Sr. Director, ECP Operations
- Moderna, Inc.
- Cambridge, MA
- Start date
- Mar 26, 2023
- Manufacturing & Production, Operations
- Required Education
- Position Type
- Full time
- Genetown, Best Places to Work
Reporting to the Chief Ethics, Compliance & Privacy Officer, the Sr. Director of ECP Operations will be responsible for further developing Modernas operational compliance and privacy processes necessary for a rapidly growing global organization that is scaling up its commercial presence around the world. This role will work with senior Legal, Commercial, Medical, Clinical, Regulatory, Manufacturing, Development, IT, Finance and HR leadership to integrate appropriate compliance and privacy controls to guide the Companys operations and growth.
Heres What Youll Do
Develop and support compliance program framework that enables consistency with the US OIG Compliance Program Guidance for Pharmaceutical Manufacturers (OIG Guidance).
Maintain and analyze program metrics, leveraging data and digital capabilities to advance compliance program effectiveness.
Member of Compliance Leadership team
Establish and maintain policies, procedures, and systems to foster compliance with healthcare fraud and abuse, privacy, and transparency reporting laws, as well as industry codes, such as the Food, Drug and Cosmetics Act (FDCA), Federal Anti-kickback Statute, Federal False Claims Act, Health Insurance Portability and Accountability Act (HIPAA), EU General Data Protection Regulations (GDPR), U.S. Open Payments, state laws.
Develop processes and provide compliance oversight and participate, as required, in review and approval processes for core Commercial and Medical, including R&D activities: including grants, sponsorships, advisory boards and other initiatives involving interactions with healthcare professionals, healthcare organizations and patients/advocacy groups.
Conduct periodic internal reviews, including developing risk assessments and monitoring plans, to ensure that compliance policies and procedures function as intended and the Company identifies potential compliance risks to remediate where necessary.
Support compliance investigation process, including partnering with internal (e.g., Legal, Compliance, and Human Resources) and external (e.g., outside counsel or investigators) stakeholders to address and resolve matters (including, conducting investigations, proposing resolutions and documenting process).
Institute and maintain effective compliance communication channels, including managing Speak-Up line (Compliance Helpline), as well as other means for employees to report compliance-related concerns or engage with senior leadership.
Develop, manage, and execute an annual Global ECP Workplan, including functional objectives, strategic priorities, and operating budget.
Implement a transparency reporting program in compliance with the Federal Open Payments Program and relevant state and country laws.
Heres What Youll Need (Minimum Qualifications)
Minimum 12 years of healthcare compliance experience in a life science company leading key elements of a corporate compliance program (policy, training, auditing, monitoring, investigations, risk assessments)
Experience with creating/running a corporate transparency reporting program
Experience managing direct reports
Heres What Youll Bring to the Table (Preferred Qualifications)
Working knowledge of relevant guidelines and regulations in US and globally
Proven experience in balancing country-level operational priorities with global compliance program development imperatives to ensure continuous improvement across multiple functions in a global company
Experience with building privacy programs
Experience building global compliance programs
Advanced degree and/or J.D. from an accredited law school; admitted into practice and in good standing in at least one state
Strong verbal and written communication skills, and an ability to maintain a high level of attention to detail without losing sight of the big picture
Commitment to finding solutions, relationship building, continued learning, proactivity
A curious mindset that allows you to constantly learn and challenge the status quo
Ability to effectively collaborate and influence effectively in a dynamic, cross-functional matrixed environment
Ability to lead multiple projects in a fast-paced environment.
Ability to manage and prioritize multiple matters simultaneously and to respond to rapidly shifting priorities in ambiguous or challenging situations
Demonstrated ability to own projects and consistently meet tight timing requirements and high-quality standards
Proven ability to interact and communicate effectively with individuals from multiple departments at all levels of the organization
Ability to handle confidential and sensitive information using impeccable discretion and judgment
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative
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.
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.#LI-DP1
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.
mRNA is now a turning point in the history of science, medicine, technology, even humankind itself. With this breakthrough discovery, many of the world’s biggest and most challenging medical problems are no longer a question of “how?” but merely a question of “when?”
Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.
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