Associate Director, PV Operations Compliance, Alliance, and Process Excellence

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 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 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.

Here’s What You’ll 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

Here’s What You’ll 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 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 premiu