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Online Resumes with "Clinical Regulatory"
Senior Clinical & Regulatory Dtr./VP with over 20 years experience in all phases of product development.
Over 20 years of experience working in industry in biopharmaceuticals, and Class II-III medical device development. Perform hands-on management of Clinical Operations, and Regulatory Affairs. Oversee cross-functional product development teams and implement systematic project management techniques for clinical trials to ensure alignment with overall product development timelines and market release. Instill continuous quali...
Tags for this Online Resume: clinical research, project management, regualtory, medical device, cllinical trials operations, clinical development, research, IDE, 510(k), CE, PMA, BLA, NDA
Medical & Patient Safety
A key role as an individual and/or team contributor in medical, clinical, regulatory, and preventative activities within evolving worldwide pharmaceutical and bio-technical platforms. Cultivate strong collaborative alliances; employing diplomacy in conflicting divergence, training, and influencing consensus. Resolve obstacles to positively impact both medical and business outcomes.
Tags for this Online Resume: Drug Safety, Pharmacovigilance, Medical Safety, Patient Safety, Medical Affairs
Regulatory Affairs Professional
I'm a clinical regulatory affairs professional with experience in taking medical device products to market in different countries. My experience includes all phases, including study design, budgeting and timeline development, medical writing (e.g., clinical protocol, IND, IDE, etc), clinical study initiation and oversight, data management, premarket notifications (e.g., 510(k), BLA, etc), clinical study reports, and direct ...
Tags for this Online Resume: FDA, ISO, submissions, 510(k), BLA, regulatory strategy, medical writing, management, medical devices
Manager, Regulatory Affairs
Clinical Regulatory Affairs
Clinical Regulatory Affairs
Executive Pharmaceutical Sales Professional
Tags for this Online Resume: Pharmaceutical, Medical device
Agricultural Technician
Senior Associate Research Operations - 6 years Industry experience
I am a Life science professional with over 6 years of experience with data mining, interpretation/ writing and document formatting to regulatory guidelines and showcased timely completion of projects with cross functional teams.
Tags for this Online Resume: San Francisco, Clinical trial data management, non-clinical data management, competitive intelligence, Documentation, medical writing