Principal Medical Writer

1 week ago

Princeton, United States Meet Full time

Job Summary: The Principal Medical Writer (MW) provides MW leadership and subject matter expertise to cross-functional project teams and drives the efficient development of study-level and program-level clinical regulatory documents. She or he is a strategic thinker and decision maker who effectively collaborates with internal and external stakeholders to coordinate document content, quickly resolve conflicts, and meet established timelines.


Duties And Responsibilities


  • Research, write, and edit complex clinical and cross-functional documents to advance and meet the regulatory requirements of development programs.
  • Study-level documents include Phase 1-4 protocols and clinical study reports.
  • Program-level documents include investigator brochures and other clinical IND modules, clinical summary and overview NDA modules, and responses to information requests for submission to worldwide health authorities in eCTD format.
  • Contribute to the overall regulatory strategy for clinical development programs and align study-level and program-level documents to support key messages and labeling objectives.
  • Ensure that MW deliverables are developed, reviewed, and quality checked according to MW procedures, and that document structure, content, and format/style complies with document templates and regulatory/industry standards.
  • Review draft eCRFs as part of protocol development to ensure all appropriate data are captured.
  • Review SAPs and mock tables/figures/listings to ensure they meet expectations for reporting.
  • Work with key stakeholders to maintain compliance with ClinicalTrials.gov requirements (eg, timely protocol registration and results reporting).
  • Lead the development, management, and continuous improvement of MW procedures and standards. Ensure proper and timely training to optimize the introduction and implementation of new procedures and technologies.
  • Advise authors from other functions on MW best practices and the use of MW technologies to support the efficient development of regulatory documents across disciplines.
  • Task manage/mentor the activities of less experienced personnel.

List Of Qualifications


  • Bachelor of Arts or Science degree in English or life science.
  • Minimum of 8 years of MW experience in the pharmaceutical industry (small pharma and/or CRO experience preferred).
  • Successful track record of independently leading complex clinical and cross-functional regulatory writing projects, including having been the lead writer for a marketing application.
  • Demonstrated ability to manage competing priorities and perform in high-pressure situations.
  • Excellent understanding of the drug development process and health authority regulations/ industry guidelines pertaining to global dossiers.
  • Demonstrated ability to critically analyze, interpret, and summarize complex information from a range of scientific disciplines and clinical therapeutic areas.
  • Proficient at leading without formal authority (influence, negotiation, resourcefulness).
  • Expert user of Microsoft Word, electronic Common Technical Document templates/style ribbons, and document management systems.
  • Mastery of the English language (written and spoken).
  • Excellent organization, time management, and attention to detail.
  • Customer-oriented and flexible.
  • Multicultural sensitivity; builds positive and productive relationships; pursues diverse input on proposals and decisions.

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