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Medical Director

2 months ago

Augusta, Maine, United States KEDPlasma USA Full time
Job Summary

As a Medical Director at KEDPlasma USA, you will be responsible for ensuring the safety and well-being of donors through thorough medical evaluations, informed consent, and management of donor reactions. You will operate within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR, providing independent medical judgment and discretion for issues related to donor safety, health, and suitability for plasmapheresis and/or immunization. You will also be responsible for leading plasma collection center employees, upholding KEDRION values, and ensuring strategies meet professional standards through policies and procedures, and Federal, State, and local guidelines and/or regulations.

Main Responsibilities
  • Observe and approve Physician Substitute initial and/or annual recertification, reviewing the initial, at 6 – months and annual employee training for the performance of CLIA designated moderate complexity tests, using independent medical judgment to evaluate training and performance.
  • Review the donor's accumulated laboratory data and collection records as required in 21 CFR to determine the donor's continued suitability.
  • Review and approve abnormal SPE/RPR Test Profiles and reviews all other abnormal laboratory test results on a weekly basis.
  • Determine the status of donor suitability for donors with abnormal laboratory test results.
  • Review 10% of the weekly SPE/RPR Test Profiles completed by each Physician Substitute for the Medical Review as required.
  • Comply with all facility SOPs, FDA and EU regulations, OSHA, PPTA, CLIA and COLA requirements and properly document said compliance.
  • Ensure a Physician is present in the premises while donor red cell immunization procedures are being performed.
  • Determine donor suitability when screening values fall into the borderline areas (e.g., elevated blood pressure, elevated pulse, weight loss) when applicable.
  • Refer donors to other medical facilities or physicians as necessary (e.g., donors with infectious disease markers such as Anti-HCV, Anti-HIV 1/2, HBsAg, HIV-1 NAT or HCV NAT reactive test results) and serve as a liaison between the plasmapheresis facility and such medical facilities and physicians.
  • Assure donor satisfaction through appropriate physician interaction and responsiveness to donor needs when needed.
  • Observe staff, center activity, and practices, and communicate compliance issues to appropriate individuals when needed.
  • Propose revisions to SOPs and Company practices when appropriate.
  • Review and approve the CLIA defined moderate complexity test procedures.
  • Select suitable plasmapheresis donors pursuant to the Physician's medical education and experience and in accordance with SOP, FDA, PPTA, OSHA, CLIA, cGMP by utilizing informed consent administration, assessing medical history, and administering physical examinations if applicable.
  • Explain informed consents for plasmapheresis and immunization to donors based upon the Physician's judgment and discretion and in compliance with 21 CFR 630.5 including but not limited to explanation of the plasmapheresis procedure, hazards, potential adverse reactions, and specific immunization programs if applicable.
  • Answer and discuss any donor questions and ensure the donor is given a clear opportunity to refuse participation when needed.
  • Provide appropriate level of care and medical judgment when assessing issues related to unusual or severe donor reactions if applicable.
  • Exercise medical judgment by assessing donor situations and institutes appropriate management procedures in accordance with current SOP and the center's standing orders.
  • Administer and/or supervise administration of immunizations, order immunizations, and utilizes medical expertise to analyze candidates and/or donor's reactions if applicable.
  • Review the QC/QA/proficiency testing reports for timely and appropriate actions on moderate complexity procedures for test problems.
  • Assure on-call availability to provide consultation on donor suitability and medical emergencies when needed.
Managerial / Supervisory
  • Manage and oversee direct reports.
  • Discipline and terminate employees following approved company guidelines.
  • Establish and communicate performance standards to meet or exceed standards.
  • Coach others for success and to meet established goals and/or standards.
  • Recruit, interview, hire, and train employees, as needed.
  • Oversee work assignments to include supporting and rearranging workload of direct reports.
  • Provide constructive and timely performance evaluations including motivating and evaluating employees based on established performance standards.
  • Promote staff retention by creating an open, positive, and supportive work environment.
  • Receive, investigate, and respond to employee grievances. Involves and obtains guidance from supervisor and human resources when needed.
Requirements
  • Licensed Doctor of Medicine (M.D. or D.O.) from an accredited medical school required.
  • Currently licensed in the state in which he or she will be providing services required.
  • Currently CLIA certification required or willing to complete course requirements prior to execution of contract.
Work Environment

Work is primarily light in nature, with exerting up to 25lbs of force occasionally and/or a negligible amount of force frequently to lift, carry, push, pull or otherwise move objects. Use of fingers to type and / or enter numbers on keyboards, keypads, etc. along with grabbing object(s). Additionally includes, reaching, handling, talking, hearing, bending, stooping, and walking. Involves sitting, standing, and walking most of the time.

Primarily inside with well-lighted and well-ventilated areas.

Exposure to Blood Borne Pathogens.