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Corporate Attorney-Contracts |
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Staff Veterinarian #08-025R |
| Staff Veterinarian #08-025R
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Manager, Business Development |
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SENIOR CLINICAL DATA MANAGER |
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Experience:
The candidate ... |
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Manager Medical Supplies
| Details |
Country: USA
Location: Maryland-Montgomery County MD
Total applied: 6 |
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Manager Medical Supplies
Manager Medical Supplies Our client is a leading biotechnology company. They have asked us to assist them in their search for a Manager Medical Supplies. The major duties & responsibilities of the Manager Medical Supplies will include the following:· Maintain & expand close cross-functional relationships while proactively seeking information pertaining to clinical studies in order to best design, plan, implement & direct the clinical trial material (CTM) activities for assigned clinical projects;· Complete long-range forecast planning for CTM by interacting with other stakeholder departments in the clinical trial material process;· Negotiate & share information cross-functionally to ensure CTM commitment & milestone timelines are agreed & maintained to best meet the clinical objectives;· Communicate internally & externally to company (CROs, couriers, drug depots, etc) to ensure smooth and on-time delivery of CTM for clinical studies;· Identify critical issues relative to CTM administration, including toxicity & compatibility, and advise the Project Team on resolution;· Assist the clinical team with such study-related activities as protocol creation & investigative site training (presentations at Investigator Meetings, preparing the CTM manual, etc);· Coordinate Quality Assurance (QA) activities relative to drug inventory & distribution, vendor selection & monitoring, & all other activities related to cGMP, GCP, & ICH guidelines;· Maintain current, accurate & complete files (hard copy & electronic) of all study documentation related to CTM;· Maintain oversight of expiry dating of all CTM utilized in assigned clinical projects;· Maintain oversight of the activities related to processing complaints or inquiries pertaining to CTM received from sites, depots or couriers;· Create & maintain project budgets for assigned clinical projects;· Communicate project needs to outside vendors via requests for proposal (RFP) or other appropriate method, monitor the activities of vendors selected & review & approve vendor invoices;· Assure that all vendor legal documents (Confidentiality, Master Service Agreements, contracts, etc) are appropriately processed through the company contracts procedure;· Mentor, develop & supervise the daily activities (label creation & printing, creation & review of packaging batch records, CTM shipment requests, CTM returns & reconciliation) of Clinical Supply Specialists;· Attend & participate in departmental meetings;· Assist in creation & maintenance of department SOPs, working practice documents (WPD) & other procedural documentation; We seek candidates who meet the following qualifications:· Bachelor’s degree (prefer Bachelor’s degree in pharmacy)· At least 7 years direct clinical supply management experience or 8 years related clinical trial experience. Some experience with international trials is a plus. Prefer Biotech industry experience 1+ years experience in the preparation or administration of injectable drugs.· Demonstrated people, resource &/or project management experience of at least 3 years.· Solid understanding of drug development process· Familiarity with cGMP, GCP, & ICH guidelines as related to CTM labeling, packaging & distribution.· Must be highly organized & possess excellent attention to detail.· Must be a self-starter with strong oral, written, & interpersonal communication skills as well as a proven ability to work in a team environment.· Must have good computer skills (MS Office suite)· Must have ability to travel approximately 5 – 10% as needed. Do you have the skills and experience we seek and want to advance your career with an industry leader? If so, please email your resume as a Word attachment to dan@jobsrecruiting.com , reference code 2189-M. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email. Fairway Consulting Group is a leading executive search firm dedicated to the pharmaceutical, biotech, and medical device industries. www.fairwayconsultinggroup.com or www.jobsrecruiting.com MRINetwork is the largest and most successful search organization in the world. Each MRINetwork office is a single point of contact to over 1,100 offices in more than 37 countries, our candidates have access to the right jobs virtually anywhere in the world. LOCATION: US-MD-Montgomery County JOB CATEGORY: Biotech/R&D/Science TYPE: Full Time, Employee JOB REFCODE: 2189-M COMPANY: Fairway Consulting Group ADDRESS: 300 Merrick Road - Suite 404Lynbrook,NY 11563 PHONE: 516 596-2800 EMAIL: Apply by Email
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