Celgene Director, Healthcare Compliance International in Summit, New Jersey
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.
Summary / Scope:
The position of Director, International Healthcare Compliance is responsible for leading and executing International compliance projects in support of the Compliance Program. Including design of communication plans, training, process design, governance, and maintenance.
Under the direction of the Exec Director, International Healthcare Compliance, the position is responsible to operationalize Corporate and Healthcare Compliance (“HCC”) 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 ex-US geographies.
Leading key International Compliance Program initiatives including but not limited to enhancing processes for the management of Global Fair Market Value, Fees for Services, or Grants, Donations, Sponsorship Funding.
Driving projects to ensure efficient use of resources, and create synergies across global geographies for Compliance processes.
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, 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.
Maintains a good understanding of developments in applicable HCC legislation, initiatives and enforcement trends for ex-US geographies and actively shares this information across relevant functions.
Assist business owners with training activities in cooperation with Legal on HCC matters.
Ensure regular HCC updates and activity monitoring to the Exec Director, Int’l Healthcare Compliance.
Provide input for the creation and review of Corporate Policies including the creation, implementation and management of business continuity plans.
Support development and implementation of regional and local HCC Policies and Procedures in close collaboration with the business, the cross functional HCC team and Legal.
Manage the compliance training requirements as specified by the risk assessment, and provide regular updates to senior management on the levels of training compliance.
Perform other compliance-related activities as directed by the Exec Director, Int’l Healthcare Compliance.
Degree in Law and/or other advanced degree or certification (CPA, CA, 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.
Additional certifications (e.g., HCC certification, CFE, etc.) will be considered an advantage.
Six (6) to eight (8) plus years of relevant pharmaceutical/biotechnology industry experience, including four (4) to six (6) years of Healthcare Compliance experience (or equivalent) (including anti-bribery/anti-corruption) in the life sciences / pharma industry.
Subject Matter Expert in ex-US geography laws, regulations and industry code requirements
Proven track record for implementing Compliance policies, procedures, and processes.
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 problem solving skills.
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.
Director, Healthcare Compliance International
Location: Summit, NJ, US
Job ID: 17001686