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My company shares my
passion for helping to improve human health around the world."
"This is My MedImmune."
Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc.
Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities…that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world.
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Title: Manager, Medical Information
Location: MD, Gaithersburg - Corporate Headquarters
Req: 02066
Position Summary:
The purpose of the role is to assist the Associate Director, Medical Information, with the leadership and management of the Medical Information Specialists functions. This includes analysis and reporting of Medical Information metrics and the functional liaison with Medical and Scientific Affairs (MSL’s and MSD’s), Marketing and other Departments in MedImmune.
Overall responsibility is to assist the Associate Director, Medical Information with ensuring responses to medical information requests are in compliance with all related FDA regulations regarding communication and dissemination of medical information adhering to all regulations, guidance, MedImmune corporate policies and procedures. Collaborate with Clinical and Marketing Departments for development and drive of the product information and key messages externally and internally throughout the company.
Assist the Associate Director, Medical Information, in the management of the roles and responsibilities of the Drug/Medical information Department (DI/MI) that apply to products to ensure compliance of regulatory requirements and Standard Operating Procedures (SOPs) pertaining to medical information, documentation and dissemination of information. Provide support to regulatory affairs, clinical R&D and other product business units in the context of DI/MI services.
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Major Duties and Responsibilities:
Assisting the Associate Director of Medical Information in all of the following activities as they apply to assigned products:
1. Responsible with assigned product(s) for the clinical and medical content, review and approval of new and revised medical information Standard Response Letters (SRLs), annual review of existing SRL’s, which represent the response of MedImmune Inc. to the medical and patient community regarding medical information Inquiries.
2. Provide DI expertise in assigned areas to the Medical Information Specialist group.
3. Assist with staff development through industry training programs, personal and career development, Pharmacy students, Medical Information Resident, clinical product knowledge expertise and fostering a standard of excellence throughout DI/MI.
4. Represent Medical Information Department at various (internal) management and Business Unit functions/meetings.
5. Generate written reports (internal and external departmental reports) for trend analysis and tracking of medical information inquiries as requested to assist the Senior Management team.
6. Conduct quality assurance audits of medical information responses.
7. Monitor the activities of and provide support to the Medical Information Specialists regarding product knowledge management, standard responses and the workflow of these documents.
8. Regularly monitor the current medical literature to identify publications that may impact assigned product(s) and disseminate or notify others in business unit that are affected.
9. Contribute to the writing of MAD-B, monographs, or other focused medical information projects.
10. Assist with regularly monitoring, evaluating, and reporting on the adverse event and product complaint reporting notification activities performed by Medical Information Specialists. |
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| MedImmune, LLC. is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law. |
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To search for an open position, please go to http://medimmune.appone.com/ |
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