Medical Writer

Regulatory Affairs · Any City, Any State, California
Department Regulatory Affairs
Employment Type Full-Time
Minimum Experience Experienced

About MAPS Public Benefit Corporation (MAPS PBC) 

 

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. 


Executive Summary
Reporting to the Associate Director of Regulatory Affairs, the Medical Writer plays an important role in the Regulatory Affairs Department supporting regulatory document writing to develop the global evidence base for MAPS-sponsored research. The individual in this position has experience in IND or CSR writing, an understanding of clinical development, relevant scientific literature, and regulatory goals to drive scope and direction of data-driven summaries. The right candidate will enjoy working within a distributed, entrepreneurial-minded environment in which the ability to work under pressure and handle a wide variety of activities is necessary.  

Key Responsibilities

 

  • Authorship of high quality clinical and regulatory documents including Clinical study reports, Clinical study protocols, Investigator Brochures, Investigational New Drug (IND) submissions, responses to regulatory agency requests, clinical summaries, selected publications, annual reports, and summaries contained in the modules of the Common Technical Document (CTD). 
  • Plan and lead cross-functional clinical writing projects: Work closely with Regulatory consultants, Clinical Development, Data Science, and Biostatistics to organize input from key stakeholders and communicate large amounts of information.  Foster effective team communication and collaboration, providing honest and actionable feedback when relevant.
  • Research and source appropriate scientific and medical literature for medical writing to write or revise data-driven and literature supported summaries when requested with accuracy, style and focus.  


Position Requirements

  • Advanced degree in a technical or scientific field with 2-3 years of professional experience as a medical writer in the pharmaceutical, biotech, or medical device industry  
  • IND or CSR writing experience required, lead authorship preferred
  • Proficient knowledge and relevant experience to fluently describe highly technical research methodology and results (including clinical investigation design, medical terminology and interpretation of statistical analyses) in cohesive and persuasive written format.
  • Adept at describing highly technical research methodology and results in written format as well as organizing, managing, and communicating large amounts of information using document management systems, shared workspaces, and other digital tools.  
  • Advanced proficiency with Word, Excel, and Adobe Acrobat Professional and strong aptitude for learning other critical business software.
  • Sound judgment, discretion, and strong critical thinking skills to make informed decisions based on general guidance.
  • Self-driven with strong time management and organizational skills, and the ability to prioritize tasks, and take initiative. 
  • Cover letter required; incomplete applications may not be considered.  



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.  


Competitive benefit package includes: 

  • Paid Time Off (PTO)
  • Sick Time
  • Holiday Pay
  • Employer paid medical, dental, vision, and life insurance (100% covered for employees + 50% for dependents)
  • Employer funded mental health HRA
  • Employer funded SEP IRA
  • FSA/Dep Care
  • Pet Insurance
  • Home Office Stipend
  • Wellness Wednesday/Journal Club/Yoga/Meditation and so much more!



MAPS PBC commits to building a supportive, equitable, and accessible workplace. We believe in diversity and inclusion of people of all backgrounds, genders, races, ethnicities, sexual orientations, educational backgrounds, arrest or conviction record, military and veteran status, religions, abilities, and perspectives.

Thank You

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  • Location
    Any City, Any State, California
  • Department
    Regulatory Affairs
  • Employment Type
    Full-Time
  • Minimum Experience
    Experienced