Medical Writer Lead

19 hours ago


Princeton, New Jersey, United States UroGen Full time
Job Description

We are seeking a Medical Writer Lead to join our team. In this role, you will provide strategic leadership and subject matter expertise in the development of clinical regulatory documents.

You will lead the development of study-level and program-level clinical regulatory documents, ensuring compliance with regulatory requirements and industry guidelines.

Duties and Responsibilities
  • Develop complex clinical regulatory documents, including protocols, clinical study reports, and investigator brochures.
  • Collaborate with internal stakeholders to ensure document content meets regulatory requirements and aligns with business objectives.
  • Maintain up-to-date knowledge of regulatory requirements and industry guidelines to ensure compliance.
  • Provide guidance and training to less experienced personnel on regulatory writing best practices.
Requirements
  • Bachelor's degree in English or life science.
  • Minimum 8 years of experience in medical writing and regulatory affairs, preferably in the pharmaceutical industry.
  • Proven track record of independently leading complex projects and managing competing priorities.
  • Excellent understanding of the drug development process and health authority regulations.
  • Strong analytical and problem-solving skills, with excellent written and verbal communication skills.
Compensation Package

The estimated annual salary for this role is $165,000.



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