Clinical Supplies Specialist II/Sr. Clinical Supplies Specialist

Position Summary for the Clinical Supply Specialist II:The Clinical Supply Specialist II (CSS II) coordinates the packaging & labeling activities required to provide Clinical Trial Material (CTM) for clinical trials in time for scheduled First-Patient-In (FPI) date. This person is also responsible for participating in the coordination of the CTM returns & reconciliation process to provide for appropriate destruction of CTM within a defined time period following the close-out of a study.Major Duties and Responsibilities (including supervising others):Attend & participate in project team meetings to build cross-functional relationships, gather information on study progress & share information on CTM status.Maintain current, accurate & complete CTM study files (hard copy & electronic, as appropriate)Assist in maintaining oversight of inventory of all filled-lots & labeled-lots (CTM) from date of release by Quality Assurance (QA) through final reconciliation & closeout of trialReview CTM shipment requests for accuracy & completeness prior to processingProvide updates to timeline & milestone information in relevant tracking tool(s) for communication to QA, CRPS mgmt, & vendorsCoordinate & document activities related to label creation (including translations), approval (Clinical, QA, Regulatory Affairs (RA), etc), printing & receipt at vendorCoordinate & document activities related to packaging/labeling of CTM (i.e. batch record production & review, scheduling production with vendor, etc.)Coordinate & document activities related to the production of distribution and returns protocols/summaries, accountability & returns documentation, & other CTM-related documentation used by the vendor or clinical siteMaintain oversight of the returns process (including stock recovery) to aid in documenting full reconciliation of CTMCoordinate & document activities surrounding complaints, excursions, or deviations received from sites or vendorsAssist in the review & preparation of departmental SOPs & WPDsSupport department projectsProvide back-up support to other CRPS staff members as requiredRequirements/Qualifications:Education: Requires a High School diploma with minimum 4 years related experience. Prefer Bachelor’s degree with 2 years CTM experience or 3 years related experienceExperience: Prefer experience in the Biotechnology &/or Pharmaceutical industrySpecial Skills/Abilities: Proficient in Microsoft Outlook, Word & Excel. Must be highly organized & possess excellent attention to detail. Must have strong oral, written & interpersonal communication skills as well as a proven ability to work in a team environment.Job Complexity: Requires juggling multiple projects with varying priorities. Requires ability to recognize activities or events that may critically affect the availability of CTM & act on or relay that information to appropriate level of management.Supervision: Follows established procedures. The Senior Clinical Supply Specialist (Sr CSS) participates in the development of packaging & labeling design & fulfillment strategies for Clinical Trial Material (CTM) to ensure CTM manufacture occurs in a timely manner & clinical trial First-Patient-In (FPI) dates are met.Major Duties and Responsibilities (including supervising others):Attend & participate in project team meetings to build cross-functional relationships, gather information on study progress & share information on CTM status.Maintain current, accurate & complete CTM study files (hard copy & electronic, as appropriate)Assist in maintaining oversight of inventory of all filled-lots & labeled-lots (CTM) from date of release by Quality Assurance (QA) through final reconciliation & closeout of trialReview CTM shipment requests for accuracy & completeness prior to processingProvide updates to timeline & milestone information in relevant tracking tool(s) for communication to QA, CRPS mgmt, & vendorsCoordinate & document activities related to label creation (including translations), approval (Clinical, QA, Regulatory Affairs (RA), etc), printing & receipt at vendorCoordinate & document activities related to packaging/labeling of CTM (i.e. batch record production & review, scheduling production with vendor, etc.)Coordinate & document activities related to the production of distribution and returns protocols/summaries, accountability & returns documentation, & other CTM-related documentation used by the vendor or clinical siteMaintain oversight of the returns process (including stock recovery) to aid in documenting full reconciliation of CTMCoordinate & document activities surrounding complaints, excursions, or deviations received from sites or vendorsAssist in preparing the Request for Proposal (RFP) & reviewing quotes received for CTM packaging & labeling related activitiesAssist with preparing presentations for Investigator Meetings, CRA training, site initiations or other similar training situationsAssist in preparing protocol-specific CTM Manuals for use by clinical sitesAssist in reviewing vendor invoices for accuracyAssist in training & mentoring new Clinical Supply SpecialistsAssist in the review & preparation of departmental SOPs & WPDsSupport department projectsProvide back-up support to other CRPS staff members as requiredRequirements/Qualifications:Education: Requires a High School diploma with minimum 6 years related experience. Prefer Bachelor’s degree with 4 years CTM experience or 5 years related experienceExperience: Prefer experience in the Biotechnology &/or Pharmaceutical industry & some project management experience. Must have some previous experience working under cGMP, cGCP &/or cGLP.Special Skills/Abilities: Proficient in Microsoft Outlook, Word, Excel, & Power Point. Must be highly organized & possess excellent attention to detail. Must have strong oral, written & interpersonal communication skills as well CLICK HERE TO APPLY MedImmune, Inc. is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law. Job Title: Clinical Supplies Specialist II/Sr. Clinical Supplies Specialist Location:  US-MD-Gaithersburg Status:  Full Time, Employee Job Category:  Sales/Retail/Business Development