Medical Director/Physician Lead
hace 2 días
We are seeking a skilled Medical Director/Physician Lead to join our team at CSL Plasma Inc. As a key member of our organization, you will be responsible for providing medical oversight and ensuring compliance with regulatory requirements.
Key Responsibilities
- Serves as the primary physician for reporting to the FDA and provides medical oversight in compliance with applicable Federal and State regulations, including Title 21 of the Code of Federal Regulations.
- Evaluates and ensures compliance with CLIA/COLA training, proficiency testing for hematocrit and total protein, and signed logs involving standardization.
- Reviews and understands all company policies and procedures, maintaining high medical standards and ensuring adherence to cGMPs through involvement with center management, quality unit, and overall center activities.
- Provides medical guidance to Medical Staff Associates, including training and evaluation, and recommends certification by Regulatory Affairs.
- Reviews and signs notebooks weekly, including a review of approximately one out of five screening medical evaluations and unsuitable test result communications.
- Meets with Medical Staff Associates monthly to discuss medically related topics, documenting each meeting.
- Acts as a liaison between the Corporate or Divisional Medical Director and the Center Medical Staff, preparing monthly reports and participating in periodic conference calls.
- Responds to donor suitability questions and conducts confidential interviews to obtain information in various situations.
- Maintains confidentiality regarding employee, donor, and center records reviewed during duties.
Education
A MD or DO degree from an accredited medical or osteopathic school, with a current and active medical license in the state where the Center is located.
Experience
One year of residency training as an MD or DO, with familiarity with the Code of Federal Regulations (CFR) and relevant company Plasma Operating Procedures.
Salary and Benefits
This role offers a competitive salary of $250,000 per year, along with additional benefits, including health insurance, retirement plans, and paid time off.
About Us
CSL Plasma Inc. is a global organization dedicated to collecting human plasma to help patients with rare and serious diseases live normal lives.
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