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Director, Global Regulatory Labeling, Respiratory Franchise
2 months ago
The Role:
Moderna Therapeutics is seeking a Director of Regulatory Labeling to support new programs to be based in the Cambridge headquarters. This is a newly created role intended for a forward looking, creative regulatory professional able to anticipate and address the challenges involved in swiftly delivering labeling for new respiratory products (COVID, COVID/flu combo and RSV, for example), especially in the United States and other major markets.
This role will be a strategic leader within Global Regulatory Science, responsible for developing and executing regulatory labeling, especially generation of new US prescribing information and changes to existing labeling, and submission of labeling information to Health Agencies. This role will also be responsible for leading and supervising our consultants and service providers.
Here's What Youll Do:
Develop and maintain current knowledge of labeling regulations and industry standards for labeling and communicate requirements to stakeholders as needed.
Direct the labeling control process for tracking, implementation, and regulatory submission of new labeling for US/major markets for Modernas respiratory franchise products.
Develops labeling content, format and accountability for regulatory submissions (BLAs) and related supplements and amendments. Ensure that new labeling text meets regulatory labeling requirements.
Develops content for artwork related to BLAs and related supplements and amendments. Works with cross-functional team and provides input on new trade names, established names, graphics and logos.
Interface with Project Teams to ensure consistency of labeling processes and local compliance with CCDS.
Effectively communicate the regulatory labeling strategy, risks, mitigations and overall plans to the Global Regulatory Science Management Team, Project Development Team and senior management, as relevant.
Partner with the Global Regulatory Lead to develop Target Label Profiles to support all phases of clinical development.
Provide input to the end-to-end labeling process.
Liaise within pharmaceutical/biotech industry to maintain knowledge of evolving/emerging industry standards and trends; and influences the industry environment regarding labeling.
This position may need to help with coverage on other products during peak periods or during absences of other team members.
May be responsible for line management and development of direct reports in the future.
Heres What Youll Bring to the Table:
BA/BS degree in a scientific discipline required, Masters or PhD preferred.
10+ years of experience in the pharmaceutical industry
7+ years of experience in Regulatory labeling
Strong knowledge of artwork development, review and approval required.
Strong knowledge of current global regulations, including specifically: e.g. vaccine development regulations and registrations pathways.
Strong experience with CTD format and content regulatory filings
Exceptional written and oral communication
Experience dealing with broad range of stakeholders at all levels internal and external to the company
Delivery of labeling for at least one major application (NDA/BLA/MAA, etc.)
Experience facilitating meetings and driving consensus and results.
Excellent leadership, communication (verbal and written) and collaboration skills.
Proven ability in medical/technical writing.
Labeling experience (CCDS, US, EU, other major markets) in infectious diseases or vaccines or other relevant industry experience related to developing regulatory documentation is desirable.
Innate sense of urgency in regards to FDA/EMA/MHRA/other HA communications and response timelines to provide coverage for product approvals and labeling negotiations.
Integrity: overriding commitment to integrity and high standards in self and others.
Achievement or result orientation: a concern for working well or for surpassing a standard of excellence.
Strategic orientation: ability to link visions and daily work
Communication: ability and intend to effectively explain, describe or convey information to a variety of audiences. Specifically, interacts effectively as member of the regulatory sub-team, communicates effectively on these strategies to the Global Labeling Committee and collaborates with business partners, including affiliates and third parties.
Develops others: involved in a genuine intent to foster development of others; mentoring
Flexibility/adaptability: ability to adapt to, and work effectively within a variety of situations and with various individuals or groups.
Relationship building, teamwork and cooperation: builds or maintains friendly relationship with people and demonstrates desire to work.
Problem solving and analytical thinking: understand a situation by breaking it apart into small pieces or tracing the implications of a situation in a step-by-step way. Systematically organizing the parts of a problem.
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 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. 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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)#LI-LG1
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