Celgene Medical Affairs Operations Associate Manager 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:
- Support of the IIT processes for centrally managed IITs:
a) Support the IIT review and approval process as needed;
b) Update regularly the IIT tracking system (IMAGE);
c) Manage the Investigator Brochure request and tracking;
d) Keep the IIT folders and documentation up-to-date;
e) Collaborate extensively with other functional teams (e.g, Drug Supply, Contracting, Global Drug
Safety & Risk Management, Clinical Development, Project Leadership) to ensure efficient processes
are in place and functioning;
f) Help organizing IIT meetings as needed.
- IIT Budget Management for centrally managed IITs:
a) Support the review and negotiation of IIT budget;
b) Ensure all budget and budget changes are appropriately approved, documented, reported and tracked;
c) In collaboration with Finance Dept, ensure that systems for IIT budget tracking are compliant and up to
d) Track, review and approve invoices.
- Cooperative Group studies:
a) Establish strong collaborative relationships with Cooperative groups with respect to the study
management of IIT Studies;
b) Work in close collaboration with Study Manager of Cooperative groups to ensure projects are executed
in a timely manner and to high quality;
c) Work in close collaboration with Celgene Contracts team, Legal team and Cooperative groups to
ensure contracts are executed in timely manner;
d) Act as primary contact for Drug Supply process including provision of forecasting and drug request;
e) Liaise closely with other functions such as Regulatory, Data Management, Global Drug Safety & Risk
Management, Statistics, Project Leadership;
f) Track progress of study & provide monthly updates on status to all internal stakeholders.
- Affiliate support
a) Provide support, guidance and information to Affiliate IIT personal as required;
b) Act as interface between affiliate and other support services to rapidly resolve any issues arising in the
IIT implementation for studies within scope of responsibility;
c) On an as required basis, organize meetings with Affiliates and all relevant people in order to provide,
training, discussion forums and sharing of best practice.
• Experience in managing GCP clinical studies within Europe preferably in multinational studies.
• Sound knowledge of GCP and ICH guidelines.
• Good understanding of financial systems and of contacting process (desirable, but not required).
• Excellent communication and interpersonal skills with ability to communicate and coordinate across
• Excellent organizational skills.
• Proactive with an ability to multitask and prioritize.
• Knowledge of and experience in oncology/haematology
• Ability to speak French would be an advantage (but not required)
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