Principal Medical Writer

UroGen Pharma • Princeton, NJ

363d

About The Position

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.

Requirements

• 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.

Responsibilities

• Research, write, and edit complex clinical and cross-functional documents to advance and meet the regulatory requirements of development programs.
• Develop study-level documents including Phase 1-4 protocols and clinical study reports.
• Create program-level documents such as 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees