Clinical Regulatory Affairs Career Research and Resources
Otsuka
Medical Writer, 12/98-5/99 * Wrote abstracts, manuscripts, protocols, SOPs, study reports, regulatory documents Senior Scientist IV, 5/96 - 12/98 * Pharmacology: developed two novel rodent models of aspirin-insensitive arterial thrombosis: tested anti-thrombin, anti-Xa, and anti-VIIa compounds for thrombosis * Developed rat models of intermittent claudication; Tested catheters to deliver drugs and growth factors locally, me...
Avg. Salary: $90,000 · Company Rank: Not Available
Texas Biotechnology
Project Manager * Insured FDA/GCP/ICH guidelines are followed * Monitor and report adverse events, review CRFs * Prepared INDs, NDAs, amendments, supplements, manuscripts, abstracts, study reports * Coordinated project implementation and management * Initiated sites for clinical trials, evaluated site suitability * Prepare and follow project budgets and timelines, monitor progress * Recruit...
Avg. Salary: $90,000 · Company Rank: Not Available
Glaxo
Research Scientist, Department of Pharmacology (promoted from Senior Scientist, 1989) * Basic research of the microvascular complications of diabetes and tested * drugs to reduce insulin resistance (euglycemic glucose clamp studies in rats) * Monitored renal function in diabetic rats (immunoassay for urine protein) * Tested vasoactive drugs on the microcirculation (muscle, brain, connective tissue, kidney) * Drug discovery ...
Avg. Salary: $90,000 · Company Rank: Not Available
The University of Iowa Hygenic laboratory
General laboratory maintenance and machine calibration. Cultured organisms, and perforemd microbiological testing.
Avg. Salary: $55,000 · Company Rank: Not Available
Jones Microbiology Institute
General laboratory maintenance and machine calibration. Inventory management, recording stock and organizing/managing laboratory materials according to ICH GCP requirements and FDA regulations.
Avg. Salary: $55,000 · Company Rank: Not Available
Cognitive Drug Research
Responsible for performing internal procedural audits to ensure compliance with companies quality management system and adherence to ICH GCP and FDA CFR 21. Updated SOP's and organizational procedures, to ensure current practices were being performed.
Avg. Salary: $55,000 · Company Rank: Not Available
Perceptive Informatics, PAREXEL International
Communicate with project managers and software engineers to ensure client deliverables are managed on-time and according to project requirments and specific implemented deadlines. Also responsible for project validation, live study support, and ensuring all work is done according to company procedure and FDA CFR 21.
Avg. Salary: $55,000 · Company Rank: Not Available
VantageLinks
Identify strategic opportunities to align skills with market needs. Hire staff, motivate and train employees to achieve 7 figure revenue while sustaining business in a down economy.
Avg. Salary: $135,000 · Company Rank: Not Available
Institute for Quality Resource Management
Provide new product commercialization solutions to clients by performing tasks of filing FDA submission, obtain reimbursement, train sales force, provide solutions for European companies selling in the U.S. Provide new product development guidance relative to finding best manufacturing opporutniites, proving proof of concept, guiding engineers with product prototype, assess market readiness for the new product, launch produ...
Avg. Salary: $135,000 · Company Rank: Not Available
Zimmer, Inc
Provide guidance and solutions for Zimmer products as they related to reimbursement for surgeons and hospitals. Achieved new ICD-9 and DRG codes in support of their reconstruction prodcuts. Provided due diligence on new company acquisitions reporting to the CEO of the company. Launched new surgical procedure which improved outcome for a select group of patients and achieved significant improvement in revenue for the surgeon...
Avg. Salary: $135,000 · Company Rank: Not Available
