Sr. Manager, PV Operations, Project Management

The Role:

Reporting to the Director of Project Management PV Operations, the Senior Manager PV Project Management is a important contributor assisting the PV PM team in supporting operational, strategic and cross-functional initiatives across Clinical Safety and Pharmacovigilance (CSPV), Clinical Development and the larger Moderna organization.

An ability to approach projects with big picture and agile thinking is necessary to liaise across CS&PV, applicable cross-functional teams, and Modernas evolving vendors, partners, and distributors to ensure on time delivery of PV initiatives and key deliverables. The Senior Manager, PV Operations Project Management will support and help develop optimization strategies that deliver increased productivity, efficiency, and effectiveness across the CSPV team.

This is an exciting time to join Moderna as we 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 will have the opportunity to make critical contributions to Modernas future success in making a transformative impact to patients through our vaccines and therapeutics using our mRNA platform.

Heres What Youll Do:

• Provide end to end project management support to Clinical Safety & Pharmacovigilance team (CSPV) team, based on prioritization in the current portfolio of projects.

• Partner with the business process owner in the project to manage timelines, risks and stakeholders to the project assigned.

• Support drafting content for Communications for internal and/or external distribution on behalf of the CSPV organization and/or its functional experts.

• Support Modernas Digital teams to support the implementation and change management for new systems utilized by CSPV users and/or impacting CSPV processes.

• Support the continuous improvement of the overall Moderna PV framework by helping to navigate uncharted territory where no process or precedent exists, while maintaining compliance with internal procedures and industry regulations (GxP).

• Provide coordination support for aggregate safety reports optimization by closely collaborating with the applicable Aggregate Safety Reporting Lead, Safety Physician, PV Scientist and relevant cross-functional stakeholders to ensure on time delivery of PBRERs/PSURs, PADERs, DSURs, and IND annual reports for Modernas marketed or in development products.

• Responsible for planning and managing all administrative and operational meeting activities for the CSPV All-staff team, including managing the agenda, facilitating meeting, and occasionally handling important follow-up items.

• Partner with the Financial and Contract Management team to manage and review selected vendor contracts, SOW, Change Order and invoices for appropriate documentation and approval prior to payment

Heres What Youll Bring to the Table:

• Bachelors degree (preferably in a health related field) and a minimum of 5 years of experience in Pharmacovigilance in Biotech, Pharma or a Clinical Research Organization.

• Knowledge of ICH guidelines relevant to PV and of global PV regulations, including FDA, EMA, MHRA, PMDA, and Health Canada.

• Excellent collaboration and interpersonal skills, an 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.

• Strong analytical skills, an ability to synthesize large amounts of data and/or complex issues into consumable, simple messages and develop tangible recommendations and/or actions. Experience working in a matrixed and fast-paced environment and able to manage multiple projects with an ability to creatively resolve issues and mitigate risks.

• Prior experience in global or local PV operational activities in either pre and/or post marketing environments.

• Prior experience supporting optimization and/or strategic transformation projects

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!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. 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 and approval 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 autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven 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 persons 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.

-