Elisabeth Marker
Pharmacy Resident at UPMC St. Margaret- Claim this Profile
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Spanish Elementary proficiency
Topline Score
Bio
Experience
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UPMC St. Margaret
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United States
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Medical Practices
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1 - 100 Employee
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Pharmacy Resident
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Jun 2022 - Present
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Virginia Commonwealth University
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United States
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Higher Education
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700 & Above Employee
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Graduate Student
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Aug 2018 - Mar 2023
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3M Health Care
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Hospitals and Health Care
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1 - 100 Employee
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Regulatory Affairs Coordinator
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Mar 2014 - Mar 2023
• Collaborate with company personnel and contract manufacturers to prepare regulatory documents for nearly 500 different medical devices and combination drug/devices • Analyze rapidly changing regulatory requirements in USA and over 60 other countries, summarize them and prepare reports, and coordinate compliance efforts • Support regulatory submissions by researching requirements, submitting FOIA requests for competitors’ products, and liaising with FDA and company… Show more • Collaborate with company personnel and contract manufacturers to prepare regulatory documents for nearly 500 different medical devices and combination drug/devices • Analyze rapidly changing regulatory requirements in USA and over 60 other countries, summarize them and prepare reports, and coordinate compliance efforts • Support regulatory submissions by researching requirements, submitting FOIA requests for competitors’ products, and liaising with FDA and company stakeholders • Monitor, interpret, and efficiently communicate changing federal regulations to multiple departments within the business to inform company strategy • Independently manage projects such as full document audits of 3M and contract manufacturers around the world Show less • Collaborate with company personnel and contract manufacturers to prepare regulatory documents for nearly 500 different medical devices and combination drug/devices • Analyze rapidly changing regulatory requirements in USA and over 60 other countries, summarize them and prepare reports, and coordinate compliance efforts • Support regulatory submissions by researching requirements, submitting FOIA requests for competitors’ products, and liaising with FDA and company… Show more • Collaborate with company personnel and contract manufacturers to prepare regulatory documents for nearly 500 different medical devices and combination drug/devices • Analyze rapidly changing regulatory requirements in USA and over 60 other countries, summarize them and prepare reports, and coordinate compliance efforts • Support regulatory submissions by researching requirements, submitting FOIA requests for competitors’ products, and liaising with FDA and company stakeholders • Monitor, interpret, and efficiently communicate changing federal regulations to multiple departments within the business to inform company strategy • Independently manage projects such as full document audits of 3M and contract manufacturers around the world Show less
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Pace Analytical
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United States
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Environmental Services
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100 - 200 Employee
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Regulatory Data Specialist
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Aug 2011 - Mar 2014
• Coordinated efforts to request, evaluate, and approve regulatory forms from suppliers of raw materials • Processed supplier documents according to client’s document management policies • Authored various technical documents such as Standard Operating Procedures and Material Safety Data Sheets • Trained new employees on client database and proper document handling procedures • Coordinated efforts to request, evaluate, and approve regulatory forms from suppliers of raw materials • Processed supplier documents according to client’s document management policies • Authored various technical documents such as Standard Operating Procedures and Material Safety Data Sheets • Trained new employees on client database and proper document handling procedures
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Northern Michigan University
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United States
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Higher Education
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700 & Above Employee
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Receptionist in Printing Services
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Aug 2009 - May 2011
• Developed strong customer service skills by greeting and helping clients to place orders and answer any questions about the printing process • Provided customer service support via telephone, email, and in person • Entered orders into a database and conducted client billing • Assisted in the production and delivery stages, in the mail room, and the warehouse as needed
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Undergraduate Research Assistant
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May 2009 - Aug 2009
• Isolated and quantified protein expressed in bacteria • Sterilized hazardous materials using an autoclave • Presented research and findings with research team at a symposium
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Education
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Virginia Commonwealth University
Doctor of Pharmacy - PharmD, Pharmacy -
Virginia Commonwealth University
Doctor of Pharmacy - PharmD, Pharmacy -
Northern Michigan University
Bachelor of Arts - BA, Forensic Biochemistry -
Northern Michigan University
Bachelor of Arts (B.A.), Forensic Chemistry