Job Detail

Req #: 1803785


Location: Boudry, Neuchatel, Switzerland


Job Category: Medical


Work Location: Route de Perreux 1 2017


Organization: Medical Affairs


Employee Status: Full-time


Job Type: Regular

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.

Skills/Knowledge Required

• • 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

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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.