Other Locations:Sweden- Kista
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 HCC manager is responsible for the healthcare compliance role in the Nordics (Denmark, Finland, Iceland, Norway and Sweden). The manager will act as compliance officer, and defend and maintain HCC standards according to current legislation/codes in the Nordic region & global Celgene policies & procedures.
The HCC manager will provide guidance to multidisciplinary teams (e.g. disease teams) to ensure that all HCC activities developed and performed, are in compliance with applicable regulatory demands (legislations and guidelines).
Responsibilities include, but are not limited to, the following:
Health Care Compliance:
- Plan, design, operationalise and maintain the local health care compliance HCC program (set of SOPs, trainings, communications, controls, reports) to ensure compliance with the applicable HCC requirements (e.g. local code, applicable rules and legislations, corporate policies requirements etc.)
- Review local HCC activities in accordance with corporate global policies, local SOPs and local code
- Participate in HCC audit preparation: prepare documentation requests, set-up meetings with the applicable functions/team members
- Lead / support HCC action plans, preventive actions corrective actions (CAPAs) as per HCC audit results
- Support the sr. mgmt. & general manager to identify the need for specific local processes, procedures and tools to accomplish HCC initiatives and goals and act in accordance to mitigate the relevant risks (tools implementation, SOPs, training etc.)
- Evaluate the need and develop/revise healthcare compliance controlled documents, templates and training, if necessary.
- Act as key contact point for healthcare compliance within the affiliate, with the HCC EMEA director, the general manager and the global compliance group (GCG) for activities in the scope of HCC
- Review, translate, (if applicable), provide comments and implement HCC SOPs, presentations, communications and trainings.
- Represent local HCC on global, international or regional cross-functions teams
- Provide advice, guidance, and support to the affiliates staff on the interpretation and implementation of the local trade association code, Celgene corporate global policies and other applicable rules and regulations (e.g. EFPIA).
- Assist in the implementation of the corporate compliance program (e.g. SOPs template in the country)
- Provide an overview of the local compliance status to the general manager, EMEA HCC director and to the global compliance group (as appropriate).
- Participates in the approval process of all oral and written promotional or non-promotional items for external audiences according to the regulations and legislations in the Nordics.
- Represents Celgene’s interest in national and international HCC forums and influence groups.
- Monitors national and international applicable legislation.
- University degree in a relevant scientific/legal discipline.
- Minimum of 5 years pharmaceutical industry experience in the relevant areas
- Documented experience and knowledge in HCC.
- Ability to build national networks and relationships.
- Anticipate trends/changes in regulatory environment.
- Advanced understanding of structure & workings of regulatory bodies in countries assigned.
- Must be able to innovate, analyse and solve problems with minimal supervision and attention to detail.
- Inter-dependent partnering skills, team-oriented and ability to influence outcomes.
- Excellent communication skills (verbal and written) in one Nordic language and English.
- Domestic and International travel may be necessary.
- Negotiation, collaboration, persuasion, communication and relationship building skills.
- Highest level of integrity.
- Discrete and able to protect confidential information.
- Role model for ethical behavior.
- Investigative and problem’ solving skills.
- Ability to work in a highly matrixed organization.
- Awareness of cultural diversity.
- Personal and professional maturity
- Ability to prioritise
- Documentation management
- Presentation skills
- Ability to work independently