Principal Medical Writer

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.