Medical Director/Center Physician
3 weeks ago
Job Summary: We are seeking a highly skilled and experienced Medical Director/Center Physician to join our team at CSL Plasma. As a key member of our medical staff, you will be responsible for providing medical oversight and ensuring compliance with applicable Federal and State regulations.
Key Responsibilities:
- Provide medical oversight and ensure compliance with applicable Federal and State regulations.
- Serve as the primary physician for reporting to the Food and Drug Administration.
- Monitor medical compliance of the center and ensure adherence to cGMPs.
- Train and evaluate Medical Staff Associates, including their training and certification.
- Functionally direct the Center Medical Staff and provide training to other center staff on medically related procedures and practices.
- Review and sign Medical Staff Associates notebooks weekly, including a review of approximately one out of five screening medical evaluations and unsuitable test result communications.
- Meet with Medical Staff Associates at least once a month to discuss medically related topics and document each meeting.
- Act as a liaison between the Corporate or Divisional Medical Director and the Center Medical Staff, including preparation of monthly reports and periodic conference calls.
- Respond to questions and phone calls regarding donor suitability for long-term serial plasmapheresis.
- Conduct confidential and effective interviews with donors to obtain information in a variety of situations.
- Maintain confidentiality with respect to employee, donor, and center records reviewed during the course of all duties.
- Responsible for overseeing maintenance of medical supplies and other emergency equipment.
- Review and sign moderate and severe medical incident reports prior to donor being permitted to resume donating.
- Review abnormal test results, including abnormal serum protein electrophoresis (SPE) test results, and donor record files.
- Review normal SPE test results following an abnormal one and document approval to resume donating.
- Assure the health and safety of donors participating in the non-red blood cell immunization programs, if applicable.
- Monitor donor clinical response to immunizations, when applicable.
- Oversee hyper-immune programs, if applicable.
- Determine donor suitability following adverse reactions in consultation with the Corporate or Divisional Medical Director.
- Maintain current knowledge of infectious disease markets (i.e. HIV, HBV, HCV, syphilis, etc.).
- Perform additional services as and when requested by the company.
Requirements:
- MD or DO degree from an accredited medical or osteopathic school.
- Maintain a current and active medical license in the state in which the Center is located.
- One year of residency training as an MD or OD.
- Familiarity with Code of Federal Regulations (CFR) and all relevant procedures in the company Plasma Operating Procedures.
Working Conditions:
- Frequently exposed to hazardous chemicals, extreme temperatures, and to blood-borne pathogens.
- Required to wear Personal Protective Equipment while performing specific tasks or in certain areas.
- Overnight travel required up to 75% of the time without lengthy lead-time.
- Frequent standing and walking.
- Fast-paced environment with frequent interruptions.
CSL Plasma is an Equal Opportunity Employer: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin, or other legally protected classifications.
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