Medical Reviewer Ad/Promo (Part Time, Temporary) - Remote

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.

 

We believe in diversity and inclusion of people of all backgrounds, genders, races, ethnicities, sexual orientations, educational backgrounds, military and veteran status, religions, abilities, and perspectives. MAPS PBC values and seeks applicants who are people of color, queer, transgender, gender non-conforming, and gender fluid people. MAPS PBC strives to establish a supportive, equitable and accessible work environment. 


Medical Reviewer (Ad/Promo) Executive Summary 

 

The primary function of the Medical Reviewer will be to serve as the Medical subject matter expert (SME), providing guidance and feedback during review of promotional, scientific and corporate materials. As a member of the MAPS PBC promotional and medical review teams, the Medical Reviewer will have a strong understanding of FDA regulations associated with prescription drug and medical device promotion, particularly 21 CFR Parts 201 and 202. The Medical Reviewer will ensure that advertising and promotional materials align with product labeling, and claims are well substantiated by clinical data and/or published literature. 


This is a part time, temporary role with intended end date at or near 12/31/2022. 

 

Key Responsibilities 

 

  • Materials Review: Serve as the primary Medical reviewer and approver for MAPS PBC’s Review Committees for promotional, scientific, and corporate materials intended for internal or external audiences. Ensure information reflects strengths and weaknesses of supporting data, medical accuracy, clinical relevance of study methodology, appropriateness of content for the intended audience, and accurate interpretation/use of data. Ensure product or treatment claims demonstrate adequate substantiation and meet defined standards of advertising and promotion. Review materials against clinical data and/or approved labelling to verify accuracy and appropriateness of references and data on file citations.
  • Internal Collaboration: Provide guidance on the development and use of medical and scientific materials including but not limited to medical response letters, presentations, publications and scientific exchange resources. Provide medical guidance on sales training and promotional materials advertised through broadcast, digital media or print, including but not limited to presentations, sales aids, direct to consumer (DTC) advertisements, reminder advertisements and websites.
  • Medical/Clinical Expertise: Maintain strong knowledge of and monitor changes to FDA regulations and guidance surrounding prescription drug and medical device advertising and promotion. Monitor new literature to ensure representation of current citations related to clinical data, medical concepts and disease state facts.

 

Minimum Requirements 

What you bring to the role: 

  • Advanced scientific or healthcare degree or significant healthcare professional experience; MD, PharmD, PhD preferred
  • Minimum 3-5 years of relevant pharmaceutical industry experience as a medical reviewer in advertising and promotion; experience serving as a Medical reviewer during a pre-launch period preferred.
  • Working knowledge of FDA guidance on advertising and promotion of prescription drug and medical devices (in particular, 21 CFR parts 201 and 202), safe harbor, scientific exchange and PhRMA code.
  • Ability to understand and synthesize large amounts of clinical, scientific, technical, and medical information, summarizing data to draw a conclusion.
  • Highly effective verbal & written communication skills
  • Strong ability to work in a remote environment.
  • Experience in CNS, preferred.
  • Cover letter required; incomplete applications may not be considered.

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