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Mgr, Health Care Compliance

Req #: 1700809
Location: Munich, BY DE
Job Category: Regulatory Affairs
Work Location: Joseph-Wild-Strasse 20 MÜNICH 81829
Organization: Celgene GmbH
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:Germany- Munich

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 Healthcare Compliance Manager / Senior Manager is responsible for the local operationalization, implementation and monitoring of all relevant Compliance regulations. Under supervision of the HCC Lead he oversees the local Healthcare Compliance Program. If the incumbent is not the Healthcare Compliance officer himself, all responsibilities are handled in close collaboration and exchange with the Health Care Compliance officer. This position requires close collaboration with all local functions, regional and global HCC functions.

Specific responsibilities include but are not limited to the following:

  • Support to plan, design, operationalize, implement and monitor the local cross‐functional Healthcare Compliance (HCC) program to ensure local compliance with applicable internal and external rules and regulations (e.g., local Code, Corporate Policies, local specific legislation);
  • Support and advise HCC Board in all HCC relevant questions; report on a regular basis to the local HCC board on compliance matters assisting the General Manager and the HCC Board to establish appropriate methods to reduce the company’s healthcare compliance risk;
  • Provide advice, guidance, and support to the affiliate staff on the interpretation and implementation of the local trade association code, Celgene Corporate Policies and other applicable rules and regulations (e.g. EFPIA) assisting in creating a culture of compliance. This includes promote an open communication and dialogues where affiliate staff feel comfortable speaking up;
  • Manages day‐to‐day operation of an effective HCC system for the organization;
  • Institutes and maintains an effective compliance communication for the organization, including promoting use of the Compliance Hotline;
  • Support with the periodically review and update of the local HCC program, as appropriate, to respond to changes in the company’s needs and applicable local and global requirements, identified weakness in the program, or identified systemic patterns of noncompliance;
  • Develop, coordinate, and participate in multifaceted educational and training program that focuses on the elements of the compliance program, and seeking to ensure that all affected employees and management are aware of, understand and comply with pertinent standards;
  • To work with the HCC Lead to review and, where appropriate, act in response to reports of noncompliance, lead, coordinate and conduct internal investigations as well as ongoing risk assessment, evaluation, anticipation, minimization and avoidance. This includes establishing and implementing remedial activities for specific local HCC audit findings or other potential risk areas and interacting and following through with applicable departments and functional heads for corrective actions, preventive actions and implementation;
  • Remain informed of developments in applicable HCC and general compliance rules, laws and enforcement trends (anticipate risks, react/response efficiently and flexible to regulatory changes and changes in business environment);
  • Works with the Human Resources Department and others as appropriate to develop an effective compliance training program, including appropriate introductory training for new employees as well as ongoing training for all employees and managers;
  • Maintain awareness of current legislation and corporate policies to ensure these are reflected in local procedures;
  • Act as contact for global compliance for activities in the scope of HCC: local self‐inspections and review / translation of Corporate Policies, Regional Template SOPS, presentations, communications and trainings;
  • Coordinates HCC Due Diligence of vendor organizations;
  • Acts as local designated compliance responsible (LDCR); reviews and approves local preparation of standard contracts;
  • Represents local HCC on global, international or regional cross functions teams (including EMEA HCC Forum);
  • Participates in HCC audit preparations: prepare documentation requests, set‐up meetings with applicable functions/team members;
  • Leads/supports HCC action plans, preventive/corrective actions (CAPAs) as per HCC audit results.

Skills/Knowledge Required:

  • Strong identification with Celgene’s values;
  • See prerequisites. Candidates will be considered only if they have extensive HCC experience. Additional certifications (e.g., HCC certification, certified compliance officer education etc.) will be considered plusses;
  • Fluency in English is required;
  • Minimum of 3+/5+ year experience in HCC in the life sciences industry / Pharma industry;
  • Life sciences/pharma audit background will be considered plusses;
  • Experience with local HCC regulations and industry codes would be also considered a plus;
  • Project management skills;
  • Demonstrate character, with high level of integrity and honesty;
  • Achieve results, driving execution/speed and efficiency;
  • Inspire and motivate, promoting open communication and foster teamwork;
  • Ability to work in a geographically dispersed and multi‐cultural team;
  • Lead change, driving innovation and applying global mindset;
  • Demonstrated ability to build alignment, influence, execute and connect cross‐functional and at all levels of the organization;
  • Strong interpersonal and organizational skills with high emotional intelligence. Excellent listener; inclusive, seeks broad input and feedback; frequent and effective feedback/follow‐up;
  • Effective communication at all times. Experience in delivering complex messages, in a matrix organization, to a diverse audience with a track record of effective and influential presentations;
  • Proven team player with ability to navigate cross functionally;
  • Ability to build strong credibility at local level, to effectively interact, providing direction, challenge and support whenever relevant;
  • Act as a role model for ethical behavior.

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