Center Medical Director - Rialto, CA, United States - CSL Behring LTD

Description

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.

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. Provides medical oversight to Medical Staff Associates, including their training, although such training may be delegated to an approved Medical Staff Associate. 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 signed Medical Staff Associates notebooks weekly, including a review of approximately one out of five screening medical evaluations and unsuitable test result communication.
• Meets with Medical Staff Associates at least once a month to discuss medically related topics. Documents each meeting. 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, which includes preparation of monthly reports and periodic conference calls.
• Responds to questions and phone calls regarding donor suitability for long-term serial plasmapheresis. Responds to calls from and provides instruction to Center Medical Staff with donor suitability questions. Conducts confidential and effective interviews with donors to obtain information in a variety of situations. Interviews donors with positive STS/negative FTA and documents approval to resume donating.
• Responsible for overseeing maintenance of medical supplies ad other emergency equipment.
• Reviews and sings moderate and severe medical incident reports prior to donor being permitted to resume donating. Reviews normal SPE test results following an abnormal one and documents approval to resume donating.
• Assures the health and safety of donors participating in the non-red blood cell immunization programs, if applicable. Performs qualifying evaluation (e.g. administers consents, medical history and physical exam) on donors before enrollment; Submits monthly report to Divisional (or Corporate) Medical Director.
• Determines donor suitability following adverse reactions in consultation with the Corporate or Divisional Medical Director. Maintains current knowledge of infectious disease markets (i.e. HIV, HBV, HCV, syphilis, etc.)
• May perform Center Physician functions including but not limited to notifying donors of unsuitable test results, performing screening medical evaluations, assessing results of donor screening and laboratory tests to determine a donor's initial and continued suitability for plasmapheresis, explaining informed consent materials to donors.
• Performs additional services as and when requested by the company.

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.

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.

#We encourage you to make your well-being a priority. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.