

• Join a global team with over 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; MS or PhD preferred.
• 7+ years of regulatory writing experience or equivalent experience with nonclinical sections of the CTD, such as:
  • 2.4 Nonclinical Overview
  • 2.6 Nonclinical Summaries
  • Pharmacology, pharmacokinetic (ADME), or toxicology reports
• Understand regulatory authority guidelines and requirements to lead internal project teams and anticipate the effects of writing practice conventions on the final product when seeking health authority approval/acceptance.
• Experience in the development of submission-level documents.

Skills & Abilities

• Intermediate proficiency with Microsoft Word (editing tools, creating and modifying tables, inserting figures) and document management techniques.
• Strong understanding of the document creation process and the drug development lifecycle.
• Able to synthesize data across multiple sources to create summary reports.
• Expertise in providing subject matter guidance for quality document preparation, review, accurate comment resolution/incorporation, and finalization.
• Ability to own submission-level sections (e.g., nonclinical section [Module 2.6]), ensuring clarity of purpose and leading teams toward common goals within timeline and budget on complex projects.
• Demonstrated understanding of communication best practices and coaching others on communication implications of decision-making.
• Ability to develop professional client relationships to further business objectives and maintain industry knowledge.
• Skill in identifying and institutionalizing effective work practices to ensure performance consistency.
• Problem-solving ability, particularly in sensitive or high-pressure situations.
• Broad experience and technical expertise across multiple therapy areas, integrating knowledge to deliver business success and transfer skills across the organization.

Benefits

• Remote working options.
• Flexible time off.
• Paid holidays.
• Medical insurance.
• Tuition reimbursement.
• Retirement plans.

Pay

The estimated hiring range for this role is $132K to $151K plus applicable bonus. This range is specific to the US and may vary for other regions based on local market data. Final salary is determined by factors including skills, experience, licensure, certifications, education, location, and dynamic market conditions.