Director, PV Operations Compliance, Alliance, and Process Excellence
ModernaTX, Inc.

The Role:

Moderna is seeking a Director, PV Operations Compliance, Alliance, and Process Excellence responsible for ensuring the highest level of complianceas part of Moderna's Pharmacovigilance Quality Management System by providing oversight of commercial programs, establishing a framework for affiliate PV standards, and managing business continuity. This individual will report to the Sr. Director, PV Operations- Compliance, Alliance, and Process Excellence. This role will be responsible for defining, driving, and implementing the PV strategies for process standards across the PV system to ensure compliance, standardization to support evolving market presence for Moderna leveraging innovation and technology. This individual will work closely with the relevant functions across Moderna to ensure compliance of the PV system at Moderna.

Moderna seeks candidates aligned with its culture centered on bold, collaborative, curious, and relentless values, which enable innovation in mRNA-based vaccines and therapeutics to benefit patients.

This is an exciting time to join Moderna as we expand our product reach globally to hundreds of millions of people and experience acceleration in our pipeline and late phase development, thereby poising Moderna for substantial growth in the upcoming years. This role will be a key contributor to Moderna's future success in making a transformative impact to patients through our vaccines and therapeutics using our mRNA platform.

Here's What You'll Do:

• Oversee the development and implementation of frameworks for the management of commercial programs (i.e., PSPs, MRPs, Digital Initiatives), business continuity, and global country operations to ensure pharmacovigilance compliance and inspection readiness.
  
• Collaborate with PV functional areas and other departments (Pharmacovigilance Quality, Global Regulatory Sciences, Clinical Development, Medical Affairs, Commercial) to ensure a robust pharmacovigilance system at Moderna.
  
• Provide oversight for the development of relevant KPIs, processes, and systems.
  
• Oversee and manage the review and approval of commercial programs, providing PV expertise and ensuring fit-for-purpose solutions to secure compliance.
  
• Oversee the establishment of the BCP process, and function as the BCP Lead
  
• Ensure testing of the Global BCP in collaboration with PV SMEs/Functional leads
  
• Provide strategic oversight in the development of frameworks for relevant PV system processes for implementation across geographies to ensure consistency.
  
• Identify gaps and areas of improvement within the PV system and lead strategic initiatives to address them.
  
• Lead process improvements, including the creation and updating of relevant PV procedures to drive overall CSPV strategies.
  
• Provide strategic oversight in defining and implementing strategies and action plans for risk management across the PV system globally.
  
• Collaborate with Head of Regions and QPPV to ensure the establishment of a robust local PV system.
  
• Build strong, open, and collaborative working relationships with both internal and external stakeholders and matrixed project teams.
  
• Maintain up-to-date knowledge of global regulatory requirements.
  
• Lead internal and external interactions to ensure quality, compliance, and standardization.
  
• Provide input into business strategy as it relates to compliance and policy.
  
• Engage externally to ensure ongoing benchmarking and the leveraging of best practices.
  
• Serve as SME for PV to provide guidance for quality and compliance issues, procedural/policy impact, and inspection readiness.
  
• Serve as a deputy for Head of Compliance, Alliance, and Process Excellence as needed.
  
• Collaborate cross-functionally to foster a culture of compliance and quality first time right.
  

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

• Bachelor's degree (preferably in a science or health-related field) and a master's preferred.
  
• A minimum of 7-10 years of experience in Pharmacovigilance, with demonstrated strategic leadership in Pharmacovigilance Operations and PV affiliate Operations.
  
• Expertise in PV regulations and implementation of PV processes.
  
• Significant experience in the management of commercial programs and oversight for PV controls.
  
• Experience with Health Authority Inspection interviews/process and management.
  
• Strong communication skills and ability to partner closely and effectively cross-functionally and cross-regionally.
  
• Experience working with all levels of management and consulting with key business stakeholders, including an ability to influence outcomes.
  
• Excellent interpersonal skills, ability to develop relationships with key stakeholders, conflict management and negotiation skills, and ability to identify issues and raise them to key stakeholders to develop relevant and realistic plans, programs, and recommendations.
  
• Excellent analytical skills and an ability to communicate complex issues simply and propose solutions.
  
• Ability to manage multiple, complex projects in a fast-paced environment.
  

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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