Celgene Scientific Affairs Advisor + Final Medical Signatory - 12 month fixed term contract in Stockley Park, United Kingdom
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.
A registered medical practitioner or pharmacist who is a final medical signatory, with an excellent knowledge of the ABPI/IPHA codes of practice.
To provide a comprehensive medical information service to internal and external customers and to support improvements and maintenance of medical information systems.
Manage out of hours calls and the out of hours service provider contract.
Works closely with other Scientific Affairs Advisors to help provide scientific advisory support for claims / materials development and approval, ensuring compliance with the relevant Code’s of Practice and legislation.
Act as an experienced key member within the cross-functional disease team, working closely with Medical Affairs, Marketing, Market Access and Regulatory, maintaining high levels of Code compliance whilst supporting commercial and medical aims and activities.
This role is offered on a 12 month fixed term contract.
Role and Responsibilities
Acts as final medical signatory for the team.
Works cross-functionally and collaboratively to develop compliant solutions for various different projects and is seen as an expert on the ABPI/IPHA codes of practice
Develops a good working knowledge of Celgene Standard Operating Procedures (SOP) with the aim of being able to advise on compliance issues and certify materials (as required)
Provide scientific advisory support for claims/ materials development, ensuring medical accuracy of scientific content, and compliance with relevant Codes of Practice and legislation. Responsible for data provision and ensuring data maximises commercial potential
Input into Code of Practice defence of claims from competitor companies, healthcare professions and regulatory authorities as required
Actively involved in the development and implementation of operational plans including disease team and medical plans, and also takes the lead on specific tactical objectives and deliverables
Supporting Medical Affairs and the Marketing team to develop market leads for developing and driving the disease team plan and leveraging clinical scientific data to optimise the adoption of the promotional campaigns
Prepare and deliver brand-related presentations and training to field teams as required
Act as final medical signatory for a variety of meetings to support the disease team as required, including commercial meetings (e.g. Celgene-led meetings), congress support and medical meetings
Act as a point of escalation for medical information queries
Support and manage the third-party service provider including management of contracts, working practices and regular quality control checks to ensure compliance with relevant procedures and legislation
Formulate high quality written and telephone responses reflecting the most recently available data on Celgene products in response to enquiries received from both internal and external customers and ensure responses conform to both company guidelines and practices and the ABPI code of practice
Develop and maintain Medical Information standard responses for use in The UK and Republic of Ireland in collaboration with Global Medical Information
Further develop and maintain the internal Medical Information database
Perform weekly quality checks (QC) checks on medical information responses, liaising with US colleagues to ensure global consistency and provide reports for all safety enquiries received via Medical Information, to the drug safety team for reconciliation
Support out-of-hours emergency cover in collaboration with Medical Director / Associate Director Medical Affairs
Ensure adverse events and pregnancy reports are duly processed in line with company procedures and assist in assessment of adverse event reports originating in the UK and Ireland for completeness, consistency and reporting requirements
Attends medical congresses to staff medical affairs booths and acts as an information resource for the company’s products. Ensures the disease team are updated on relevant data acquired from medical congresses
Manage the company’s Copyright licences. Liaison with the Copyright Licensing Agency to ensure all clinical papers distributed or received are within copyright laws and our licence
Responsible for the development/maintenance of relevant SOPs, in collaboration with the Medical Director and Regulatory, Quality and Compliance team
Skills and Knowledge Requirements
Registered medical practitioner or pharmacist, registered in the UK
Essential to have past Pharmaceutical Industry experience and preferably prior experience in the provision of Medical Information service
Final medical signatory with excellent knowledge of the ABPI Code of Practice
Past experience in Haematology/Oncology therapy area desirable
Proven skills in:
Literature database searching and related computer skills
Clinical data interpretation
Medical writing skills
Customer communication skills including a good telephone manner
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