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Sr Dir, US Healthcare Compliance ( Hem/Onc)

Req #: 1700191
Location: Summit, NJ US
Job Category: Regulatory Affairs
Work Location: 86 Morris Avenue CELSUM 07901
Organization: Celgene Corporation
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:US- NJ- Summit East

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

The position of Sr Director, US Healthcare Compliance is responsible for the oversight of the US Compliance Program for the US Hem/Onc Franchise.  Under the direction of the VP, US Compliance Officer, the position is responsible to operationalize Corporate and Healthcare policies and initiatives.  This position requires close collaboration and coordination with other regional HCC teams, Legal, Internal Audit, Healthcare Compliance Audit and other relevant functions.  The position is expected to be a reliable source of information and interpretation of compliance principles and operationalization of compliance requirements for the US Hem/Onc Franchise.

RESPONSIBILITIES INCLUDE:

  • Identifying potential areas of HCC risk and developing plan of action to address those areas of risk, including but not limited to working closely with Legal.
  • Responsible for overseeing the implementation and operationalization of Corporate Policies and Global Procedures for the US Hem/Onc Franchise, including but not limited to assistance with procedural documentation and an understanding of the intent of corporate policies and training.
  • Takes a leading role in establishing and implementing remedial activities for HCC audit findings and interacting and following through with applicable department and functional heads for corrective actions and implementation.
  • Actively participate and acts in the capacity of Secretary for HCC Board meetings to prepare reports, presentations, meeting agendas and minutes of meetings.
  • Represents the Hem/Onc Franchise as an active participant and member of the Corporate Policy Committee.
  • Maintains a good understanding of developments in applicable HCC legislation, initiatives and enforcement trends for the US and actively shares this information across relevant functions.
  • Member/leader of cross-functional teams that perform HCC compliance investigations and investigations on compliance matters referred by the Compliance and Ethics Committee.
  • Assist Business owners with training activities in cooperation with Legal on HCC matters.
  • Ensure regular HCC updates and activity monitoring to the VP, US Compliance Officer and the US HCC Board.
  • Participate in Corporate Policy meetings as the US Hem/Onc Franchise representative. Provide input for the creation and review of Corporate Policies on behalf of the US including the creation, implementation and management of business continuity plans for the US Hem/Onc Franchise.
  • Lead development and implementation of US HCC Policies and Procedures in close collaboration with the business, the cross functional US HCC team and Legal.
  • Manage the compliance training requirements for the US Hem/Onc Franchise as specified by the risk assessment, and provide regular updates to senior management on the levels of training compliance within the US Hem/Onc Franchise.
  • Perform other compliance-related activities as directed by the VP, US Compliance Officer.

QUALIFICATIONS:

  • Minimum of Bachelors DegreeDegree in Law and/or other advanced degree or certification (CPA, MBA).  Candidates without such qualifications will be considered only if they have extensive compensating experience.
  • A post graduate degree in a science-related discipline (as an alternate to a law degree) in combination with a strong background and experience in a life- sciences industry company.
  • Five (5) to Seven (7) plus years of relevant pharmaceutical/biotechnology industry experience, including four (4) to six (6) years of Healthcare Compliance experience (or equivalent)
  • Additional certifications (e.g., HCC certification, CFE, etc.) will be considered an advantage.
  • Subject Matter Expert in US laws, regulations and PhRMA code requirements. 

COMPETENCIES:

  • Demonstrated ability to work cross-functionally and collaboratively.
  • Demonstrated ability to guide implementation of HCC policies.
  • Substantial experience in risk assessment and mitigation.
  • Excellent interpersonal, collaborative and organizational skills.
  • Works independently, yet effectively in a team environment.
  • Ability to focus attention to details and to create and execute implementation plans.
  • Excellent written & oral communication skills.
  • Excellent investigational and QA problem solving skills.
  • Knowledge of most common office software (Microsoft Office)

#LI-POST

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
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