Manager, Medical Information

Company OverviewImClone Systems is dedicated to developing and commercializing novel therapeutic products in the field of oncology. Our efforts have resulted in a broad spectrum of innovative product candidates with potential application in multiple tumor types. As a member of the oncology community, we are committed to providing treatments to meet the unmet needs of cancer patients. To fulfill this commitment, ImClone Systems fosters integration of the principles of teamwork and scientific integrity into all facets of the Company's activities. We believe that these values will benefit patients, physicians, and our employees while creating value for our shareholders. HistoryThe Company was founded in 1984 and in 1986, opened its laboratories at 180 Varick Street in New York City. In its early years, the Company focused on immunology-based diagnostics and infectious disease vaccines. This focus resulted in two FDA approved diagnostics and several vaccine research programs, all of which have been licensed to pharmaceutical companies. During the early nineties, the Company's focus shifted from diagnostics and infectious disease to the development of a pipeline of innovative, biologic compounds in the area of oncology. From this pipeline, three investigational monoclonal antibodies are being evaluated in various stages of clinical development. OperationsImClone Systems operates in two locations - its corporate and scientific headquarters at 180 Varick Street in New York City, which houses the Company's research and executive offices, and its campus in Branchburg, New Jersey. The Branchburg facility is home to the manufacturing, product development, finance, clinical, regulatory and quality assurance and commercial operations departments. Provides a leadership role within the Medical Information department by assisting in the planning, developing, reviewing, and coordination of medical information activities. Offers guidance and support to junior staff as necessary. Interacts with other departments to provide the clinical/medical data/information necessary for the timely completion of their work.1. Writes and edits Medical Information Letters in response to written physician inquiries on ImClone Systems marketed products.2. Member of the Copy Review Committee that develops and/or reviews on-label product material, sales force field direction, Medical Information Responses, Product Objection Handler Responses, and product slide decks.3. Responsible for editing and maintaining departmental Standard Operating Procedures.4. Responsible for the timely completion/coordination of all components of a project or program.5. Supervises Medical Information Service Associate staff..6. Interacts with departmental staff, contract vendors, corporate partners, or outside organizations affiliated with the Company, to provide product information for physicians or investigators.7. Responsible for the routine review of published literature regarding the Company's products and the collection and archiving of the publications.8. Maintains technical proficiency and professional skills of self through literature review and attendance at conferences, seminars, courses, or clinics.9. Follows departmental policies, procedures, and SOPs. 1. Four to six years of progressively increasing experience, either in medical affairs, medical information, clinical affairs, medical writing, or regulatory affairs, within the pharmaceutical industry.2. Thorough knowledge of Food and Drug Administrations regulations, applicable industry guidelines and industry recommendations for the conduct of clinical investigations. 3. Supervisory experience of personnel preferred.4. Ability to manage projects and/or programs.5. Ability to write product summaries and reports, and SOPs in a clear, focused, and concise manner.6. Ability to achieve departmental and Company goals in a timely manner.7. A minimum of a Bachelor's degree in a discipline relevant to the pharmaceutical industry, such as Nursing, Life Sciences, Pharmacy or Medicine. RESPOND HERE! Respond immediately by accessing the following dedicated online response form which will allow you to cut and paste your resume. This form will go directly and immediately to the hiring authority for this position. Access the online response form at: http://sh.webhire.com/servlet/resp/rf?jobid=2211200&boardid=749