Celgene Medical Affairs Operations Specialist in Braine, Belgium
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.
The Medical Affairs Operations Specialist (MAOS) will be responsible for the handling of local requests for Medical Information/Scientific Communications and related activities for both internal and external customers.
In addition, he/she will be responsible for the operational aspects of the management of local Investigator Sponsored Trials (IIT’s) in close collaboration with the Regional Medical Liaisons (RMLs) and Medical Affairs Managers (MAM’s) / Medical Advisors.
He/she will contribute to Celgene Belgium inspection readiness: execute all Medical Affairs Operations activities according to global and local procedures.
The MAOS is a member of the Medical Department team which encompasses Medical Affairs, Clinical Operations and Drug Safety.
Role and responsibilities
Handle medical information requests from external and internal customers within the Global Medical Information database and according to Celgene global and local standards
Manage off-label product requests according to local regulation and Celgene standards ensuring individual HCP education on safe use of the product
Ensure appropriate tracking and coding of all product requests
Pro-actively contribute to enhance Med Info tracking and reporting systems
Ensures Med Info signal detection, distribution and stakeholder discussion of FAQ’s on relevant topics, disease areas and/or Celgene products. Leverage internal and external customer insights
Closely collaborate with local drug safety department to ensure constant reconciliation of requests according to Celgene’s adverse event reporting standards
Work closely and participate actively in Celgene's European and Global Medical Information Network
Support development of Affiliate Medical Education materials, in accordance with local and European medical disease strategy
Ensure highest scientific standards and alignment with national, EU and global strategies, guidelines and legal regulations
Support Medical Affairs disease leads with local publication planning: responsible for following up on publication plans and implementation
Support local Medical Affairs disease leads in the development of medical and scientific presentations in alignment with and disease strategic plans; for example, for Advisory boards, trainings etc.
Ensure scientific materials are developed and reviewed according to Celgene SOPs
Responsible to consolidate local quality management system on scientific communication
The MAOS is the internal point of contact in the affiliate and towards Medical Affairs Operations in HQ for all operational aspects off IIT management always in close collaboration with the RMLs who ensure communication with the investigator and the MAM’s/MA’s who focus on the internal communication with the Medical Affairs Disease Leads (MADL’s) in Head Quarters (HQ),
Coordinate all relevant internal stakeholders (i.e. RML, Medical director, contract specialists, drug safety etc) along the process of IIT management
Is responsible that all steps in the IIT process are followed according to Celgene standard procedures within timelines and budget
This encompasses, but is not limited to: collect and internally submit proposals for review and approval, protocol development & contracting, drug supply and forecasting, IB distribution, milestone payment tracking etc
Responsible to establish a local IIT reporting and analysis system, tool
The MAOS is responsible to produce IIT status progress metrics and outputs
Scientific degree in a relevant scientific discipline, ideally at PhD level.
Experience in Medical Information and the planning & execution of investigator initiated studies would be beneficial but is not a pre-requisite.
Medical Affairs or Clinical Operations experience would be beneficial but is not a pre-requisite.
Demonstrates a track record of positive customer interactions and relationships.
Excellent organizational, communication and time management skills.
Good project management skills.
Excellent team player.
Strong identification with Celgene’s values.
Fluent (written and verbal) in English plus fluent in one or both of French / Dutch. If fluent in either French or Dutch then you should have a good working knowledge of the other language.
Computer literate: good knowledge at user level of Microsoft Office, Excel and PowerPoint.
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