• Job Description

  Req#: R14499

  The Role:

  Reporting to the Executive Director of Medical Writing and Clinical Trial Transparency and Disclosure, the Senior Director of Submissions - Medical Writing will be responsible for planning, managing, and overseeing the development of high-quality regulatory documents for complex Biologics License Applications (BLAs) or other marketing applications. This role requires a strong ability to lead a team of medical writers, collaborate with cross‑functional teams, and stay abreast of current industry trends and regulatory requirements.

  The Senior Director of Submissions - Medical Writing holds a crucial role within Moderna’s organization. This position leads the development of high-quality regulatory documents in preparation for marketing applications, a process that is fundamental to Moderna’s success. With a deep understanding of regulatory guidelines and strong background in medical writing, the Senior Director ensures that all documents meet industry standards and regulatory requirements. They provide invaluable leadership, guiding and mentoring a team of medical writers, and collaborate with various cross-functional teams. Their strategic planning and problem-solving abilities contribute significantly to our mission of bringing innovative therapies to patients. This role, therefore, is not only pivotal in maintaining regulatory compliance but also in shaping the company's trajectory in the pharmaceutical and biotechnology industry.

  Here’s What You’ll Do:

  • Functional Knowledge: Recognized Expertise in BLA and MAA submissions and proven ability to provide technical guidance and direction for submissions.

  • Strategic Planning: Develop and implement strategic plans for the submission of BLAs and other marketing applications.

  • Key Messaging and Storyboarding: Lead the development and implementation of key messaging and storyboarding for complex BLA submissions. Ensure that the narrative across all documents is consistent and aligned with the overall strategic communication plan. This includes mapping key messages, developing strategic plans, and using storyboarding and message mapping to ensure program documents are coordinated, consistent, and aligned.

  • Team Leadership: Lead a team of medical writers, providing guidance, mentorship, and training to ensure the delivery of high-quality work. Lead dynamically through senior managers or professionals; translate and execute functional business strategy across multiple related disciplines and contribute to strategic planning for submission documents.

  • Cross-functional Collaboration: Collaborate with cross-functional teams, including clinical, regulatory, biostatistics, pharmacovigilance, and project management, to ensure alignment and compliance with project requirements.

  • Problem Solving: Resolve unique and highly complex problems with wide reaching implications on the business.

  • Quality Assurance: Review and edit documents for accuracy, consistency, and quality. Ensure all documents meet industry standards and regulatory requirements. Guided by functional plans, impact quality and timeliness of submission plans and documents.

  • Industry Trends and Best Practices: Stay abreast of current industry trends, regulatory requirements, and best practices in medical writing. Implement these insights as necessary to maintain the department's competitiveness. Apply basic market knowledge to drive integrated results in developing submission documents across multiple related teams.

  • Regulatory Compliance: Ensure all submission documents comply with ICH guidelines, FDA regulations, EMA regulations, and GCP.

  • Risk Management: Identify potential risks in the submission process and develop contingency plans to address them.

  • Impact: Advocate for resources to impact long-term operational, project, or program outcomes for the company.

  Here’s What You’ll Bring to the Table:

  • Education: Advanced degree in Life Sciences, Pharmacy, or Medicine (PhD, MD, PharmD preferred).

  • Years of Experience: Minimum of 10 years of experience in submissions writing within the pharmaceutical or biotechnology industry.

  • Strong knowledge of ICH guidelines, FDA regulations, EMA regulations, and GCP.

  • Industry Experience: Proven track record in successful BLA or marketing submissions. Demonstrated experience in regulatory document preparation and submission, particularly BLAs. Experience working with CROs, vendors, and relationship management preferred.

  • Leadership Skills: Ability to lead cross-functional teams or projects characterized by high complexity and integration requirements with notable visibility. Comprehensive understanding of concepts and principles for overseeing the managing medical writing and regulatory writing across multiple submissions.

  • Business Expertise: Expert ability to interpret internal/external business challenges and develop best practices to improve process and services.

  • Interpersonal skills: Exceptional ability to communicate highly complex ideas, anticipate potential objections, interact with senior leaders and apply advance negotiation skills.

  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 options
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
  • Family care benefits, including subsidized back-up care options and on-demand tutoring
  • Free premium access to fitness, nutrition, and mindfulness classes
  • Exclusive preferred pricing on Peloton fitness equipment
  • Adoption and family-planning benefits
  • Dedicated care coordination support for our LGBTQ+ community
  • Generous 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 thereafter
  • Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
  • 401k match and Financial Planning tools
  • Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
  • Complimentary concierge service including home services research, travel booking, and entertainment requests
  • Free parking or subsidized commuter passes
  • Location-specific perks and extras!

  About Moderna

  Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure 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 people are 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.
  
  If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers 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. We’re 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 make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

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• About the company

  091 Moderna, Inc., is an American pharmaceutical and biotechnology company based in Cambridge, Massachusetts that focuses on RNA therapeutics, primarily mRNA vaccines.

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