JOB REQUIREMENTS: 1 Serves as the Medical Operations first point of contact for assigned centers. 2 Assists with the review / preparation of Center Physician approval letters. Reviews all approval materials for completeness, interfaces with center personnel when necessary, drafts approval letter, obtains signature of Divisional Medical Director US and maintains file of materials/letters for each center. 3 Administers donor adverse action report review process including tracking/trending. Generates and distributes reports to internal customers. Works with Business Technology (BT) to create reports to support center tracking and trending of donor adverse events. Creates reports to answer specific tracking questions. Monitors related FDA and PPTA reporting. 4 Prepares lab result letters for donor’s physicians or other healthcare providers. Receives lab results letter request materials, reviews materials for completeness, interfaces with center personnel when necessary, adapts standardized letter to address donor lab results, forwards letter to appropriate requesting individual/agency, maintains copy of letter / materials in center file, and updates / maintains Lab Result Letter Log. 5 Reviews online medical questions from donors and organizes a response through the Corporate Medical Director as appropriate. Provides telephone and online support to centers that have questions regarding donor suitability, unit disposition, and Medical Operations’ procedures. 6 Reviews standard operating procedures for completeness and accuracy. Develops standard operating procedures that support Medical Operations’ projects and/or satisfy FDA, GHA, OSHA, or other regulations. Interfaces with multi-disciplinary teams including; Document Systems, Regulatory Affairs, Quality Assurance, Plasma Operations, and IT when necessary. 7 Publishes quarterly Medical Operations newsletter in an effort to build a strong relationship between the center medical staff and corporate Medical Operations. The newsletter relays important information related to the plasma pheresis process and provides information to help enhance the performance of the center medical staff and the quality of our plasma. 8 Tracks the status of various Medical Operations activities, including: projects, document development, and medical staff approvals. 9 Assists Divisional Medical Director with other projects as necessary ***** APPLICATION INSTRUCTIONS: Apply Online: https://www.cslplasma.com/careers
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