CMC and Project Management Assistant (CPMA)

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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. 

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 establish a supportive, equitable and accessible work environment.

Call for Candidates

Reporting to the Director of CMC and Project Management, the CPMA assists the CMC and Project Management team with document management, including writing, formatting, version control, change control/tracking, and filing. These activities will support all functional areas covered by the CMC and Project Management team which include: clinical and commercial CMC for regulatory submissions, IMP supplies, IMP logistics, IMP project management and inventory, vendor management, nonclinical toxicology, randomization systems, cross-functional program project management, clinical program project management, cross functional inspection readiness support and NDA project management.

This position works in line with program-wide timelines, including maintenance of those timelines, and in accordance with relevant Standard Operating Procedures (SOPs), the principles of appropriate GxPs, specifically GCP.

This position will become familiar with all aspects of drug development and GxP guidelines and will have the opportunity to work in a team environment. The CPMA must enjoy working in a small, entrepreneurial environment that is mission-driven, results-focused, and research-oriented.

Interested and qualified candidates are encouraged to apply online at: tinyurl.com/applyMPBC

 

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 for frequent phone and internet meetings. Preference will be given to applicants living on the East Coast.

 

Hours

Applicants must be available 40 hours a week, during normal business hours (9:00 AM – 6:00 PM Monday – Friday). The exact schedule may be arranged upon hire. Occasional night and weekend hours may be required with advance arrangement. Meetings with MAPS PBC in California (PST) are required from time to time.

 

Minimum Requirements

  • A bachelor’s degree preferably in science or a related field
  • 1 year of relevant experience with a strong interest in drug development and clinical research

 

Additional Competencies

  • Ability to work independently and within a team, following the direction of the Director of CMC and Project Management
  • Open and clear communicator with excellent written and verbal communication skills
  • Self-motivated, able to prioritize, take initiative, and work quickly in a remote, virtual setting
  • Possess sound judgment, discretion, and the capacity to understand the needs of others
  • Strong organizational skills with the ability to plan and coordinate tasks, while managing competing priorities and timelines
  • Ability to recognize potential obstacles, and deliver conscientious and precise work even when under pressure
  • Demonstrate a results-oriented approach, determination, responsibility, and accountability

 

General Responsibilities

  • Assist with writing and compiling CMC regulatory submissions, specifically transcribing of data sets, formatting, hyperlinking, and sourcing and indexing appendices
  • Version control and change control/tracking for CMC regulatory submissions, including cross referencing with relevant CMC regulatory minutes and responses
  • Assist with IMP supplies, trial-specific documents formatting, finalization and approval
  • File program, study and site level IMP and randomization related essential documents in the appropriate eTMFs
  • Manage filling system for all (program level non-eTMF) vendor CMC, nonclinical, and randomization documents
  • Administratively support IMP Supply Manager(s) with their documents and trackers/systems as needed
  •  Support the formatting, finalization, and approval of SOPs and related forms
  • Supports eCTD submissions to regulatory agencies using ARIM, Web Trader, Eudralink, and EudraCT
  • Attend vendor project management calls and follow-up related to minutes, action items, and decision logs, as applicable
  • Assist with vendor contracts tracking and program/study budget/cost projections
  • Maintain effective communication with other members of the CMC and Project Management team
  • Participate in team meetings and assist in preparation, calendaring, and management of meeting minutes
  •  Perform any other administrative tasks to support the CMC and Project Management team members as needed

FLSA Status

Non-Exempt (i.e. eligible for overtime)

Compensation

Salary range disclosed upon request. Includes full benefits package.

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MAPS PBC is a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS). MAPS is a 501(c)(3) non-profit research and educational organization.