Celgene Senior Manager, Regulatory Affairs Advertising & Promotion in Summit, New Jersey
Summary/Scope: -Responsibilities will include, but are not limited to, the following: -
Supports interactions with the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) for assigned product(s). -
With oversight from Director level or above, develop regulatory strategies and provide guidance to other departments. -
Manage timelines and resources to achieve stated goals. -
Foster and facilitate teamwork between regulatory, legal, medical and commercial colleagues participating the Promotional Review (PACT) process. -
Assess regulatory risk and develop mitigation strategies with oversight. -
Provide regulatory advice and support to commercial teams and (PACT), with oversight. -
Develop departmental guidance and procedures. -
Manage regulatory aspects of the copy review / approval process for product promotional materials for assigned products, indications, or audiences.
Ensure compliance of promotional materials with the governing FDA regulations, and ensure submission of promotional materials to OPDP in a timely fashion. -
Design and conduct departmental training -
Monitor and interpret promotional labeling regulations and guidelines for the successful and compliant commercial marketing of Celgene’s pharmaceutical products.
Pro-actively monitor the latest regulations, guidance, and actions from the FDA and competitors that may influence the landscape.
Key Requirements/Knowledge: -
Bachelors degree (BA or BS). Scientific discipline preferred. -
3-7 years of pharmaceutical industry experience, including 2-4 years in regulatory affairs.
Knowledge of FDA advertising and promotional regulations and guidance is necessary. -
Must be able to innovate, analyze, and solve problems with minimal supervisory input. -
Excellent communications, listening, and negotiation skills are necessary. -
Leadership skills required. - Excellent organizational and time management skills needed to manage multiple ongoing projects simultaneously. -
Must be an innovator of new ideas and best practices -
Must recognize potential problems - Must have outstanding attention to detail. -
Domestic travel may be necessary.
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.
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