- Lead the review and editing of CMC source documents for global regulatory submissions, following the Common Technical Documentation (CTD) format.
- Establish and maintain Moderna's documentation standards to ensure consistent messaging and quality across the product portfolio.
- Mentor technical teams on effective technical writing principles, highlighting the importance of documentation excellence for project success and career advancement.
- Collaborate with cross-functional teams to align documentation practices with global regulatory strategies and submissions.
- Educate subject matter experts on anticipating health authority inquiries to minimize post-approval commitments through clear, comprehensive, and persuasive documentation.
- Advanced degree in a scientific or related field with substantial experience in regulatory affairs, specifically CMC documentation for biotech or pharmaceutical products.
- Minimum of 10 years of experience in the biotechnology or pharmaceutical industry, demonstrating leadership in documentation for global regulatory filings.
- Thorough knowledge of global regulatory requirements and the ability to translate complex scientific information into regulatory documents.
- Exceptional writing, coaching, and communication skills to enhance the quality of technical documentation.
- Experience in guiding teams through regulatory processes to meet health authority standards.
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Director, Technical Documentation - Norwood, United States - Moderna
Description
Position: Director, Technical Documentation at Moderna
Moderna's Technical Development organization is seeking a skilled Director, Technical Documentation with extensive experience in crafting and updating Chemistry, Manufacturing, and Controls (CMC) source documents for global regulatory submissions of biotech products.
The Director will play a key role in ensuring the creation of high-quality documentation throughout all stages of product development, guaranteeing clarity and compliance with global regulatory standards. This will streamline the review and approval process by health authorities.
Minimum Qualifications:
Preferred Qualifications:
If you are passionate about making a difference and want to be part of a dynamic company committed to transforming medicine, Moderna could be the perfect place for you. Join us and be part of a culture that values innovation and teamwork.
Moderna offers a comprehensive benefits package for you and your family, including competitive medical, dental, and vision coverage, lifestyle spending accounts, family care benefits, and more.
Get ready to enjoy generous paid time off, 401k match, financial planning tools, and a range of other perks that support your well-being both at work and in your personal life.
At Moderna, we are dedicated to fostering a diverse and inclusive workplace where every employee can thrive. We believe that by embracing a range of experiences and backgrounds, we create an environment where all employees can excel and contribute their best.
If you are ready to embark on a career with Moderna and meet the qualifications for this role, submit your application today. Be part of a company that is shaping the future of medicine and making a positive impact on the world.
