Associate General Counsel - Remote

MAPS PBC is pioneering a new form of mental health care, beginning with the development of MDMA-assisted therapy as an FDA-approved treatment for PTSD.  MDMA-assisted therapy is a new paradigm in the treatment of mental health, combining a medicine with psychotherapy to address the root causes of PTSD. It has been designated a Breakthrough Therapy by the FDA and the results of our pivotal Phase 3 clinical trial were published in  Nature Medicine and profiled on the front page of The New York Times .  

 

MAPS PBC is a Public Benefit Corporation, with a dual mandate to generate shareholder value and public benefit. We are a wholly owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit working for over three decades to develop medical, legal, and cultural contexts for people to benefit from psychedelics. We are committed to continuing to lead the field of psychedelic medicine with integrity and ethics at the core.  

 

Why work for MAPS Public Benefit Corporation (MAPS PBC)?  

 

  We are a diverse team that shares a deep belief in the critical need for innovation and expanded access in the treatment of mental health conditions.

  We are entrepreneurial, collaborative, and open-minded in how we approach our innovative work. 

  We are a new kind of pharmaceutical company that prioritizes public benefit over profit and is committed to sustainability, accountability, and transparency. 

 

MAPS PBC is seeking an experienced and talented attorney with strong healthcare or pharmaceutical experience who is driven to the vision of advancing innovative mental health care solutions. The Associate General Counsel reports to the GC and is responsible for providing regulatory, contracting, and general legal support to the General Counsel and the Company's various departments.

The AGC will develop a thorough understanding of and familiarity with the Company's business, product, and operations and apply that knowledge in providing legal guidance and counsel to internal clients. This individual will provide day-to-day counseling/advice and contracting support regarding a wide range of activities and programs related to the Company's current and planned operations including clinical operations, expanded access, investigator-initiated studies, medical affairs, market access, and commercialization. 

Key Responsibilities:

• Oversee contract administration in addition to reviewing and negotiating various contracts including master service agreements, consulting agreements, media, spokesperson, social media influencer, data sharing, and market research agreements; Assist with other contracting-related matters and special projects across the legal function, as determined by business needs.  Researching prior contracting relationship with contracting parties.
• Medical Legal Regulatory (MLR) review
• Ensuring company-wide compliance with Company's contracting policy.  Managing contract management team.
• Acting as a liaison between Company, internal business partners, and outside vendors to facilitate contract execution.
• Building and maintaining relationships with business partners.
• Engaging with other functional areas within the Company to assess and respond to contracting needs, obligations, and revisions.
• Coordinating workflow between the legal department and other departments at the Company.
• Review sales and marketing initiatives and provide operational guidance.
• Identify and communicate legal risks associated with business activities; collaborate cross-functionally to proactively manage risks by understanding business goals and developing solutions with partners to achieve those goals.
• Maintain a deep and current awareness of evolving regulatory and enforcement environment, including FDA and OPDP regulations, advisory comments, enforcement actions and policy developments.
• Handle miscellaneous legal matters as may be assigned by the General Counsel.
• Demonstrate leadership within business and legal teams by seeking to improve ways of working with an eye towards gaining efficiencies.

Minimum Requirements:

• J.D. degree, as well as membership in good standing of at least one state bar.
• At least 5 years of legal experience, preferably with a pharmaceutical or biotechnology company, or in the life sciences practice group of a law firm.
• A solid working knowledge of pharmaceutical research, development, sales and marketing practices, contracts, as well as the statutes, regulations and guidance documents applicable to these activities (e.g., the Food, Drug and Cosmetic Act, regulations and guidance documents; federal and state anti-kickback statutes, regulations and OIG guidance documents and opinions, PhRMA Code, and related policies and guidelines).
• Strong attention to detail.
• Solid presentation skills, and experience learning new subjects quickly and effectively.
• Able to calibrate risk effectively for clear and consistent decision-making.
• Good general working knowledge of key contracting issues and negotiation practice.
• Ability to manage multiple tasks simultaneously and flourish in a fast-paced environment.
• Ability to interact in a professional manner with employees at all levels of the organization.
• Strong written and verbal communications skills, including the ability to communicate concisely, to integrate legal and business knowledge and to provide balanced advice regarding risks. Proficient with Microsoft Office suite of products.
• Ability to travel within the US of up to 10%.
• Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

MAPS PBC is a distributed team that uses technology and periodic in-person gatherings to stay connected. We look for people who are comfortable with and skilled at remote work and collaboration.