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Associate Manager, Healthcare Compliance, International

Req #: 17001762
Location: Summit, NJ US
Job Category: Regulatory Affairs
Work Location: 86 Morris Avenue CELSUM 07901
Organization: Celgene Corporation
Schedule: 40
Shift: Day Job
Employee Status: Full time
Job Type: Regular
Job Level: Manager
Travel: Yes, 25 % of the Time
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.

Summary / Scope:  

The Associate Manager, Healthcare Compliance International position is responsible for coordinating, tracking, and executing International compliance projects in support of the Compliance Program. Including communication plans, training, process design, governance, and maintenance.Under the direction of the Sr. Director / Director Healthcare Compliance, International, 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.

Core Responsibilities:

  • Management and coordination of operational activities for the International Healthcare Compliance team, including support of regional team initiatives.
  • Organizing, tracking and maintaining the status of implementation plans across multiple work streams.
  • Responsible for the maintenance of HCC processes including but not limited to the management of Waiver/Deviation process, Global FMV, Quality Systems, tracking for training initiatives.
  • Coordinating and executing on 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.
  • Assisting with analyzing HCC risk and developing plan of action to address those areas of risk, including but not limited to working closely with Legal and the Business stakeholders.
  • Responsible for supporting 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.
  • Assists with 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. 
  • 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 Sr Dir /Dir Healthcare Compliance Int’l.

PREREQUISITES:

  • Minimum of Bachelors Degree.
  • One (1) to three (3) plus years of relevant pharmaceutical/biotechnology industry experience, including tone (1) to three (3) years of Healthcare Compliance experience (or equivalent) (including anti-bribery/anti-corruption) in the life sciences / pharma industry.
  • Advanced Degree and/or CPA/CA or equivalent certification strongly preferred.

Competencies:

  • Proven track record for implementing Compliance policies, procedures, and processes.
  • Demonstrated ability to multi-task, extraordinary organized, task and goal oriented.
  • Ability to work cross-functionally and collaboratively.
  • 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.
  • Knowledge of most common office software (Microsoft Office) especially Excel and Project.

#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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About Celgene

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

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