Senior Manager, Healthcare Compliance, Auditing Summit United States,
The Sr. Manager, Healthcare Compliance, Auditing, will plan, conduct and follow up on HCC audits of assigned entities to assess compliance with regulatory and Celgene requirements. They will identify compliance risks and drive concurrence regarding their severity and contribute to planning and operational analyses for discipline. The scope includes internal and external audits of global sites/affiliates, processes and vendors
- Remain informed of developments in applicable HCC Rules and enforcement trends
- Serve as subject matter expert and provide expertise and advice to business partners regarding HCC issues
- Plan and independently execute audits to evaluate compliance with HCC Rules
- Design and deliver meaningful, accurate and effective presentations to senior management and ensure follow-up on any areas that require corrective action
- Manage and maintain the HCC audit observation and remediation plan database
- Assist in the development of the annual risk assessment and audit plan
- Contribute to the development, implementation, and maintenance of Standard Operating Procedures
- Partner with Global Compliance, Legal, Internal Audit, and Finance teams in carrying out audit activities
- Multi-task required work for the role in addition to leading, managing, and executing ad-hoc compliance projects as assigned
- Supervise and provide guidance to unit colleagues beyond just a team/audit/project setting.
- May mentor colleagues and be viewed as a leader/mentor
- Significant domestic and international overnight travel required, up to approximately 25%
- Completed Bachelor’s degree from an accredited undergraduate institution required.
- 10+ years of healthcare compliance (“HCC”) auditing experience with a global life sciences company or accounting/consulting firm with emphasis in life sciences.
- Currently possessing at least one of the following audit certifications: Healthcare Compliance Certification; CIA; CPA; CFE.
- Extensive knowledge and understanding of applicable HCC laws and guidance; including but not limited to OIG guidelines, AMA guidelines, PhRMA Code, Corporate Integrity Agreements, and global anti-bribery/anti-corruption laws, including but not limited to the FCPA.
- Demonstrable knowledge and understanding of all applicable HCC Rules
- Considers and incorporates global perspectives and requirements
- Proven ability to build and execute audit plans and conduct HCC audits with minimal supervision
- Proven ability to lead cross-functional and diverse teams and participate constructively in multi-discipline teams
- Strong project management skills; drives execution
- High level problem solving, discretion/judgment, detail-oriented and confidentiality; comfortable with ambiguity and can adapt style and tactics based on situation
- Strong interpersonal skills; must be able to forge strong relationships with all levels of the organization
- Ability to effectively prepare and present analytical written and oral communications appropriate for multiple audiences and levels within the organization
- High level of influencing skills and ability to drive change as it relates to implementing remedial actions; balances diplomacy and respectfulness with assertiveness
- Currently possessing more than one of the following audit certifications: Healthcare Compliance Certification; CIA; CPA; CFE
- Completed graduate degree in a field directly-related to the business needs of this position and/or an MBA or JD
- Experience in consulting firm advising on Pharmaceutical industry HCC related issues and implementations
- Experience in Regulatory Affairs, FDA, or pharmaceutical Sales and Marketing, IT and financial auditing also a plus
- Experience with Oracle, Basware, Concur, TeamMate, Tableau, and/or Qlikview a plus
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