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Job #02488

About our client Our client is a specialty generic pharmaceutical company engaged in the formulation and commercialization of both controlled release ("CR") and immediate release ("IR") products utilizing proprietary drug delivery technologies. By applying the technologies to selected generic prescription pharmaceuticals, the company seeks to duplicate the release characteristics of these drugs in order to manufacture and market versions that can be substituted for branded products. It intends to develop and use their drug delivery technologies to commercialize a portfolio of generic pharmaceutical products. In the near future, they also plan to apply drug delivery technologies to the development of proprietary branded drugs. Position Location Clinical Research Associate Florida Salary Highly competitive package, commensurate with experience Responsibilities 1) Identify and oversee CROs, consultants, and other related 3rd party entities 2) Coordinate all necessary activities, including protocols, set ups, monitoring and reporting of bio studies in support of ANDAs 3) Ensure all bio studies are conducted in accordance with applicable regulatory guidelines 4) Discuss study design and results with team members 5) Perform clinical monitoring Requirements 1) MS or BS degree in Clinical or Biological Science 2) Minimum 2 years of CRA monitoring experience 3) 1-2 years of experience in drug development, bio-pharmaceutics, clinical monitoring, regulatory affairs, etc. 4) Experience in conducting bioequivalence studies 5) Experience in solid dosage forms highly preferred 6) Experience in semi-solids and liquids a plus 7) Knowledge of MS Word, Excel, medical/regulatory terminology 8) Excellent written and verbal communication skills 9) Excellent project management skills 10) Ability to travel – up to 10%