Celgene Manager, U.S. REMS Strategy and Policy in Summit, New Jersey

Description

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.

POSITION

Manager, U.S. REMS Strategy and Policy

SUPERVISOR

Sr. Director, U.S. REMS

DEPARTMENT

U.S. REMS

LOCATION

Summit, NJ

PREREQUISITES

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

Other

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

Minimum Qualifications:

  • 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

Desired Competencies:

  • 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

#LI-POST

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.