Medical Director
1 month ago
We are seeking a highly skilled Medical Director to join our team at CSL Plasma. As a Medical Director, you will be responsible for providing medical oversight and ensuring compliance with applicable Federal and State regulations.
You will serve as the primary physician for reporting to the Food and Drug Administration and provide medical oversight in compliance with applicable Federal and State regulations, including the applicable sections of Title 21 of the Code of Federal Regulations.
You will also be responsible for monitoring medical compliance of the center, ensuring that CLIA/COLA training, CLIA/COLA proficiency testing for hematocrit and total protein, and signed of logs involving standardization takes place.
Additionally, you will review, understand, and comply with all CSL Plasma Services policies and procedures in the performance of services.
You will maintain high medical standards and ensure 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.
Provides medical oversight to Medical Staff Associates, including their training, although such training may be delegated to an approved Medical Staff Associate.
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 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.
Meets with the Center Manager and Compliance Specialist (or designees) 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, 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.
Maintains confidentiality with respect to employee, donor and center records reviewed during the course of all duties. 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 abnormal test results including abnormal serum protein electrophoresis (SPE) test results and donor record lc-PD-09195 Page 2 files.
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. Monitors donor clinical response to immunizations, when applicable. Oversees hyper-immune programs, if applicable.
For red cell recipients in the Anti-D Program, if applicable:
Performs qualifying evaluation (e.g. administers consents, medical history and physical exam) on donors before enrollment; provides review and approval for red blood cell immunization; is present when red cell immunizations are given. 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.
Education and Experience
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.
Our Commitment to Diversity and Inclusion
CSL Plasma is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment that reflects the diversity of our patients and communities.
About CSL Plasma
CSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives.
Our Benefits
We offer a comprehensive benefits package, including medical, dental, and vision insurance, as well as a 401(k) plan and paid time off.
How to Apply
Apply now to join our team and make a difference in the lives of patients with rare and serious diseases.
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