Part Time - Assistant Teaching Professor - Regulatory Affairs - Compliance



Northeastern University

Part Time - Assistant Teaching Professor - Regulatory Affairs - Compliance

Requisition Number: PTFR000380

Division/College: College of Professional Studies

Location: Boston Main Campus

Full-time/Part-time: Part Time

Responsibilities:

Northeastern University's Professional Advancement Network (NU/PAN) invites applications for a half-time, non-tenured track Assistant Teaching Professor annually renewable faculty position for the Graduate Programs in Regulatory Affairs for Drugs, Biologics, and Medical Devices. The successful applicant will teach on-campus and online graduate-level courses within the Regulatory Affairs Program. Instructional areas will focus on legal and compliance aspects of the pharmaceutical, biologic and medical device product commercialization lifecycles from US and international perspectives. In addition, the successful applicant will serve as a subject matter expert (SME) in the following areas:

  • Regulation of biomedical product commercialization from a statutory perspective based on a thorough understanding of the Food, Drug and Cosmetic Act from a legal perspective
  • Compliance requirements for FDA and other global regulatory agency for safety and adverse event reporting
  • Risk Evaluation and Mitigation Strategies (REMS) and other post-marketing commitments required of biomedical product manufacturers
  • Intellectual property law related to the global commercialization of generic pharmaceutical and bio similar products

    This position is not benefits eligible.

    The Master of Science degree in Regulatory Affairs of Drugs, Biologics, and Medical Devices (MSRA) is an innovative academic program within PAN that is designed to help students develop a foundation for professional growth and success. For a full list of courses and the curriculum, click on the “curriculum tab” of the following link:

    http://www.cps.neu.edu/degree-programs/graduate/masters-degrees/masters-regulatory-affairs.php/

    Courses are offered in on campus, and blended formats - Courses are typically 12-weeks in duration, with a few each year held as 6-week intensives. The majority of courses begin in September, January, April, and July.

    The Assistant Teaching Professor is based in Boston, Massachusetts; however, there is a possibility of traveling once or twice a year to our satellite campuses (the College would cover travel and lodging costs). Courses are taught in multiple formats including online, blended and fully on ground in Boston; faculty do have the opportunity for a home office and are not required to be in Boston every day of the week. Faculty enjoy a collegial work environment that allows for work-life balance, and are expected to be available to students, whether in-person or online. Opportunities exist for additional compensation through other non-teaching activities. Faculty contribute to the College's mission through teaching, service and scholarship. The Faculty member will work closely with other program faculty, and report directly to the Associate Dean for Graduate Academic and Faculty Affairs. The unique half-time nature of this position will allow the incumbent to make an impact on the field of regulatory affairs through the training of new and existing regulatory professionals as well as the opportunity to provide academic leadership to the program, while still maintaining their industry involvement. Our courses are designed for working professionals and take place in the evening or online. This coupled with the half-time nature of the position will enable the incumbent to maintain their ‘day job' should they desire.

    Responsibilities:

    This faculty position's responsibilities include teaching approximately 4-5 courses throughout the academic year and providing academic leadership in the program. Academic leadership will include working with the administration and other faculty, who are predominantly part-time, to ensure that the degree curriculum meets professional standards and is consistent with the requirements of the job market. The candidate for this position will demonstrate application of pedagogical practices and, ideally, will have experience teaching online and incorporating distance learning into programmatic and course specific curriculum. Up to 80% of your time will be allocated towards teaching (teaching load is subject to periodic reviews by the unit and college); actual course load may vary with other responsibilities, which include, but are not limited to the following:

  • Teach assigned courses and develop course content and materials. Blackboard certification through Northeastern University Online is required prior to teaching in the program
  • Develop course content and materials in collaboration with Faculty Director, administration and colleagues
  • Participate in committee meetings
  • Participate in faculty recruitment and mentoring
  • Collaborate with administration and colleagues with curriculum development including teaching materials & assessment development
  • Oversee the instruction of specific courses within the curriculum. Responsibilities include selecting instructors, advising on syllabi, and evaluating instructor performance

    Qualifications:

    Required Qualifications:
    • JD (or equivalent) in life sciences or related disciplines
    • At least 7 years of professional Regulatory Affairs and or Clinical Affairs experience within life science industry

    Preferred Qualifications:
    • RAC Certification
    • Two years of teaching at the graduate level
    • Experience with international students
    • Experience in curriculum development
    • Demonstrated leadership skills
    • Demonstrated communication skills, both oral and written
    • Demonstrated problem-solving and interpersonal skills
    • Ability to work collaboratively with others
    • Demonstrated ability to innovate
    • Ability to successfully advocate for new academic initiatives and motivate others to embrace them

    Additional Information:
    Northeastern University is a global, experiential and leading research university, built on a tradition of engagement with business, industry and communities to create a distinctive approach to education, research and service. Boston is vibrant and stimulating and provides exciting opportunities to grow, learn and to make significant contributions. The Professional Advancement Network offers innovative and flexible programs that allow adult learners and working professionals to complete their degrees. PAN offers associate, bachelor’s degree, certificate programs and post-baccalaureate programs in fast-growing fields such as biotechnology, leadership, business administration, finance, project management, information technology and management. Degrees are delivered in full or part-time formats and courses are offered in a variety of on-campus and online options.

    To be considered for this position please visit our web site and apply on line at the following link: Careers@Northeastern

    Northeastern University is an Equal Opportunity, Affirmative Action Educational Institution and Employer, Title IX University. Northeastern University particularly welcomes applications from minorities, women and persons with disabilities. Northeastern University is an E-Verify Employer.




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