Moderna Therapeutics Inc. Looking for Associate Director, Regulatory Operations – Project Management at Cambridge, Massachusetts Full Time

The Role:

The Associate Director, Regulatory Project Manager will work in close collaboration with Regulatory Strategy and Operational teams, as well as cross-functional teams across the organization (i.e., Clinical, Nonclinical, and Quality) to build and manage timelines to support regulatory filings through licensure and beyond.

Here’s What You’ll Do:

• Define, manage, and track specific deliverables needed for regulatory submissions working with cross-functional teams, including INDs/CTAs, BLAs/MAAs (Modules 1-5), meeting requests, briefing packages, responses to health authority requests, etc.

• Develop submission project timelines that identify key milestones to meet business objectives (e.g. from clinical trial initiation to regulatory submission and approval)

• Track and monitor timelines for key activities (e.g. database lock, document deliverables, authoring responses to health authority questions and meeting regulatory commitments).

• Ensure roles and responsibilities for project team members are clearly documented.

• Lead submission working group cross functional meetings to drive decision making and project execution.

• Ensure creation of agendas, meeting minutes, and tracking/resolution of action items.

• Proactively provide status updates to designated stakeholders via dashboards and milestone reports, and ensure leadership is aware of critical considerations.

• Ensure overall regulatory project timelines are aligned cross-functionally and support the coordination of timely regulatory submissions.

• Identify and recommend solutions for timeline concerns or obstacles, including risks and issues; engaging appropriate leads for mitigation and resolution, ensuring that all issues arrive at a conclusion or recommendation.

• May assist in management of special projects as needed, e.g. oversight of system/process improvement projects.

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

• BS degree in a scientific field with 8 years of experience in a biotechnology or pharmaceutical setting

• Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience

• General knowledge of drug development

• Proven track record of successful project management experience supporting early- and late-stage and submission programs

• Leadership skills, including experience leading multi-disciplinary project teams

• Strong project management skills

• Must be adept at working in a fluid environment and foster a strong collaborative spirit internally and externally

• Strong personal and leadership skills to influence without authority, motivate others and manage conflict

• Strong communicator and team player

• Strong working knowledge of MS Project, Smartsheet and timeline visualization software (i.e. One Pager, ThinkCell)

• Preferred: Project/program management training

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

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit (url removed).

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 (url removed). (EEO/AAP Employer)

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