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Moderna

Senior Manager, Medical Review Lead

Moderna, Cambridge, Massachusetts, us, 02140

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The Role: We are seeking a scientifically grounded Medical Review Specialist to support the review of promotional and non-promotional materials across Moderna’s growing portfolio of vaccines and therapeutics. In this key contributor role, you will apply your expertise to ensure that Moderna’s external scientific and medical communications are accurate, current, and compliant with applicable medical and regulatory standards.

Working closely with cross-functional teams—including Medical Affairs, Regulatory, Legal, Compliance, and Commercial—you will participate in the content review process to support timely, high-quality medical and promotional materials. You’ll play an important role in upholding the standards of scientific exchange and regulatory compliance that reflect Moderna’s commitment to patient-centered innovation. Here’s What You'll Do: Support the scientific review of promotional and non-promotional materials to verify data accuracy, proper substantiation, and consistency with clinical guidelines and scientific literature.

Contribute content-specific insights to ensure external communications meet regulatory and scientific expectations while aligning with public health priorities.

Participate in review meetings (MRC/PMRT), providing medical input on disease education, product communications, pipeline materials, and training documents.

Collaborate with material owners and reviewers to clarify data interpretation and ensure alignment across therapeutic areas such as infectious disease and oncology.

Assist in the implementation of established review processes and contribute feedback to continuously improve workflows and communication practices.

Support peer training and documentation quality through your knowledge of scientific standards and regulatory frameworks.

Here’s What You’ll Need (Minimum Qualifications): Advanced degree (PharmD, PhD) with scientific specialization in vaccines, infectious diseases, oncology, or related areas.

Minimum of 5 years of relevant experience in the medical review of scientific, training or promotional content in a pharmaceutical or biotech setting.

Working knowledge of global regulatory standards and promotional review requirements (e.g., FDA, EMA, OPDP, EFPIA).

Ability to interpret complex data, summarize clinical evidence, and communicate scientific concepts effectively to diverse stakeholders.

Demonstrated expertise in negotiating with legal, regulatory, and commercial stakeholders, effectively representing the organization's interests while ensuring full compliance with all relevant laws and regulations.

Strong attention to detail and a solutions-oriented mindset.

Comfort working within structured review systems and in a cross-functional, matrixed environment.

Here’s What You’ll Bring to the Table (Preferred Qualifications): Ability to interpret complex clinical data and apply it to diverse scientific and promotional contexts.

Experience and knowledge of FDA, EU, ICH guidelines and regulations.

Demonstrated expertise in requirements for Medical Information Standard Response Letter Review

Highly developed skills in maintaining productive working relationships across multidisciplinary teams, even in high-pressure or conflict-prone scenarios

Proven ability to work independently in a matrixed environment and influence without oversight.

Expert level of proficiency in Veeva Vault is a must

Strong background in leveraging artificial intelligence (AI) technologies in pharmaceutical or healthcare settings.

Flexibility to support work beyond standard office hours, including occasional nights and weekends during congresses, product launches periods and urgent business needs

Excellent written and verbal communication skills; fluency in English required; additional languages a plus

Proficiency in digital technology and familiarity with virtual presentation platforms and Microsoft Office Suite.

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between. Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs A holistic approach to well-being, with access to fitness, mindfulness, and mental health support Lifestyle Spending Accounts to personalize your well-being journey Family planning and adoption benefits Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investment opportunities 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. Our Working Model 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. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities 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 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 an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can 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

. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. -

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