Senior Manager, Labeling Operations Artwork

The Role:

Joining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases.

As an employee youll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide contributing to global health initiatives.

Modernas commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients lives worldwide.

Moderna is solidifying its presence within our international business services hub in Warsaw Poland a city renowned for its rich scientific and technological heritage. This hub provides critical functions meeting the growing demand of Modernas global business operations. Were inviting professionals from around the world to join our mission and contribute to the future of mRNA medicines.

Moderna is seeking a forward-thinking and detail-oriented Senior Manager to join the Global Regulatory Labeling Operations team at our Warsaw this high-impact role youll be responsible for ensuring swift compliant and high-quality delivery of product labeling across a growing and innovative mRNA portfolio. Your regulatory expertise will support the creation revision and submission of global product labelingparticularly for new market entries across the Middle East and Asia Pacific. This role offers the opportunity to contribute to Modernas labeling strategies and play a pivotal part in scaling our regulatory operations globally.

Heres What Youll Be Doing:

Your key responsibilities will be:

• Supporting the creation and revision of prescribing information particularly for new market expansion across the Middle East and Asia Pacific regions.

• Managing regulatory submissions of labeling content and supporting documentation to global health agencies.

• Acting as a labeling expert in Global Regulatory Affairs Sub Teams (GRSTs) for submission activities.

• Interfacing cross-functionally with Regulatory Strategy Leads Strategists and Project Teams to ensure labeling consistency and compliance.

Your responsibilities will also include:

• Applying in-depth knowledge of regulatory labeling regulations and industry best practices to advise stakeholders.

• Contributing to and managing change controls and the labeling control process for tracking and implementing updates to existing labeling.

• Ensuring compliance with Company Core Data Sheet (CCDS) requirements across regions.

• Overseeing end-to-end labeling processes and their documentation within the electronic document management system.

• Contributing to regulatory artwork development review and approval workflows.

• Monitoring industry trends and emerging standards to influence internal practices and engage with external stakeholders.

The key Moderna Mindsets youll need to succeed in the role:

• We digitize everywhere possible using the power of code to maximize our impact on patients.
  In this role success depends on understanding and using digital systems for labeling operations and regulatory document management. Youll work in a highly automated tech-forward environment that thrives on streamlining and scaling regulatory workflows through digital tools.

• We obsess over learning. We dont have to be the smartest; we have to learn the fastest.
  With an evolving global footprint and rapidly changing regulations youll need to stay current on global health authority expectations and anticipate regulatory shifts in fast-growing regions. Your ability to quickly absorb and apply new regulatory knowledge will directly impact Modernas ability to scale.

Heres What Youll Bring to the Table:

• Bachelors degree required; Advanced degree preferred

Experience:

• At least 5-8 years of relevant experience in the pharmaceutical industry with preferably 5 years in Regulatory Affairs and specific experience in labeling

• Extended knowledge of science and data of assigned products and how that translates into labeling language.

• Hands-on assistance with the delivery of labeling for at least one major application (NDA/BLA/MAA/JNDA etc.)

Specific skills:

• Experience facilitating meetings and driving consensus and results.

• Excellent leadership communication (verbal and writing) and collaboration skills.

• Proven ability in medical/technical writing.

• Labeling experience (CCDS US EU) in infectious diseases or vaccines or other relevant industry experience related to developing regulatory documentation is desirable.

• Integrity: overriding commitment to integrity and high standards for self and others.

• Achievement/Result Orientation: a commitment to working to meet/exceed objectives and deliverables.

• Strategic orientation: ability to link Modernas vision and strategic objectives with daily work.

• Communication: ability to effectively convey information to a variety of audiences. Specifically interacts effectively as member of the GRSTs and collaborates effectively with business partners including affiliates and third parties.

• 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 and maintains collaborative relationships with people and demonstrates desire to work well with others.

Problem solving:

• Analytical thinking: understand a situation or complex information by breaking it into small parts to better understand and solve problems.

At Moderna we believe that when you feel your best you can do your best work. Thats why our global benefits and well-being resources are designed to support youat work at home and everywhere in between.

• Quality healthcare and insurance benefits
• Lifestyle Spending Accounts to create your own pathway to well-being
• Free premium access to fitness nutrition and mindfulness classes
• Family planning and adoption benefits
• Generous paid time off including vacation bank holidays volunteer days sabbatical global recharge days and a discretionary year-end shutdown
• Savingsandinvestments
• Location-specific perks and extras!

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

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 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 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 committed to equal opportunity in employment and non-discrimination 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. 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 accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment 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 and Adjustments team at .

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