Sr. Director, Technical Documentation
2 weeks ago
The Role
Modernas Technical Development organization is looking for a Sr. Director, Technical Documentation with significant experience in creating and revising Chemistry, Manufacturing, and Controls (CMC) source documents for global regulatory submissions of biotech products. The Sr. Director will drive the development of consistent, high-quality documentation across all stages of product development, ensuring clarity and compliance with global regulatory expectations, thereby facilitating a smoother review and approval process by health authorities.
Heres What Youll Do Lead the review and editing process for CMC source documents intended for global regulatory submissions, adhering to the Common Technical Documentation (CDT) format. Establish and uphold Modernas documentation standards, ensuring consistent messaging and quality across the entire product portfolio, from early development to commercial stages. Mentor and guide technical teams in the principles of effective technical writing, emphasizing documentation excellence as a critical component of project success and individual career growth. Collaborate with cross-functional teams within CMC and Regulatory Affairs to harmonize documentation practices with global regulatory strategies and submissions. Educate and support subject matter experts in the proactive anticipation of health authority inquiries, aiming to minimize post-approval commitments by crafting clear, comprehensive, and persuasive documentation. Additional duties as may be assigned from time to time. Heres What Youll Need: Bachelors degree required with substantial experience in regulatory affairs, specifically CMC documentation for biotech or pharmaceutical products. Advanced degree in a scientific or related discipline strongly preferred. Minimum 10 years experience in the biotechnology or pharmaceutical industry, with a proven track record of leading documentation efforts for global regulatory filings. Heres What Youll Bring to the Table (Preferred Qualifications) Strong knowledge of global regulatory requirements with the ability to translate complex scientific information into regulatory documents. Exceptional writing, coaching, and communication skills, with a focus on educating scientists and engineers to enhance the quality of technical documentation. Experience in guiding teams through the regulatory landscape, with an emphasis on strategy and execution of documentation that meets health authority standards. A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:
Vacation, sick time and holidays
Volunteer time to participate within your community
Discretionary year-end shutdown
Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at (EEO/AAP Employer)#LI-KP1
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