Overview

The Director, Compliance and Ethics-Global Medical Affairs and Business Development will serve as the Compliance Business Partner  to various teams and projects as assigned within the Global Medical Affairs and Business Development functions, with specific emphasis on Medical Science Liaisons (“MSLs”) and Health Care Provider Engagements conducted by the GMA organization (e.g. advisory boards and consultancies).  This role will provide support for all potential business development deals, including compliance risk assessments and due diligence, reporting findings and the creation of risk mitigation plans.  This role will be responsible for managing the development of policies and training as they relate to the Global Medical Affairs Organization.

Responsibilities:

  • Lead business partner globally for the Medical Science Liason Role;
  • Lead business partner for all business development/ mergers and acquisitions activities;
  • Developing compliance policies and training in response to risk assessments or identified gaps within GMA;
  • Provide compliance guidelines and assessment of HCP ad boards and consultancies in supported groups ;
  • First line support for Investigator Sponsored Research and Collaborative Research Studies
  • Support compliance investigations as assigned;
  • Develop and maintain knowledge and understanding of: Alexion products, industry regulations and guidelines (e.g. Federal Anti-Kickback Statute, False Claims Act), Sunshine Act, Alexion policies, procedures, and guidelines and regularly communicate substantive developments to business partners.

Qualifications:

  • 10- 15 years of professional experience (5-7 of which should be in the pharmaceutical industry in either Compliance, Regulatory, Medical Affairs, or Legal)
  • Up to 20% travel
  • Excellent written and verbal communication skills and organization skills are required
  • Must possess an in-depth knowledge and understanding of pharmaceutical industry regulations and guidelines (e.g. FDA, PhRMA Code, Federal Anti-Kickback, False Claims, etc.)
  • Previous experience in conducting training, audits or investigations
  • Must possess an in-depth knowledge and understanding of pharmaceutical sales, marketing, and/or product related practices
  • BA/BS degree required
  • JD or MBA preferred

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