Regulatory Affairs and Submission Specialist (RASS)
MAPS PBC advances equity and inclusion in the workplace by providing equal employment opportunity to support a work environment free from discrimination on the basis of race, religious creed, color, national origin, ancestry, physical disability, mental disability, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, sexual orientation, military and veteran status, arrest or conviction record, and any other basis prohibited by law. The organization also provides reasonable accommodations for qualified applicants and employees with disabilities. This equal employment opportunity policy applies to all aspects of employment, including recruitment, selection, advancement, training, problem resolution, and separation from employment. Through this policy, MAPS PBC strives to establish and maintain an equitable and accessible work environment that is supportive and free from discrimination.Call for Candidates:
MAPS PBC is seeking an enthusiastic, focused, and organized person to join our Research Development and Regulatory Affairs department. The RASS will oversee regulatory submission processes involving eCTD, non-eCTD electronic-only submissions, and administrative processes (e.g. filing, corresponding tracking, etc.). Frequent drafting and review of regulatory submission documents (protocols, meeting requests, etc.) will be done as necessary. The RASS must be creative and enjoy working within a small, entrepreneurial environment that is mission-driven, results-driven, and research-oriented. The ideal individual will have the ability to exercise good judgment in a variety of situations, with strong written and verbal communication, and organizational skills, and the ability to maintain a realistic balance among multiple priorities. The ability to work under pressure to handle a wide variety of activities is also necessary. Suitable candidates are able to work well in a fast environment and are adept at organizing and managing lots of information virtually. Interested and qualified candidates are encouraged to apply online at: https://tinyurl.com/applyMPBC
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.
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 weekend hours may be required with advance arrangement.
This position is non-exempt from overtime.
- Coordinate electronic common technical document (eCTD) submissions to regulatory agencies (FDA, EMA, Health Canada)
- Operate regulatory submission systems including, but not limited to, ARIM, WebTrader, Eudralink, and EudraCT
- Manage the tracking and storage of regulatory documentation, submissions, and communications.
- Compile regulatory documentation data tables from study data output files (SAS and SPSS) and raw datasets (Excel)
- Assist in drafting and review/revision of key regulatory documentation for clinical and nonclinical trials.
- QC statistical output files (SAS & SPSS) and raw data sets (Excel) for inclusion in regulatory documentation data tables
- Regularly perform medical coding of diagnoses and medications (MedDRA & WHODrug)
- Assist in drafting and review of Clinical Study Reports
- Update current safety reporting standards and facilitate submission of safety reports to agencies
- Develop SOPs and work instructions for current medical coding, regulatory, and safety standards
- Manage updates and administration of regulatory submission systems as necessary
- Reports to the Director of Research Development and Regulatory Affairs weekly and participate in regular meetings on the project, department, and organizational level.
- Manage project tasks on Asana and contribute to project management.
Minimum Requirements:A bachelor’s degree is required in Computer Science, Neuroscience, Cognitive Psychology/Science, Data Science, or a similar field. A master’s degree is preferred.
- 2 years of experience and knowledge of electronic common technical document (eCTD) submission processes required
- 1-2 years of relevant experience in big-data methods, research methods, or statistical design and analysis required
- 1-2 years of relevant experience in clinical regulatory writing preferred
- Technical proficiency in reading statistical programming output files (e.g. SPSS, R, SAS, etc.).
- A willingness to stay abreast of the development in the area of professional competence.
- The effective ability to understand requirements in whole and in detail and the ability to perform strong analysis and technical problem-solving skills to investigate, debug, and effectively report issues.
- Strong working knowledge of Microsoft Office 365 Applications (Word, Excel, Outlook, etc.)
- Previous or current experience with Amazon Web Services, Microsoft Office 365, SharePoint, Flow
- Experience using Microsoft Office Applications
- Excellent communication skills
- Embodies discretion and able to handle information with sensitivity and confidentiality
- Familiarity with the GDPR, HIPAA, and other applicable regulatory law
- Ability to work independently and within a team
- Open and clear communicator
- Excellent written and verbal communication skills
- Confident and influential approach
- Self-motivating, able to prioritize and take initiative
- Make informed decisions based on guidance from manager and take responsibility for actions
- Possess sound judgment, discretion and be detail orientated
- Able to lead, motivate and understand the needs of others
- Strong organizational skills with attention to details and timelines
- Able to work quickly in a remote virtual setting
- Computer skills, facility with word-processing and spreadsheet applications
- Coordination and planning of tasks and time management
- Recognize potential obstacles and work within set timelines
- Conscientious and precise delivery of work even when under pressure
- Be proactive in problem solving
- Communicate and collaborate with key players, internal and external staff.
- Check in regularly with Department Director and complete assignments by agreed deadline.
- Document process and provide regular updates.
- Proactively seek methods of improvement, of individual work and project outcomes.
- Proactively work to streamline work flows, build efficiency, security and user interface of various platforms.
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.
To apply, visit https://tinyurl.com/applyMPBC.