Celgene Senior Manager Medical Affairs - Non-Interventional Studies 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.
Responsibilities may include, but are not limited to, the following:
1) Quality Systems
Develop, implement and maintain Standard Operating Procedures (SOPs) to promote high quality, efficient, and compliant systems for management of Celgene-Sponsored Post-Authorization Non-Interventional Studies (NIS), including Post-Authorization Safety Studies, PASS, and Post-Authorization Effectiveness Studies, PAES.
Lead Medical Affairs initiatives for ongoing process improvements.
Collaborate extensively with other functions (e.g., Drug Safety, Data Management and Statistics) to ensure efficient processes are in place and functioning optimally.
Lead Medical Affairs input to and review of safety reports, such as, PSURs and NDA reports.
2) Local Non-Interventional Studies Approval Process
- Support the approval process as needed in accordance with SOPs.
3) Affiliate Support
Provide support and guidance to Affiliates as required.
Act as interface between Affiliates and other functions to rapidly resolve any issues arising in the implementation and maintenance of studies within scope of responsibility.
Lead the organization of regular meetings with Affiliates and all relevant functions to provide training, discussion forums, and sharing of best practices for the Celgene Sponsored Studies managed within Medical Affairs.
Partner with Affiliates on projects to evolve the quality and compliance of local Non-Interventional Studies.
4) Line management
- Manage the Clinical Trial Associates working on Celgene Sponsored Post-Authorization studies conducted by Medical Affairs Operations Worldwide Markets.
5) Celgene Sponsored Post-Authorization Studies
- Act as Study Manager for Post-Authorization Non-Interventional Studies (which may be a PASS, or a PAES), or Interventional Celgene Sponsored Studies as needed.
6) External Benchmarking
- Generate and maintain a good understanding of industry standards for Medical Affairs operational practices and keep abreast of changes and developments which could impact this function.
• Experience in managing multinational clinical studies
• Experience in developing Standard Operating Procedures, and assessing for required updates according to company needs and changes in legislation
• Sound knowledge of GCP and ICH guidelines
• Excellent communication and interpersonal skills with ability to communicate and coordinate across different functions
• Excellent organization skills
• Proactive and with an ability to prioritize tasks effectively
• Strong identification with Celgene’s values
• Knowledge of and experience in oncology/hematology
• Good understanding of financial systems and contracting process
• Experience in line management
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