Center Medical Director (CMD)
Company: CSL Plasma
Location: National City
Posted on: January 12, 2021
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Job Description:
About CSLWith operations in 35+ nations and -27,000 employees
worldwide, CSL is driven to develop and deliver a broad range of
lifesaving therapies to treat disorders such as hemophilia and
primary immune deficiencies, and vaccines to prevent influenza. Our
therapies are also used in cardiac surgery, organ transplantation
and burn treatment.CSL is the parent company of CSL Behring and
Seqirus. CSL Behring is a global leader in the protein
biotherapeutics industry, focused on bringing to market
biotherapies used to treat serious and often rare conditions. CSL
Behring operates CSL Plasma, one of the world's largest collectors
of human plasma, which is used to create CSL's therapies. Seqirus
is one of the largest influenza vaccine companies in the world and
is a transcontinental partner in pandemic preparedness and a major
contributor to the prevention and control of influenza globally.We
invite you to take a look at the many career possibilities
available around the globe and consider building your promising
future at CSL by becoming a member of our team!Job
DescriptionProvides 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).* * 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 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 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* 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.#CB
Keywords: CSL Plasma, National City , Center Medical Director (CMD), Executive , National City, California
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