Senior Manager Medical Review Lead

The Role:

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

Working closely with crossfunctional teamsincluding Medical Affairs Regulatory Legal Compliance and Commercialyou will participate in the content review process to support timely highquality medical and promotional materials. Youll play an important role in upholding the standards of scientific exchange and regulatory compliance that reflect Modernas commitment to patientcentered innovation.

Heres What Youll Do:

• Support the scientific review of promotional and nonpromotional materials to verify data accuracy proper substantiation and consistency with clinical guidelines and scientific literature.

• Contribute contentspecific 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.

Heres What Youll 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 organizations interests while ensuring full compliance with all relevant laws and regulations.

• Strong attention to detail and a solutionsoriented mindset.

• Comfort working within structured review systems and in a crossfunctional matrixed environment.

Heres What Youll 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 highpressure or conflictprone 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. Thats why our US benefits and global wellbeing resources are designed to support youat work at home and everywhere in between.

• Bestinclass healthcare coverage plus a suite of voluntary benefit programs to support your unique needs
• A holistic approach to wellbeing with access to fitness mindfulness and mental health support
• Lifestyle Spending Accounts to personalize your wellbeing journey
• Family planning and adoption benefits
• Generous paid time off including vacation volunteer days sabbatical global recharge days and a discretionary yearend shutdown
• Savings and investment opportunities
• Locationspecific 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 worldclass 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 inperson culture is critical to our success. Moderna champions the significant benefits of inoffice collaboration by embracing a 70/30 work model. This 70 inoffice 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 to learn more about our current opportunities.

Moderna is a smokefree alcoholfree and drugfree 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 committed to equal employment opportunity and nondiscrimination for all employees and qualified applicants without regard to a persons 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 EVerify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.

Were 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 . (EEO Employer)