Outsourcing Manager

Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods techniques and evaluation criteria for obtaining results. Knowledge of FDA regulatory requirements. This position will require minimal supervision. May determine methods and procedures on new assignments and will provide guidance to contract analysts and operations associates/assistants.This individual should have demonstrated experience and ability in clinical trial contract budgeting and negotiation. In addition to the capabilities and duties above this individual will act as an outsourcing and contracts manager for all clinical trials outsourced contracts. He/she will be responsible for assisting in the coordination of clinical trials contracts from the identification of need through execution analysis and reporting. This individual will assist in preparation of reports and metrics relating to the contract process. He/she will assist in screening vendors and interacting with vendors over contract-related issues coordinating vendors and other contractors and performing other specialized functions including assisting with the development implementation and use of a strategic trial insourcing/outsourcing analysis tool. This individual will coordinate with other Resource Performance Management and Operations personnel and process train the Medical Organization department. He/she will aide in the preparation and review of process instructions/SOPs as well as RFP and contract templates. This individual will perform other duties as assigned.Minimal qualifications include a Bachelor equivalent degree in Biology Microbiology or related field. Generally requires a minimum of 5-10 years of experience in medical research in industry or equivalent experience including at least 5 years in clinical trials management and contract negotiation and finalization. Good interpersonal communication and organizational skills; computer skills including word processing; and ability to travel as needed.Description of Position Duties and Responsibilities:Primary responsibilities will include working within MedImmune Inc.’s Medical Organization Resource Performance Management group as an outsourcing manager responsible for the oversight of the negotiation and finalization of Contract Addenda Contract Modifications and Task Specification Addenda for various MedImmune Inc. product lines with Contract Research Organizations and other key vendors.Duties include supervising and being the primary contact for liaising with multiple MedImmune Inc. teams and vendors to assess needs quantify and/or review specifications and determine pricing to reach agreement; review and analysis of existing contractual agreements and budgets for negotiation of large scope changes to programs; and solution facilitation for a non-traditional situation involving contingent workers at MedImmune with expiring contracts to keep these valuable resources working on teams and projects among other duties. CLICK HERE TO APPLY MedImmune, Inc. 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. Job Title: Outsourcing Manager Location:  Gaithersburg, MD 20878 Status:  Full Time, Employee Job Category:  Sales/Retail/Business Development