Celgene Manager, U.S. REMS Strategy and Policy 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.
Manager, U.S. REMS Strategy and Policy
Sr. Director, U.S. REMS
BS/BA required (degrees in progress considered). 5-7 years Pharmaceutical experience in REMS Operations, Medical Communications/Medical Affairs, Regulatory, or Safety/Pharmacovigilance. REMS experience preferred.
The Manager of REMS Strategy and Policy reports directly to the Sr. Director of REMS Strategy and Policy and will be responsible for overall coordination and process management related to FDA submission activities and REMS (Risk Evaluation Mitigation Strategies) Assessments Reports for the Celgene REMS programs. This individual contributor will serve as a liaison within the internal U.S. REMS department as well as between the U.S. REMS department and the members of the REMS Committee Review members. He/she will direct external vendors to support the REMS Modification process and also support REMS Strategy and Policy projects such as internal and external U.S. REMS communications, execution of publication plans, and data analysis.
Responsibilities will include, but are not limited to the following:
REMS Regulatory Submissions Coordination and Process Management
Manage the development of REMS regulatory submission documentation (including REMS modifications, sNDA REMS submissions, communications, etc.) for FDA submission
Organize and appropriately document (within internal databases) the formal internal review process for REMS regulatory submissions to ensure the integrity and compliance of REMS regulatory submissions are maintained
Liaise with internal multidisciplinary REMS stakeholders (Regulatory Affairs, Regulatory Operations, Safety, U.S. REMS, and Legal) to keep track of and ensure capture of updates within REMS submissions
Manages the creation of supplementary materials to support REMS regulatory submissions
Lead live meetings (REMS Copy Review resolution meetings, status meetings, etc.)
Direct internal and external stakeholders and vendors to create and supply the necessary components to complete the REMS submission at hand (REMS materials, screenshots, etc.)
Ensure the utmost quality of REMS submission content through in-depth review of submitted documents, attention to detail, and verification of facts/changes to materials
Utilize project management skills to ensure high quality deliverables are provided in a timely manner
FDA REMS Deliverables
Supports the narrative development process and data analysis of high quality FDA deliverables such as REMS Assessment Reports, FDA response inquiries, ad hoc survey results, etc.
Ensure the coordination and execution of timely and efficient internal review and approvals of FDA REMS deliverables
Collaborate with other internal departments to obtain information and data as needed to support the creation and development of FDA REMS deliverables
Responsible for the quality of output documents and ensures content meets appropriate editorial standards (style, formatting, document requirements, etc.)
REMS Communication Documents
Maintain status and contribute to REMS communication initiatives such as publication plans, external presentations, and problem statement documents
Maintain REMS literature virtual library
Serve as REMS Strategy and Policy internal database administrator
External Risk Management/REMS Pharmaceutical and Regulatory Environment Monitoring Research best practices and changing trends of REMS operations and REMS program improvements Create and maintain REMS strategy informational tools and database Data analysis and management with Reporting
Obtain, analyze, and summarize REMS data to provide data-driven conclusions and make appropriate recommendations/solutions
Provide monthly reports on REMS Strategy and Policy activities
Represent REMS Strategy and Policy on cross functional projects within U.S. REMS in support of other U.S. REMS departments (Customer Care, Quality Operations, REMS Technology, and REMS Advisor/Training)
Ensure REMS Strategy and Policy Standard Operating Procedures and Work Practices are kept up-to-date and maintained
Support internal audit and regulatory inspection activity as needed
Assist with ad hoc projects and additional tasks as assigned
BS/BA required, advanced degree in healthcare science, public health, or applicable fields, a plus
5 years previous experience in Pharmaceutical Industry (REMS Operations, Medical Communications, Regulatory, or Safety/Pharmacovigilance or relevant disciplines)
Have advanced skills in MS Word, Excel, and PowerPoint.
Medical/REMS document preparation experience, a highly desired
Risk Evaluation Mitigation Strategies (REMS) knowledge and experience, highly desired
Ability to independently manage multiple projects with accountability and excellent work ethic
Proven skills in collaboration with cross-functional teams and in a team environment
Excellent and effective verbal and written communication skills with the ability to interface with REMS Leadership team, interdisciplinary project teams, and external vendors
Acute attention to detail
Adaptive, resilient, and nimble character, yet firm and sturdy in conviction and ethics
Highly strategic and proactively recognizes problems and foresees opportunities with a tendency to act with a solutions-driven attitude
Gradual ability to analyze REMS operational data and in turn recommend strategies, and prepare written reports and presentation
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.