Celgene Coordinator, Medical Affairs Operations & Compliance, 2 years fixed term contract 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.
Involvement in operational activities to support the Study Team/Management with all study related activities in all phases of the conduct of one or more clinical studies
Organize and actively contribute to study meetings. Generate, finalize and distribute study team agendas and meeting minutes and/or review and file minutes generated by vendors
Develop and use performance metrics and quality indicators to assist the Study Team/Management in driving study execution
Assist the Team in the preparation of study specific tools (including communication tools such as newsletters, flyers etc.)
Responsible for set-up and maintenance of study specific trackers to ensure continuous oversight of the study progress
Manage collection, review and tracking of study documents as necessary
Lead / Participate in monitoring visit report review process
Update clinical trial databases
Ensure that clinical studies are conducted in accordance with the protocol and internal Standard Operating Procedures (SOPs)
Responsible for the management of study specific TMF (setup, maintain, quality review, archival) including, document tracking and archiving throughout the duration of the study in accordance with SOPs.
Proactive identification of potential risks and development/implementation of actions
Develop and maintain collaborative relationships with internal and external partners/stakeholders
Collaborate with vendors and other internal stakeholders regarding study specific issues and follow through to resolution
Participate in vendor specification development and management/oversight
Assist with Investigator meeting coordination and planning
Contribute to development / coordination of study training
Assist with maintenance of study budget tracking tools and reconcile invoices
Track progress of study and provide monthly updates on status to all internal stakeholders.
Quality Management Systems (Electronic Documentation Repositories and Databases):
Generation and maintenance of files and related databases proactively, and in accordance with the procedures and policies in place
Management of the access to the systems for the relevant personnel
Involvement in the development, maintenance or enhancements of the systems
Assist with the creation of training and supporting materials, and with the training of the relevant personnel
Developing and performing quality controls on the electronic databases and documentation repositories under the direction of the MA Management
Generating and distributing reports
Compliance Management and Systems:
Upload job bags in Zinc and work with team ensure document approval within timelines
Gather and file required documents, request and process contracts in ORACLE for Advisory Boards, Investigator Meetings and other Medical Affairs Programs.
Maintain Compliance folder up to date for all assigned projects
Assist with the generation and distribution of tools and guidelines to support the Medical Affairs teams within the EMEA region and International Medical Affairs personal as needed.
Support the maintenance and update of the standard operating processes (SOPs) and WPs, under the direction of the MA Management, and promote adherence to the current processes.
Participate in the initiatives and projects linked to the coordination and oversight of the Celgene Study Programs as needed.
Contribute to continuous improvement on the responsibilities above and promote high quality standards and audit readiness.
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