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Associate Director, PV Operations Compliance, Alliance, and Process Excellence
2 months ago
The Role:
Moderna is seeking a Associate Director, PV Operations Compliance, Alliance, and Process Excellence responsible for ensuring the highest level of complianceas part of Modernas 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 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.
Heres What Youll Do:
Implement the framework for the management of commercial programs (i.e. PSPs, MRPs, Digital Initiatives), business continuity and global framework for country operations to secure pharmacovigialnce 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.
Implement framework for commercial programs management and establish oversight mechanism via development of relevant KPIs, process and systems.
Manage day to day activities related to commercial programs and provide expertise and fit for purpose solutions for these programs
Drive the BCP process and manage testing and function as the BCP Lead
Identify gaps and areas of improvements within the PV system
Initiate and lead process improvements including creation, updates of relevant PV procedures
Define and implement strategies and action plans for identifying and managing risks across the PV system across the geographies on an ongoing basis
Lead and implement regulatory and PV systems and other infrastructure evolvement, as assigned,
Support establishment of a robust local PV system in collaboration with Head of Regions
Build strong, open and collaborative working relationships with both internal and external stakeholders and matrixed project teams
Maintain up-to-date knowledge on 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
Engaging externally to ensure ongoing benchmarking and the leveraging of best practices.
Collaborate cross-functionally to foster a culture of compliance and quality first time right
Heres What Youll Bring to the Table:
Bachelors degree (preferably in a science or health-related field) and a master preferred
Expertise in PV regulations and implementation of PV processes
A minimum of 7 years of experience related to Pharmacovigilance with preferred Pharmacovigilance affiliate operations knoweldge
Preferred experience with management of commercial programs and oversight for PV controls
Experience with Health Authority Inspection interviews/process and management
Strong communication 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 greater outcomes.
Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs, and recommendations.
Excellent analytical skills and an ability to communicate complex issues in a simple way 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 optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous 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 thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras
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 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. Were 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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