Principal Medical Writer-nonclinical focus

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 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.

• Work closely with client and internal and partner organization teams to lead development of strategies for organizing and preparing regulatory documents
• Lead a project team, and actively participate in development and writing of high‑quality documents (study‑level and submission‑level documents, pharmacovigilance documents)
• Author documents per client specifications, templates, style guides, and other guidance documents
• Author documents per regulatory authority guidelines and requirements
• Act as client advisor, working collaboratively and developing a strong relationship of trust built upon consistent and reliable communication; communicate ideas and strategies to produce a successful end result
• Practice blameless problem solving, taking broad perspectives in resolving issues to prevent negative impact to work
• Manage budget for a low‑complexity project, including all contributors (writers, editors)
• Usher documents through the review process, conduct comment resolution meetings (CRMs) and lead a project team to consensus
• Maintain collaborative, proactive, and effective communication with both clients and internal teams
• Lead project‑related meetings and teleconferences
• Provide coaching to junior staff for study‑level documents as well as submission‑level documents and ensure all staff comply with company standard operating procedures (SOPs) and training requirements

• 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

• The estimated hiring range for this role is $132 K to $151 K plus applicable bonus. This hiring range is specific to the US and will vary for other regions based on local market data. Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to: skills and experience, licensure and certifications, education, specific location, and dynamic market data.
• Benefits vary by location and may include:
  Remote working, Flexible time off, Paid holidays, Medical insurance, Tuition reimbursement, Retirement plans

• 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 or Toxicology Reports
• ADME Reports
• Understand regulatory authority guidelines and requirements to be able 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 (does not require functioning as a document lead)

• 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 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, review, accurate comment resolution/incorporation, and finalization
• Ability to own submission‑level sections (e.g., nonclinical section [Module 2.6]), taking responsibility for clarity of purpose, leading others…