Director, External Funding Compliance

Employment Type

: Full-Time


: Miscellaneous

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Position Summary The Director, External Funding Compliance will serve as the process owner and compliance business partner to all functions involved in the External Funding process (e.g. Global Medical Affairs, Patient Advocacy, Corporate Social Responsibiity etc.) . In collaboration with appropriate business functions, this role will assist in the creation of governance around the External Funding process such as establishing organizational giving priorities, setting budgets, and evaluating requests for external funding consistent with organizational priorities. This role will be responsible for managing the grants review system, developing, updating and maintaining expertise on interal policies and SOPs, as well as demonstrating a strong expertise on the compliance risks associated with external funding activities. This role will maintain a focus on the external environment, ensuring that our policies and practices reflect industry standards and guidelines. This role will convene and lead regular meetings of the various review committees, create and drive the agenda, document decisions and serve as a key contact to manage communications to external applicants. This role will be responsible for continued process improvements and training of all stakeholders on the system, review process and their respective roles relative to each type of funding request. This role will also interface with the broader Compiance Department to help identify issues or concerns requiring local compliance input. This position requires a skilled professional who demonstrates: Technical acumen in managing a web-based review system Compliance knowledge of issues impacting funding requests in the pharmaceutical industry Courage to speak up and raise concerns and openness to feedback from others Attention to detail in performing initial application reviews for completeness Organizational skills Excellent written and verbal communication skills Effective meeting management Influencing skills Principal Responsibilities Manage the Grant Review System Convene and Manage Meetings of Review Committees for each external funding type Developing compliance policies and training for each external funding type Provide initial application review for completeness Raise any compliance issues associated with the external funding request or internal review process Support compliance investigations as assigned; Develop and maintain knowledge and understanding of: Alexion products, industry regulations and guidelines and enforcement environment. Qualifications 10 years of professional experience (5-7 of which should be in the pharmaceutical industry in either Compliance, Regulatory, Medical Affairs, Clinical Operations 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.) Education BA/BS degree required JD or MBA preferred *LI-JD1 New Haven, CT, United States Req ID: 15380Salary Range: NAMinimum Qualification8 - 10 years

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