Associate Director, PV Operations - Compliance, SOPs & Training

The Role:

Moderna is seeking an Associate Director responsible for managing compliance, procedures and training related to all pharmacovigilance activities. This individual will report to the Sr. Director, PV operations- Compliance and Policy. This role will be responsible for supporting the PV functions in development of SOPs and relevant training materials as it related to all Moderna PV related activities. This role will closely work with the functional team to manage and monitor compliance to the relevant activities including deviation and CAPA management for PV related activities. This individual will work closely with the relevant functions in PV to help 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 to build and establish an industry-leading PV team as we launch our COVID-19 vaccine (mRNA 1273) globally to hundreds of millions of patients 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 and a key senior PV leader overseeing all of our Clinical Safety and PV efforts in support of ensuring patient safety for patients who receive Moderna’s experimental and authorized products. In addition, this role will have the opportunity to make critical contributions 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:

• Manage compliance, deviations, CAPA, PV procedures and training for the PV department.

• Collaborate with PV and other departments (GRA, Clinical, Medical Affairs, Commercial ) to ensure a robust pharmacovigilance system.

• Work with PV function to define compliance metrics and generate a monthly compliance report

• Responsible for and manage deviations, investigating non-compliance and creation of CAPA in collaboration with the business owner

• Work on Inspection and audit observation to develop robust CAPAs to ensure efficient solutions are implemented

• Responsible for reviewing deviations and performing trend analysis

• Initiate and lead process improvements including creation, updates of relevant PV procedures

• Managing department wide training for both the PV functions and relevant PV vendors to ensure robust training plans are in place and monitor training compliance on an ongoing basis

• Working closely with commercial functions to review and approve commercial programs (e.g. MRPs) to ensure they are in compliance with PV requirements

• Work cross functionally with other departments to ensure that procedures and deviations are in place for relevant activities

• Engaging externally to ensure ongoing benchmarking and the leveraging of best practices.

• Serve as SME for PV compliance

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

• Bachelor's degree (preferably in a science or health related field) and a minimum of 7 years of experience in Pharmacovigilance, with at least 3 years of experience in Pharmacovigilance Operations

• Strong experience in quality and deviation management, trend analysis and CAPA management

• Experience in writing SOPs, Work Instructions …

• Training management /development experience a plus

• Knowledge of PV operations and regulations

• Strong communicator 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 for 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.

• Ability to manage multiple projects in a fast-paced environment.

Here’s What We’ll Bring to the Table:

• On-site subsidized cafeteria or catered lunches
• Company-provided iPhone
• Free parking, monthly subway pass or a subsidized commuter rail pass
• Free annual corporate membership to Bluebikes
• Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
• Flexible Spending Accounts for medical expenses and dependent care expenses
• 16 weeks of 100% paid parental leave for all new parents
• 16 weeks 100% paid family caregiver leave
• 20 weeks 100% paid medical leave
• Eligible for “Moderna Month” (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
• Adoption assistance and discounts to local childcare centers, as well as access to care.com
• 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
• A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
• Voluntary legal assistance plan
• 15 days’ vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)

About Moderna:

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com .

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.