Postdoctoral Research Fellow, Praxis, Precision Medicines, Regulatory & Medical Affairs

About the Opportunity

Job Summary:

The Northeastern University Fellowship Program provides a dynamic academic environment offering fellows the opportunity for a wide breadth of experiences:

• Develop teaching skill through participation in our Teaching and Learning Seminar series
• Facilitate small and large group didactic education in partnership with a faculty mentor
• Utilize a layered learning model in experiential education by co-precepting students on pharmacy practice experiences including Northeastern’s unique co-op program
• Create, present, and publish scholarly research through collaborative industry and university relationships
• Engage with faculty who participate in various interdisciplinary graduate programs including biotechnology, nanomedicine, immunology, health informatics, and drug discovery
• Network with area residents and other Northeastern fellows via professional development programs, teaching seminars, and participation on fellowship committees

About Praxis

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders, or CNS, characterized by neuronal excitation-inhibition imbalance.  Praxis is applying insights from genetic epilepsies to both rare and more prevalent neurological disorders, using our understanding of shared biological targets and circuits in the brain.  

Trust, Ownership, Curiosity, and Results are foundational in every aspect of our business and are exemplified by each one of our team members.  We Dare for More in every aspect of our journey, from the patients we are working for, to the portfolio we build and advance every day, and to ourselves and our relationships.

Regulatory & Medical Affairs

The 2023-2025 fellowship program is the inaugural partnership between Praxis Precision Medicines and Northeastern University to offer a unique fellowship opportunity that can be performed remotely with travel to the Boston area. The program is designed to equip postdoctoral PharmDs with the skills necessary to develop the advanced therapeutics of the future. The goal is to cultivate the future leaders of biotechnology and allow fellows to pioneer new therapies for patients.

Praxis fellows are grounded in their core expertise area but utilize the fellowship’s flexibility to branch out and discover other opportunities throughout the organization with personalized rotational experiences. Part of the backbone of the fellowship program is the Northeastern University teaching opportunities which allow fellows to share their knowledge in an educational setting.

Regulatory Affairs and Medical Affairs at Praxis are part of the medical organization with diverse scientific, technical, and clinical expertise. The team is responsible for creating and implementing innovative strategies to support expedited drug development and approval of Praxis’ products. Assuming increasing responsibility over the two years, the Regulatory & Medical Affairs fellow will interface with Praxis leadership team, gaining hands-on experience and participating in unique opportunities within the CNS space.

Proposed Timeline

• Rotation-based program
  • 12-months, Regulatory (1 July 2023 – 30 June 2024)
  • 12-months, Medical Affairs (1 July 2024 – 30 June 2025)

Responsibilities – Primary:

• Regulatory Affairs
  • Gain experience working on programs that span the entire development lifecycle
  • Understand and develop knowledge in three focus areas of Regulatory, Regulatory Strategy, Regulatory operations and Regulatory CMC
  • Understand the fundamentals of both US and global regulatory
  • Develop skills in Medical Writing
  • Understand how the study-level documents are created and how individual studies support the overall drug development process
  • Understand the New Drug Application and approval process
  • Familiarity with FDA Guidance database and Code of Federal Regulations
• Medical Affairs
  • Understand various roles, processes and industry standards involved in the US Medical Affairs
  • Assist in the development of medical brand plan and disease state programs
  • Assist in the creation of medical information response documents
  • Be an active contributor to the team to develop/launch medical strategies within the Medical Affairs Teams
  • Contribute to the review of promotional and medical materials
  • Work closely with Medical Affairs team to develop training and scientific education for internal and external stakeholders
  • Collaborate with cross-functional teams (regulatory, legal, clinical development) to provide and communicate the most up to date scientific information Learn how to develop strategic scientific communication plans, as well as medical congress planning, in a cross-functional manner
  • Partner with Medical Directors /Health Economics Directors to develop scientific materials that align with the scientific communication materials that align with the scientific communication plan (e.g. manuscripts, abstracts, posters, slide decks).

Qualifications:

Doctor of Pharmacy degree from an ACPE accredited institution, eligible for licensure as a pharmacist in the State of Massachusetts.

Excellent oral and written communication, time management, and leadership skills, ability to work independently and take initiative on a variety of projects at Praxis and Northeastern.

Additional Requirement:

To safeguard the health of our employees and their families, our partners and visitors, and our communities, Praxis requires that all employees be up-to-date on their COVID-19 vaccinations, including CDC recommended booster shots. Employees must provide proof of such vaccinations before beginning employment, except where prohibited by law.

Additional Information:
 Applicants should submit the following APPLICATION MATERIALS by the priority deadline of October 31st, 2022:

• Curriculum vitae (CV), uploaded
• Unofficial PharmD transcripts, uploaded
• Cover letter, uploaded

Three formal letters of recommendation (LORs) sent directly from the letter writer to PharmDFellowships@northeastern.edu by November 28th, 2022. LOR writers should include the candidate’s name and fellowship program(s) in the subject line (e.g. Smith, John – GSK).

Address cover letter and three LORs to:

J. Andrew Orr-Skirvin, PharmD, BCOP

Clinical Professor, School of Pharmacy

Chair, Department of Pharmacy & Health System Sciences

Director of Pharmaceutical Industry Fellowship Program

360 Huntington Ave, 140TF R218

Boston, MA 02115

Position Type

Research

Additional Information

Northeastern University is an equal opportunity employer, seeking to recruit and support a broadly diverse community of faculty and staff.  Northeastern values and celebrates diversity in all its forms and strives to foster an inclusive culture built on respect that affirms inter-group relations and builds cohesion. 

All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, religion, color, national origin, age, sex, sexual orientation, disability status, or any other  characteristic protected by applicable law.

To learn more about Northeastern University’s commitment and support of diversity and inclusion, please see www.northeastern.edu/diversity .