Senior Specialist, Regulatory Intelligence
ModernaTX, Inc.

Job Info

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The Role

In this role, you will primarily focus on supporting Regulatory Intelligence activities, including 1) managing and tracking ongoing activities for assessing impact to Moderna from updates to global regulations and 2) monitoring, managing, and tracking regulatory news and updates necessary to enable proper dissemination with key business stakeholders in Moderna. The appointee will support R&D Quality in creating a quality culture through promoting knowledge sharing and advancing Regulatory Intelligence activities.

Here's What You'll Do

• Contributes to managing and tracking ongoing gap analyses and impact assessments against updated regulations, including conducting appropriate follow-up with key business stakeholders
  
• Contributes to managing metadata in our business-facing regulatory intelligence platform, including providing updates to taxonomy and performing appropriate tagging, such that intelligence is accessible and received by the appropriate business functions
  
• Assists with populating intelligence trackers housed on MS SharePoint and other MS Office applications
  
• Liaises with appropriate GxP Leads and experts for soliciting input on key pieces of intelligence to be assessed for impact to Moderna
  
• Maintains and manages key regulatory intelligence resources, including SME lists, commenting timelines, and others
  
• Assists with monitoring regulatory updates and analyzing their impact
  
• Collaborates and maintains relationships with key business partners
  
• Contribute to key projects as required
  
• Assists with administrative duties as needed, including taking minutes and assigning action items during the flow of various regulatory intelligence workstreams requiring alignment
  
• Support of GCP, GVP, GLP, GCLP regulatory authority inspection activities
  
• Support of RDQ projects and initiatives, as assigned
  
• Contribute to the continuing development of a quality culture at Moderna
  

Here's What You'll Need (Minimum Qualifications)

• BS/BA, MS or PhD and a minimum of 2 years of life science experience, with a focus in Regulatory, Drug Safety, or Clinical operations in a Biotech, Pharma or Clinical Research Organization.
  
• Experience leading cross-functional meetings within matrixed environments
  
• This role is based in our new LEED-certified HQ in Cambridge, MA and is expected to be in office 70% of the time with flexibility to work from home up to 30%.
  

Here's What You'll Bring to the Table (Preferred Qualifications)

• Knowledge in the drug development and clinical development life cycle
  
• Independent and motivated, capable of researching solutions and extrapolating critical information from technical and regulatory documents
  
• Data-focused, an organized approach to managing projects, and attentive to detail in support of the Regulatory Intelligence program execution
  
• Experience and proficiencies in MS SharePoint, MS Excel, MS Word, and MS PowerPoint
  
• Ability to work both independently and in a team environment.
  
• Ability to manage multiple projects in a fast-paced environment.
  
• Strong communication and presentation skills, both verbal and written.
  
• 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 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.

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. 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 contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

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