Cco - Bethesda, MD, United States - Moderna Therapeutics Inc.

Description

The US Regulatory Policy and Regulatory Intelligence Lead will be a strong subject matter expert in regulatory processes, laws, and regulations, with a strong understanding of how regulatory policy is shaped and developed in the US.

This role will manage a highly collaborative function that addresses global policy intelligence gathering, analysis of changes in the regulatory environment, development of policy positions, and creation and execution of advocacy strategies to achieve policy goals, working collaboratively with both internal and external stakeholders to influence the policy environment set by the US Food and Drug Administration (FDA) and global Health Agencies.

This individual will work closely with subject matter experts within Moderna to shape policies around the mRNA platform, assess the impact of regulatory policy on the company's products and goals, ensure unified US Regulatory Strategies across the portfolio.

Defining and delivering a regulatory policy plan for the US that addresses current and future business needs, that is co-designed with Global Regulatory Sciences, Safety and Pharmacovigilance, Clinical Development and the Quality leadership and in partnership with our company's policy teams at the global, regional and country levels;

Propose – and respond to – draft legislation, regulations, guidelines and policiesat the US level, as well as plan and manage interactions and communications with trade associations and health authorities on regulatory policy matters in the US.

Represent effectively Moderna's position in the US and serve as the company representative internally and externally on key US policy topics to appropriately shape the regulatory environment with US FDA (e.g. interact with the FDA and engage in proactive policy activities policy topics, such as real world data, digital health, rare diseases, pediatrics, diversity in clinical trials, patient focused drug development, PDUFA) as well as engage with patient advocacy organizations, medical societies and key industry stakeholder such as DIA, BIO, etc.
regulatory milestone meetings, management "meet and greets", ad hoc policy-focused meetings) as assigned for specific projects.

Providing insights and advocate for positionson critical regulatory issues and trends to Research and Development business partners and to contribute to a broader policy platform; Build our company's share of voice and influence extramural to support the enterprise policy agenda through engagement in trade associations and representation for industry initiatives.

Oversee and manage regulatory Intelligence resources and databases as well as access to them, and provide focused regulatory insights to the GRS organization and other stakeholders.

Bachelor's Degree is required, preferably in science, health care, public health or health policy or BS in any field accompanied by a Masters or Doctorate degree in science, health care, public health, health policy, or law;
Bachelor's degree and at least 15 years of experience with FDA, either directly (working within a health authority) or indirectly (closely interacting with health authority);
Deep understanding of the US regulatory environment, the Food, Drug and Cosmetic Act and latest regulations and guidance's with sound knowledge of intelligence tools and methods; preference will be given to candidates with experience supporting vaccines and infectious disease products, and experience across a number of disciplines including Pharmacovigilance, Quality, and Clinical Development;
Ability to fully demonstrate our company leadership principles, driving results and building talent;
Ability to travel internationally;
Excellent command of English (written and spoken).
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
~ Exclusive preferred pricing on Peloton fitness equipment
~ Dedicated care coordination support for our LGBTQ+ community
~ Vacation, sick time and holidays

• Volunteer time to participate within your community
• D iscretionary year-end shutdown
• Paid sabbatical after 5 years; 401k match and Financial Planning tools

~ Complimentary concierge service including home services research, travel booking, and entertainment requests
~ 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 people are 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.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.

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.

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. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities.