Regulatory Medical Writer - Remote Position

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

About MAPS Public Benefit Corporation (MAPS PBC): 

MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and well-being through psychedelic drug development, therapist training programs, and sales of prescription psychedelics prioritizing public benefit above profit. Founded in 2014, MAPS PBC is a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS) a 501(c)(3) nonprofit.   

 

More information about the organization is available at http://www.mapspublicbenefit.com 

 

MAPS PBC is committed to the evolution of psychedelic healing modalities. We are building a diverse and inclusive workplace where we learn from each other.  We value transparency,

autonomy, experimentation, and kind, direct feedback. We welcome applicants who thrive in the midst of a growing organization that values science and healing.  

  

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 continually

improve upon the supportive, equitable and accessible work environment.   

 

Call for Candidates:  

MAPS PBC is seeking an enthusiastic, organized, and flexible team player to join the Regulatory Affairs Department as a Regulatory Medical Writer (RMW).  Reporting to the Regulatory

Affairs Manager, the RMW will be responsible for supporting regulatory document writing to develop the global evidence base for MAPS-sponsored research. The individual in this position functions as the lead writer for documents required to facilitate global regulatory programs across regions and business units.  The ideal RMW has a strong scientific background in biological science and excellent writing skills. The position also requires understanding of the clinical development program, relevant scientific literature, and regulatory goals to drive scope and 

direction of data-driven summaries. The RMW must enjoy working within a small, entrepreneurial environment in which the ability to work under pressure and to handle a wide variety of

activities is necessary.  Suitable candidates must be 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.


Location:  

This is a remote position from a suitable home office with a private and quiet area to work. Secure internet and reliable phone reception are required.


Hours: 

Full time, exempt salaried position. Must be available during normal business hours for a California-based company. Occasional evening/weekend hours may be required. 


    Position duties: 

    • Authors high quality clinical and regulatory documents including but not limited to: 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).  
    • Reviews and formats documents to produces high quality documents consistent with company style guide and regulatory authority standards while maintaining organization,              formatting  and style properties and conventions  
    • Participates in developing global medical writing strategy   
    • Takes responsibility for ensuring timely execution of medical writing strategy and operating plans. 
    • Regularly reports to supervisor on progress against objectives and plans.  
    • Plans and leads cross-functional clinical writing projects  
    • Provides technical guidance to project teams and assists with interpretation/presentation of clinical efficacy and safety data   
    • Reviews existing scientific literature, and writes clinical, data-driven summaries when requested.  
    • Develops and applies best practices in compliance with established regulations and standards, including but not limited to FDA, EMA, and ICH E3 and E6 guidelines, and ensures that  company documentation meets with these standards.    
    • Works closely with Regulatory consultantsClinical DevelopmentData Science, and Biostatistics to organize input from key stakeholders and communicating large amounts of       information.  
    • Researches and sources appropriate medical literature for medical writing, regulatory response, and data analytical projects and proposals utilizing various information sources. 
    • Revises content and materials to improve accuracy, style, content or focus. 
    • Contributes to manuscripts for submission to peer-review journals, conference abstracts, posters and presentations as needed.   
    • Contributes to development of public research disclosures in support of the company’s commitment to open science as needed. 
    •  A bachelor’s degree in related scientific field is requiredAn advanced degree is preferred. Preference for background in biological science or medicine (with a focus on CNS) with a       strong interesting in clinical research.
    • 2-3 years of professional experience as a medical writer in the pharmaceutical, biotech, or medical device industry  
    • 2-3 years of relevant experience in clinical trials, research methods, or statistical design and analysis. 
    • Proficient knowledge of medical terminology, psychiatric diseases, pharmacology, pharmacodynamics, and research 
    • Strong understanding of statistical testing and data interpretation and high level of numeracy, specifically in the interpretation of statistical analyses of scientific data 
    • Knowledge of and ability to describe highly technical research methodology and results (including clinical investigation design and biostatistics) in written format  
    • Strong understanding of global regulatory requirements that pertain to clinical trial conduct and medical writing 
    • Experienced in searching relevant data bases (e.g. PubMed and Medline) to be able to complete through systemic literature reviews and clinical summaries  
    • Working experience with clinical outcomes research study design 
    • Advanced proficiency for critical business software and cloud based systems, including Microsoft Windows, Microsoft Office 365 Applications (Word, Excel, PowerPoint, Outlook, etc.)OneDrive, Adobe Professional, and SharePoint.  
    • Strong knowledge of Good Clinical Practices, ICH guidelines, European Medicine Agency practices, Good Publication Practices, and global clinical regulations, including FDA regulations  
    • Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide. 
    • Ability to self-manage workload, project manage cross-functional documents, and meet aggressive timelines 
    • Possess sound judgment, discretion, and strong critical thinking skills to make informed decisions based on general guidance.  
    • The ability to work both independently and as part of a team. 
    • The ability to maintain high-quality work while meeting tight deadlines. 

     

    Additional Competencies:  

    • Extensive knowledge of applicable clinical trial regulatory requirements in U.S. and EU 
    • Experience in medical communications or healthcare agencies 
    • Strong interpersonal skills that can be used to effectively collaborate on work with other technical personnel 
    • Demonstrates a result-oriented mindset, determination, ownership of responsibility, reliability, and accountability, while still working cohesively as a team member and following            direction as part of a team under general supervision.  
    • Demonstrated ability to identify issues and implement solutions, including identifying and involving the appropriate decision makers.  
    • Recognize potential obstacles and work within set timelines. 
    • Conscientious and precise delivery of work, especially when under pressure. 

     

    General Responsibilities: 

    • Communicate and collaborate with key players, internal, and external staff.  
    • Check in regularly with manager and complete assignments by agreed deadline.  
    • Follow SOPs and work instructions for regulatory and safety processes of MAPS PBC. 
    • Document processes and provide regular updates. 
    • Proactively seek methods of improvement for both individual work and project outcomes.   
    • Proactively work to streamline workflows, troubleshoot and build efficiency 
    • Participates in regular meetings at the project, department, and organizational level.  
    • Manage project tasks in project management platforms such as Asana and Smartsheet.  

     

    Compensation:  

    • This position is exempt from overtime. Salary available upon request.  

    Thank You

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