Celgene Director, US Healthcare Compliance, Hematology/Oncology 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, US Healthcare Compliance, Hematology/Oncology will work closely with the Senior Director, US HCC Hem/Onc in supporting the mandate of the US Healthcare Compliance Program by providing guidance to the Commercial, Medical and Clinical teams within the US Hem/Onc Franchise.
Under the direction of the Executive Director US HCC, the position is responsible to operationalize Corporate and Healthcare policies and initiatives.
This position requires close collaboration and coordination with business stakeholders, other members of the US and Global Healthcare Compliance 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 the Hem/Onc Business.
This position will be based in Summit, NJ and will require some travel in support of compliance training initiatives, monitoring activities, and other requirements as needed.
Identifying potential areas of healthcare compliance risk and developing plans of action to address those areas of risk, working closely with Legal as needed.
Working with the Senior Director, US HCC Hem/Onc on the implementation and operationalization of Celgene Policies, Procedures and specific SOPs for the US Hem/Onc Franchise, including but not limited to ensuring effective training and documentation. Assisting with SOP and policy drafting, as needed.
Taking a leading role in establishing remedial activities for monitoring and/or audit findings and partnering with applicable department and functional heads to ensure the appropriate implementation of those corrective actions.
Maintaining a good understanding of developments in applicable healthcare compliance legislation, initiatives and enforcement trends for the US and actively sharing this information across relevant functions.
Supporting HCC investigations as appropriate on compliance matters referred by the Compliance Investigations Committee.
Ensuring regular HCC updates and activity monitoring to the US HCC and monitoring teams.
Managing the compliance training requirements for the US Hem/Onc business as specified by the risk assessment and Business needs, and providing regular updates to senior management on the levels of training compliance within the US Hem/Onc Franchise.
Performing other compliance-related activities as directed by the Executive Director, US HCC.
A minimum of a bachelor’s degree and a strong background and experience in a life- sciences industry company.
Additional certifications (e.g., HCC certification, CCEP, CFE, etc.) will be considered an advantage.
Ten (10) plus years of relevant pharmaceutical/biotechnology industry experience, including three (3) years of Healthcare Compliance experience (or equivalent)
Equivalent experience includes experience in Quality, Regulatory, Operations, Medical or other similar roles.
Subject Matter Expert in US laws, regulations and PhRMA code requirements.
Excellent interpersonal, collaborative and organizational skills.
Works independently, yet effectively in a team environment.
Excellent written & oral communication skills.
Demonstrated ability to work cross-functionally and collaboratively.
Demonstrated ability to guide implementation of HCC policies and SOPs.
Experience in risk assessment and mitigation.
Ability to focus attention to details and to create and execute implementation plans.
Excellent investigational and problem-solving skills.
Knowledge of most common office software (Microsoft Office)
Direct and Indirect Reports: None
Travel: Position may require about 10-15% domestic 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.