Contract Center Medical Director/Center Physician
Company: CSL Plasma
Location: East Providence
Posted on: January 13, 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).1. 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.2. 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.3. 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.4. 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.5.
Reviews and signed Medical Staff Associates notebooks weekly,
including a review of approximately one out of five screening
medical evaluations and unsuitable test result communications.6.
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.7. 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.8. 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.9. 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 recordfiles. Reviews normal SPE test results following an
abnormal one and documents approval to resume donating.10. 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.11. 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.12. 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.)13. 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.14.
Performs additional services as and when requested by the
company.EducationMD 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 locatedExperience ---
One year of residency training as an MD or ODAdditional Comments
--- Familiarity with Code of Federal Regulations (CFR) and all
relevant procedures in the company Plasma Operating
ProceduresWorking Conditions (physical & mental requirements) ---
Ability to make decisions which have significant impact on the
department's creditability, operations and services--- Ability to
formulate complex and comprehensive materials such as authoritative
reports of major scope and impact, etc. and/or to make formal
presentations--- Frequently exposed to hazardous chemicals, extreme
temperatures and to blood borne pathogens--- Required to wear
Personal Protective Equipment while performing specific tasks or in
certain areas--- Overnight travel required up to 75% of the time
without lengthy lead-time--- Frequent standing and walking--- Fast
paced environment with frequent interruptionsNote: 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. CSL is introducing a new Career
Framework, which will provide a common, global infrastructure for
managing jobs and serve as a foundation for future career
development and competitive rewards. Certain components of this job
description, including Title and Level are subject to change
relative to applicable local laws. Your Talent Acquisition
Consultant will discuss the pending changes with you.
Keywords: CSL Plasma, East Providence , Contract Center Medical Director/Center Physician, Executive , East Providence, Rhode Island
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