Senior Manager, Compliance Department - United States
- Our company is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care.
- The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.
- The Senior Manager, Compliance Department will assist in executing aspects of our company's Compliance Program and ensuring full compliance will all applicable laws and regulations.
- This will include maintenance of all written policies and procedures, delivering compliance and policy training across organization, assisting with compliance communication efforts. Position will interact with departments across company and assist in developing tools and resources for our employees to use to understand and follow company compliance policies and procedures.
- Assist with managing the Company’s overall development and delivery of Compliance training to individuals and organizations throughout the company
- Enhance and develop further compliance tools and job aids to assist employees across the organization
- Develop and enhance existing compliance training on-line, live and multimedia offerings
- Work closely with Commercial training to identify product messaging and promotional risks and assist in enhancing on-going product training and support tools
- Oversee approval of third party events and advisory boards with various departments.
- Facilitate remedial action and training based on legal and senior management feedback to clarify areas of confusion and improve overall compliance program
- Assist with enhancing and delivering elements of company’s on-going compliance communication strategy across the organization
- Experience in policy development and healthcare compliance content development and training with 5 to 10 years healthcare, device, and /or biotech experience.
- Knowledge of federal fraud and abuse laws, including FDA/OIG guidelines, Industry Codes and privacy laws.
- Knowledge of the Physician Payments Sunshine Act and aggregate spend reporting requirements
- Medical Affairs, Commercial, or field based training experience is a plus
- Exceptional communication skills, including presentation capabilities, interpersonal skills and conflict resolution
- Negotiation skills requiring exceptional interpersonal communication
- Ability to persuade with verbal and written communications involving multiple client groups
- Ability to maintain an independent and objective perspective while developing and maintaining a strong partnership
- Our company is an equal opportunity employer.
- We are able to offer the opportunity to be part of this successful, fast growing company.
- A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation.