Center Medical Director (CMD)
Company: CSL Plasma
Location: Tempe
Posted on: January 11, 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 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 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, Tempe , Center Medical Director (CMD), Executive , Tempe, Arizona
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