Center Medical Director (CMD)
Company: CSL Plasma Inc.
Posted on: March 19, 2023
Job DescriptionJob Description SummaryProvides 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 of logs involving standardization takes
- 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
- 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
- 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
- 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
- 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
- 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 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.#CBOur BenefitsWe encourage you to make
your well-being a priority. It's important and so are you. Learn
more about at CSL.About CSL -PlasmaCSL 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. We are committed to our work because lives depend on
us. Learn more about .We want CSL to reflect the world around usAs
a global organization with employees in 35+ countries, CSL embraces
diversity and inclusion. Learn more about at CSL.Do work that
matters at CSL Plasma!
Keywords: CSL Plasma Inc., Wilmington , Center Medical Director (CMD), Executive , Dover, Delaware
Didn't find what you're looking for? Search again!
Loading more jobs...