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. This role will assist the broader Compiance Department in ensuring company and individual adherence to Alexion Policies, Guidelines, and Federal and state laws and requirements. Additionally, this role will have responsibilities for:
- Providing compliance advice and support for the Investigator Sponsored Research and Collaborative Study review and approval process;
- Providing compiance support for Scientific Communications Group (including MLR, Publications and Medical Information);
- Providing compliance advice on product labeling issues; and
- Supporting compliance investigations cross functionally as assigned;
- 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.
- 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
Boston, MA, United States
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.
Alexion is an Equal Opportunity /Affirmative action employer