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, 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; 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 an internal project team and anticipate the effects that writing practice conventions can have on the final product when seeking health authority approval/acceptance
• Experience in the development of submission-level documents

Skills

• Intermediate proficiency with Microsoft Word (editing tools, creating and modifying tables, and inserting figures) and document management techniques
• Strong understanding of the document creation process and of the drug development lifecycle
• Able to synthesize data across multiple data sources and documents to create summary reports
• Expertise to provide subject matter guidance for quality document preparation, document review, accurate comment resolution/incorporation, and document finalization
• Ability to own submission-level sections (e.g., nonclinical section [Module 2.6]), taking responsibility for clarity of purpose, leading others toward the common goal within timeline and budget on complex projects
• Demonstrate an understanding of communication best practices, coaching others on communication implications of decision making
• Develop professional relationships with clients to further business relationships and maintain current industry knowledge
• Ability to identify and institutionalize effective work practices to ensure consistency in performance
• Ability to resolve problems, particularly in sensitive or high-pressure situations
• Broad experience and technical expertise across more than one therapy area, integrating this knowledge to deliver business successes and actively transfer it to strengthen the skill base across the organization

Pay

The estimated hiring range for this role is $132K to $151K 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 considering skills, experience, licensure, certifications, education, specific location, and dynamic market data.

Benefits

Benefits vary by location and may include:

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