Contract Center Medical Director/Center Physician - CSL Plasma
Tucson, AZ
About the Job
RESPONSIBILITIES
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 training, CLIA proficiency testing for hematocrit and total protein, and signed of logs involving standardization takes place.
May be required to provide direct oversight of total protein testing.
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 and observes MSAs periodically 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 signs off on Medical Staff Associates activities weekly, including health assessment observations.
6 Meets with Medical Staff Associates at least once a month to discuss medically related topics. Documents each meeting. May 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.
7 Responds to inquiries regarding donor suitability for 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 signs moderate and severe medical incident reports prior to donor being permitted to resume donating. Reviews abnormal test results including abnormal protein electrophoresis (PE) test results and donor record files. Reviews normal PE 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.
12 Determines donor suitability following donor adverse reactions (DAE). Maintains current knowledge of infectious disease markers (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.
JOB SPECIFICATIONS
Provide minimum hiring requirements, specialized knowledge, and other considerations required
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
If applicable for state regulations, must meet all state specific educational requirements.
Experience
One year of residency training as an MD or OD
• If applicable for state regulations, must meet all state specific experience requirements.
Additional Comments
Familiarity with Code of Federal Regulations (CFR) and all relevant procedures in the company Plasma Operating Procedures
Working 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
travel to multiple centers other than primary location may be required.
Frequent standing and walking
Fast paced environment with frequent interruptions
Note: 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.
Our Benefits
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care (https://www.cslplasma.com/careers/how-do-we-care-for-you-as-csl-plasma) at CSL.
About CSL Plasma
CSL 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 CSL Plasma (https://www.cslplasma.com/about-csl-plasma) .
We want CSL to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion (https://www.cslplasma.com/careers/diversity-and-inclusion) at CSL.
Do work that matters at CSL Plasma!
R-076024
CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement
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 training, CLIA proficiency testing for hematocrit and total protein, and signed of logs involving standardization takes place.
May be required to provide direct oversight of total protein testing.
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 and observes MSAs periodically 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 signs off on Medical Staff Associates activities weekly, including health assessment observations.
6 Meets with Medical Staff Associates at least once a month to discuss medically related topics. Documents each meeting. May 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.
7 Responds to inquiries regarding donor suitability for 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 signs moderate and severe medical incident reports prior to donor being permitted to resume donating. Reviews abnormal test results including abnormal protein electrophoresis (PE) test results and donor record files. Reviews normal PE 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.
12 Determines donor suitability following donor adverse reactions (DAE). Maintains current knowledge of infectious disease markers (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.
JOB SPECIFICATIONS
Provide minimum hiring requirements, specialized knowledge, and other considerations required
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
If applicable for state regulations, must meet all state specific educational requirements.
Experience
One year of residency training as an MD or OD
• If applicable for state regulations, must meet all state specific experience requirements.
Additional Comments
Familiarity with Code of Federal Regulations (CFR) and all relevant procedures in the company Plasma Operating Procedures
Working 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
travel to multiple centers other than primary location may be required.
Frequent standing and walking
Fast paced environment with frequent interruptions
Note: 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.
Our Benefits
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care (https://www.cslplasma.com/careers/how-do-we-care-for-you-as-csl-plasma) at CSL.
About CSL Plasma
CSL 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 CSL Plasma (https://www.cslplasma.com/about-csl-plasma) .
We want CSL to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion (https://www.cslplasma.com/careers/diversity-and-inclusion) at CSL.
Do work that matters at CSL Plasma!
R-076024
CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement
Source : CSL Plasma