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Medical Compliance Specialist

This job is no longer available

Bethesda, MD, USA
Full-time

The Medical Compliance Specialist works as part of a team and, under direction, is responsible for: 1) coordinating with the Grants and Contracts Office to negotiate CFF Terms and Conditions of Award with domestic and international awardee institutions; 2) tracking patent and intellectual property matters arising from academic awards; and 3) interfacing with the Grants and Contracts Office on all other compliance matters.  Reporting to the Medical Compliance Manager, the Medical Compliance Specialist, serves as the main point of contact for Awardee Institutions for negotiation of Terms and Conditions of Award as well as other compliance-related issues affecting the Grants and Contracts Office.  Awards range from basic science awards, Care Center awards, and clinical research awards.

Areas of Responsibility: 
  • Evaluation and negotiation of CFF Terms and Conditions of Award, with appropriate escalation of issues to Medical Compliance Manager and Chief Legal Officer.
  • File management and maintenance of CFF Terms and Conditions of Award for over 300 awardee institutions.
  • Negotiate royalty sharing agreements resulting from intellectual property developed with CFF funding.
  • Work with Grants and Contracts team in drafting and revising CFF Terms and Conditions of Award.
  • Work efficiently and communicate effectively with the Senior Vice Presidents of Research Affairs, Therapeutics Development, and Clinical Affairs, as well as the Chief Legal Officer and other leadership.
  • As part of the Medical Compliance Team, understands overall compliance issues and contributes to team efforts as necessary.
Educational Background: 
Bachelor’s degree required, paralegal experience or JD preferred.
Skills/Experience: 
  • Able to take initiative, make well-informed decisions, and understand and convey CFF priorities in contract negotiations.
  • Able to communicate effectively in person, on the phone, and in writing with external parties, internal Program and Grant Officers and with staff at all levels of the CF Foundation.
  • Strong computer skills, including the use of Microsoft Office Suite.
  • Able to organize priorities during levels of high demand and meet deadlines; able to maintain related electronic and paper records.
  • Must be able to demonstrate attention to detail and accuracy; understand how to escalate issues and follow through to resolution.
  • Works together as part of a team.
  • Aware of applicable regulations and able to apply them to daily work processes.
  • Experience in grant-making environment preferred.
  • Relevant experience in negotiation of contracts or other legal documents.
  • Adept at use of Microsoft Office Suite.
  • Two years of relevant work experience or related education.
Job Function: 

Organization Info

Cystic Fibrosis Foundation

Overview
Headquarters: 
Bethesda, MD, United States
Founded: 
1957
About Us
Mission: 

The mission of the Cystic Fibrosis Foundation is to cure cystic fibrosis and to provide all people with the disease the opportunity to lead full, productive lives by funding research and drug development, promoting individualized treatment and ensuring access to high-quality, specialized care.

The Cystic Fibrosis Foundation has 70 chapters and branch offices across the country that work diligently to raise funds to help support the search for a cure. In addition, the Foundation provides funding for and accredits more than 120 CF care centers and 53 affiliate programs nationwide, including more than 100 programs for treating adults with CF. The high quality of specialized care available throughout the care center network has led to the improved length and quality of life for people with CF. Located at teaching and community hospitals across the country, these care centers offer the best care, treatments and support for those with CF.

Listing Stats

Post Date: 
Oct 3 2019
Active Until: 
Nov 3 2019
Hiring Organization: 
Cystic Fibrosis Foundation
industry: 
Nonprofit