New England Research Institutes
  • 26-Jan-2017 to 26-Aug-2017 (EST)
  • Full Time

New England Research Institutes (NERI) was founded in 1986 and has grown to become a research organization with a global reputation for high-quality research, innovative thinking, and the use of state-of-the-science tools and techniques. NERI continues to be a leader in public health research, clinical trials management, epidemiology, and state of the art media and dissemination research.

NERI's uninterrupted growth and success has been driven by strong leadership, disciplined attention to scientific integrity, and its ability to attract and retain exceptionally talented staff members.

 This is a part time position working 20 hours a week from our Watertown office. Hours are flexible!

 

Essential Duties and Responsibilities:

The Clinical Regulatory Affairs Specialist will manage regulatory aspects of complex projects, including major applications submitted to regulatory agencies.  This role would be in charge of compliance, IND application submissions as well as communication with the FDA.    Additional responsibilities as follows:

 

  • Manage regulatory support for project teams in pharmaceutical, device, and biologic products, both domestically and internationally
  • Plan and create documentation packages such as IND, IDE, NDA, PMA, 51O(k), BLA/PLA submissions, including international equivalents
  • Liaison between government regulatory authorities to facilitate the review and approval of regulatory applications/submission
  • Negotiate complex regulatory issues pertaining to applications
  • Review documentation/submissions from departments outside of Regulatory Affairs
  • Advise project teams on regulatory acceptability of plans for drug/device/biologic development
  • Provide interpretive analyses of regulations, directives, and regulatory guidance
  • Review, edit and write technical documents
  • Develop training modules consistent with institutional needs and in accordance with current international GCP requirements
  • Reviews all functional group SOP's

 

Education and/or Experience

  • BS/BA with 6-8 years' experience or a MS with 5+ years' experience in pharmaceutical, medical device, biotechnology regulatory-related clinical research.
  • Strong FDA and drug experience required
  • Strong technical writing skills
  • Effective project management techniques

 This is a part time position working 20 hours a week from our Watertown office. Hours are flexible!

LOCAL CANDIDATES ONLY

ERI is an Equal Opportunity Employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identify and expression, age, disability, Vietnam era or other eligible veteran status, or any other protected factor.

 

 

New England Research Institutes
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