About The Position

Provides medical oversight to Medical Staff Associates, including the training of other physicians and Medical Staff Associates. Usually serves as the primary center physician registered as the Laboratory Director with the Food and Drug Administration (FDA). Serves as the primary physician for reporting to the Food and Drug Administration and in such capacity provides medical oversight in compliance with applicable Federal and State regulations including the applicable sections of Title 21 of the Code of Federal Regulations and monitors medical compliance of the center. Either serves as or delegates to another appropriate physician the duties of 'laboratory director', 'technical consultant', or 'clinical consultant' as prescribed by the Clinical Laboratory Improvement Act of 1988 regulations (CLIA). Assures that CLIA/COLA training, CLIA/COLA proficiency testing for hematocrit and total protein, and signed of logs involving standardization takes place. Reviews, understands, and complies with all CSL Plasma Services policies and procedures in the performance of services. Maintains high medical standards and ensures that cGMPs are adhered to through involvement with center management, center quality unit, and overall center activities. Is physically present at the center for agreed upon hours.

Requirements

  • MD or DO degree from an accredited medical or osteopathic school.
  • Must 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.

Responsibilities

  • Provides medical oversight to Medical Staff Associates, including their training.
  • Trains other physicians.
  • Evaluates newly trained Medical Staff Associates for completion of training and recommendation for certification by Regulatory Affairs.
  • Functionally directs the Center Medical Staff.
  • Provides training to other center staff on medically related procedures and practices.
  • Reviews and signs Medical Staff Associates notebooks weekly.
  • Meets with Medical Staff Associates at least once a month to discuss medically related topics.
  • Documents each meeting.
  • Meets with the Center Manager and Compliance Specialist during weekly visits to the center.
  • Serves as a member of the Quality Assurance Team.
  • Acts as a liaison between the Corporate or Divisional Medical Director and the Center Medical Staff.
  • Responds to questions and phone calls regarding donor suitability for long-term serial plasmapheresis.
  • Conducts confidential and effective interviews with donors to obtain information in a variety of situations.
  • Maintains 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.
  • Reviews and signs moderate and severe medical incident reports prior to donor being permitted to resume donating.
  • Reviews abnormal test results including abnormal serum protein electrophoresis (SPE) test results.
  • Assures the health and safety of donors participating in the non-red blood cell immunization programs.
  • Monitors donor clinical response to immunizations, when applicable.
  • Submits monthly report to Divisional (or Corporate) Medical Director.
  • Determines donor suitability following adverse reactions in consultation with the Corporate or Divisional Medical Director.

Benefits

  • Encouragement to prioritize well-being.
  • Commitment to inclusion and belonging.
  • Support for individuals with disabilities during the application process.

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What This Job Offers

Job Type

Full-time

Career Level

Senior

Education Level

Ph.D. or professional degree

Number of Employees

5,001-10,000 employees

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