Medical Affairs Operations Manager

Req #: 1803785
Location:Boudry, NeuchatelCH
Job Category:Medical
Work Location: Route de Perreux 1 BOUDRY 2017
Organization: Celgene R&D Sarl
Schedule:40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:Switzerland- Boudry

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.

Responsibilities may include, but are not limited to, the following:

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.

Local Non-Interventional Studies Approval Process

• Support the approval process as needed in accordance with SOPs.

​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.

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.

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

Desirable

• Knowledge of and experience in oncology/hematology

• Good understanding of financial systems and contracting process

• Experience in line management

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