Head, Commercial Legal and Public Policy

04 Jun, 2020

Jobs

Head, Commercial Legal and Public Policy

Moderna
Cambridge, MA

The Role:
The Head, Commercial Legal and Public Policy is a senior member of our legal and compliance team. Reporting to the General Counsel, The Head, Commercial Legal and Public Policy will be responsible for initially providing legal advice to Moderna’s vaccine franchise and handling a variety of commercial and global public policy activities as Moderna seeks to further develop and launch its COVID-19 vaccine. This position will act as lead franchise counsel initially for our COVID-19 vaccine franchise and eventually lead a commercial legal team in support of all vaccine and other products and product candidates, providing legal support to business partners in various departments across the organization, such as Sales & Marketing, Medical Affairs, Managed Markets, Market Research, Business Analytics, Field Training, and Global Marketing. The ideal candidate will have prior experience counseling prescription drug companies on legal issues relating to global marketing and distribution of vaccines, advertising and promotion, scientific exchange, and interactions with health care professionals.

Here’s What You’ll Do:

  • The Head, Commercial Legal and Public Policy will be the Company’s first Public Policy specific role, working to advance and protect the legislative and regulatory interests, and the reputation of the Company.
  • The selected candidate will oversee and provide counsel concerning a broad range of legal issues, including, among other things, application and interpretation of FDA and other global regulations, the False Claims Act, Anti-Kickback Statute and competition law in connection with regulatory strategy, product labeling, promotional and non-promotional activities, medical and marketing strategies, sales compensation, and interactions with patients and healthcare professionals.
  • This role will routinely partner with senior leadership over the assigned therapeutic area and function(s) to incorporate legal advice into brand planning and long-range strategy, including:
  • Provide input into product launch planning.
  • Advise on major brand, commercial, and medical initiatives.
  • Advise business partners on various Commercial and Medical initiatives in a way that advances the company’s strategy while addressing legal risks and protecting the company’s integrity and reputation
  • Provide legal advice and counsel on advertising and promotion strategies and activities, including: the use of social media; dissemination of scientific information; product development and labeling; pharmacovigilance; product liability; healthcare fraud and abuse; and, other matters relevant to the development, manufacture and commercialization of prescription drugs
  • Serve as a member of various cross-functional teams, including the Communication Review Committee, Medical Review Committee, and Label Working Group
  • Act as a subject matter expert on matters relating to healthcare law and related business operations, staying stay abreast of evolving healthcare legislation and regulations and the enforcement landscape
  • Monitor and report to senior leadership on relevant federal and state legislation, political developments and relevant industry issues, and provide briefings on strategies aimed at protecting Moderna, its patients, and its other stakeholders.
  • Advocate for Moderna’s interests before a network of relevant stakeholders, including the U.S. Congress and state legislatures, federal and state agencies, opinion leaders, outside allies, coalitions and trade associations.
  • Educate internal stakeholders (e.g., Legal, Commercial, Regulatory, Investor Relations, Corporate Communications) on legislative and executive matters relevant to Moderna, its patients, and its other stakeholders.
  • Serve as a registered lobbyist for the Company.
  • Manage all of the Company’s U.S. federal and state government affairs and public policy efforts, including working with outside lobbyists and consultants, with the opportunity to build the function and hire additional staff, as warranted.
  • Advise business partners on various Commercial and Medical initiatives in a way that advances the company’s strategy while addressing legal risks and protecting the company’s integrity and reputation
  • Provide legal advice and counsel on advertising and promotion strategies and activities, including: the use of social media; dissemination of scientific information; product development and labeling; pharmacovigilance; product liability; healthcare fraud and abuse; and, other matters relevant to the development, manufacture and commercialization of prescription drugs
  • Serve as a member of various cross-functional teams, including the Communication Review Committee, Medical Review Committee, and Label Working Group
  • Act as a subject matter expert on matters relating to healthcare law and related business operations, staying stay abreast of evolving healthcare legislation and regulations and the enforcement landscape

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

  • JD from an ABA accredited law school
  • Member of a state bar
  • Minimum of 15 years post-JD experience, preferably including both in a law firm and in-house in the biopharmaceutical industry
  • Outstanding ability to effectively communicate sound legal advice to lawyers and non-lawyers alike, coupled with a strong understanding of business needs
  • Excellent analytical and problem-solving skills
  • Experience advising on statutes, regulations, and guidance documents applicable to commercial operations and medical affairs activities, including: research and interpretation of the Food, Drug, and Cosmetic Act; FDA regulations and guidance; federal and state anti-kickback statutes; OIG guidance document and advisory opinions; the False Claims Act; the Sunshine Act; and the PhRMA Code, is highly desired
  • Experience serving on a promotional review committee is highly desired
  • Working knowledge related to federal and key state healthcare laws, international trade, IP protection, federal appropriations, pricing and reimbursement, healthcare transparency laws, market access, healthcare compliance, and other healthcare and corporate issues that impact the biotechnology industry.
  • Self-starter and life-long learner with a strong work ethic, international experience and excellent interpersonal skills who enjoys working collaboratively and cross-functionally on teams, as well as independently
  • Proactively solves problems and makes decisions
  • Thrives in a fast-paced and dynamic environment
  • Is eager to take on new challenges

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:

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The Company’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna 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, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been ranked in the top ten of Science’s list of top biopharma industry employers for the past five years. To learn more, visit www.modernatx.com.

Our Mission:

Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

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.

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Learn more here

Job posted: 2020-06-04