Celgene Associate Manager Healthcare Compliance, International in Boudry, Switzerland
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 is responsible for coordinating, tracking, and executing International Healthcare Compliance (“HCC”) projects in support of the Healthcare Compliance Program. Including communication plans, training, process design, governance, and maintenance.
Under the direction of the Director Healthcare Compliance, International, the position is responsible to operationalize Healthcare Compliance (“HCC”) policies and initiatives.
This position requires close collaboration and coordination with other regional HCC teams, Legal, IT, Commercial Operations, 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.
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 Healthcare Compliance Program initiatives including but not limited to enhancing processes for the management of Fees for Services, or Grants, Donations, Sponsorship Funding.
Driving projects to ensure efficient use of resources, and create synergies across global geographies for HCC 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 development, implementation and operationalization of Policies and Procedures, including but not limited to assistance with procedural documentation and an understanding of the intent of 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.
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 Dir Healthcare Compliance Int’l.
Advanced degree or certification (CPA, CA, MBA) preferred in combination with a strong background and experience in a life-sciences industry company in a Healthcare Compliance role.
Additional certifications (e.g., HCC certification, CFE, etc.) will be considered an advantage.
Three (3) to five (5) plus years of relevant pharmaceutical/biotechnology industry experience, including two (2) to five (5) years of Healthcare Compliance experience (or equivalent) (including anti-bribery/anti-corruption) in the life sciences / pharma industry.
Knowledge of US and ex-US geography laws, regulations and industry code requirements.
Two (2) to (5) plus years of project management experience.
Strong proficiency in Microsoft Excel, PowerPoint, Word and Project.
Strong proficiency in Microsoft Excel, PowerPoint, Word and Project.
Strong proficiency in SharePoint and data visualization tools such as Tableau.
Proven track record for implementing Healthcare Compliance policies, procedures, and processes.
Demonstrated ability to multi-task, extraordinarily 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.
Strong proficiency in most common office software (Microsoft Office) especially Excel and Project.
Direct and Indirect Reports: No
Travel: Position may require about 30% travel
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.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.