Medical Director

Ubertal Inc.; United States; On-site; USD 150,000 - 200,000; Full time

Job summary

A healthcare provider organization in the United States seeks a Center Physician to provide medical oversight and training to medical staff, ensuring compliance with FDA regulations. Candidates must have an MD or DO degree and an active medical license. Key responsibilities include monitoring donor suitability and managing medical incidents. This role offers a contract position at a senior director level.

Qualifications

• Must maintain a current and active medical license in the state.
• Responsible for compliance with FDA regulations.
• Experience with medical supplies and emergency equipment management.

Responsibilities

• Provides medical oversight and training to medical staff.
• Serves as the liaison between the center and corporate medical directors.
• Monitors donor suitability and responds to medical incidents.

Skills

Medical oversight

Physician training

Regulatory compliance

Patient interviews

Confidentiality

Education

MD or DO degree

Job description

Be among the first 25 applicants.

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).

Job 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.

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 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.

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 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 and donor record 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

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.

Experience

One year of residency training as an MD or DO.

Seniority level: Director

Employment type: Contract

Job function: Health Care Provider

Industries: IT Services and IT Consulting