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Job ID :
50419BR
Location :
US - Maryland - Rockville
:
Job Description
  • Reviewing of Certificate of Analysis and stability reports of all study products
  • Study the current inventory management system and Internet ordering system and work with IT department to develop a new platform
  • Review all temperature excursions and contact manufacturers to obtain stability information and send notifications to clinical research sites regarding suitability of products.
  • Evaluate protocols for drug supplies in clinical research protocols and coordinate the acquisition of clinical supplies from manufacturers/suppliers.
  • Provide drug forecast to manufactures to meet the supply needs of ongoing protocols.
  • Negotiate and establish subcontractor support, when needed.
  • Process pharmacy plan approvals received from Division of AIDS (DAIDS)
  • Maintain the entire database of clinical research sites
  • Enter data into the CPIMS system and forward the data to Clinical Site Information Office to be entered in DAIDS enterprise system
  • Review site visit reports including but not limited to Auditing and Monitoring reports.
  • Review and help resolve issues for CRS Pharmacy Establishment Plan (PEP) for approval.
  • Correspond with DAIDS to discuss and resolve any site issues.
  • Prepare tables and charts to aid Pharmaceutical Affairs Branch (PAB) in tracking site compliance issues.
  • Develop a variety of forms such as a PEP Approval Check List, Approval Notification Letters, etc for review and tracking purposes.
  • Assist PAB in resolving issues by providing insight and advice.
  • Meet in person at PAB request when required.
  • Write new and update current SOPs

EXPERIENCE REQUIREMENTS:
  • MS degree in pharmacy/science field, preferably Ph.D in chemistry. Two years’ experience in the field of pharmacy or health care administration related duties. Hospital pharmacy experience is a plus.
  • Excellent computer skills using Microsoft Word, Excel and Power Point; and
  • Good English oral and written communication skills
  • Ability to develop a working relationship with a wide variety of people.
  • Capable of resolving issues without promoting conflict.
  • Strong spreadsheet skills so that information can be retrieved and reported readily.




Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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