Regulatory Affairs · Any City, Any State, California

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 Publishing Specialist (RPS).

 

Reporting to the Regulatory Affairs Manager, the RPS supports functions related to tracking regulatory information and document styling and publishing in eCTD format for regulatory submissions. The individual in this position supports global regulatory programs, projects, and compliance initiatives across regions and business units.

The ideal RPS has a strong technical background and is comfortable learning and navigating the online systems unique to various regulatory agencies, as well as other specialized technologies for research, clinical trials and project management. The position also requires a keen eye for detail and inconsistencies, strong technical capabilities to utilize specialized features of Office including templates, styles, and hyperlinking. The RPS 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 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. This position requires frequent phone and internet meetings. Certain home office expenses may be reimbursed. A work computer will be provided. Priority is placed on applicants based in the Pacific time zone (U.S. west coast). The MAPS PBC headquarters office is located in Santa Cruz, CA. Occasional travel may be required.

Hours:

50% time, 20 hours per week part time position. Possibility to transition to full time after introductory period.  We are a West Coast-based company and applicants must be available during normal business hours (9:00 AM – 6:00 PM Pacific Time, Monday through Friday).

The exact schedule may be arranged upon hire. Occasional evening/weekend hours may be required.

Position duties:

  • Electronic document preparation and submission of electronic common technical document (eCTD) submissions to regulatory agencies.
  • Support Regulatory Affairs in the planning, development, and publishing of submissions.
  • Collect, track, and organize submission components using various document management systems to ensure high-quality and timely final submissions.
  • Ensure tracking and archiving of regulatory documentation lifecycle: submissions, correspondence, and related information for various regulatory applications
  • Compile and submit electronic common technical document (eCTD) submissions to regulatory agencies.
  • Contribute to brainstorming and troubleshooting of technical issues that may impact validation requirements for submission as they arise.
  • Support drafting and review of regulatory documentation for clinical and nonclinical studies.
  • Track and work on multiple projects and protocols simultaneously and effectively.
  • Provides MS Word and PDF document formatting support to ensure consistency with company and regulatory authority submission ready standards. Updates or transfers documents for regulatory submissions to standardized templates meeting regulatory publishing standards.
  • Performs regulatory document formatting in Word utilizing styles, captions, cross-references/hyperlinking, and citation management.
  • Produces high quality documents with a focus on both organizational items (such as: heading numbering, eCTD section numbering, tables, figures, and links), as well as formatting items (such as fonts, margins, spacing, pagination, styles, and document properties).
  • Performs regulatory document conversion utilizing PDF processing and ensuring appropriate bookmarks, internal links, PDF properties, and conversion of files to meet required regulatory publishing standards.
  • QC study data output files and raw datasets into data tables for regulatory documents as needed.
  • Support updates and administration of regulatory submission systems as necessary.
  • Undertake assignments that may require some amount of problem-solving or lateral thinking to complete effectively

Minimum requirements:

A bachelor’s degree is required. A master’s degree is preferred. Preference for background in biological or data science (such as: Computer Science, Neuroscience, Cognitive Sciences, Data Science, or a similar field) with a strong interesting in clinical research.

 

  • 1-2 years of experience with, and knowledge of, electronic common technical document (eCTD) submission processes, or demonstrable ability to quickly pick up and navigate regulatory electronic submission systems.
  • 2-3 years of relevant experience in clinical trials, research methods, or statistical design and analysis.
  • The ability to understand requirements in whole and in detail and the ability to effectively perform analysis with problem-solving and lateral thinking.
  • Ability to quickly learn new computer technology software packages with minimal training, including technical problem-solving skills to investigate, debug, and effectively resolve issues
  • Strong proficiency in to utilizing specialized features of Office (including templates, styles, and hyperlinking) and Adobe Acrobat or other Adobe plug-in PDF-tools.
  • Advanced proficiency for critical business software, including Microsoft Windows, Microsoft Office 365 Applications (Word, Excel, Outlook, etc.), OneDrive, Adobe Professional, and SharePoint.
  • Excellent written and verbal communication skills, especially in communicating technical information and specifications.
  • A willingness to stay abreast of new developments in the area of professional competence.
  • Possess 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 smartly prioritize tasks and take initiative.
  • The ability to work both independently and as part of a team.
  • Excellent written English, including good spelling and grammar.
  • Keen eye and high attention to detail and inconsistencies in copy and style.
  • The ability to maintain high-quality work while meeting tight deadlines.

Additional Competencies:

  • Extensive knowledge of applicable clinical trial regulatory requirements in U.S.
  • Experience working for a clinical study Sponsor.
  • Experience interacting with the FDA, IRBs, or other regulatory agencies preferred.
  • 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.
  • 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 non-exempt from overtime. Salary available upon request.