Scientist (pharmacokinetics) at Perrigo API India Pvt Ltd Perrigo API India Pvt Ltd - Mumbai,.."R"

Scientist (pharmacokinetics) at Perrigo API India Pvt Ltd
Perrigo API India Pvt Ltd - Mumbai, Maharashtra

Job Specifications: 1. Expertise in Pharmacokinetics / Bio-pharmaceutics in academic research or generic pharmaceutical company or contract research organization 2. Hands-on experience in independently designing pharmacokinetic studies for ANDAs (and possibly NDA submissions), reviewing bio-analytical protocols / reports, analyzing pharmacokinetic data, and proposing PK strategies from a quality-by-design (QbD) perspective 3. Awareness of FDA (US, India) and EMEA guidelines on clinical studies and its conduct 4. Good grasp of statistical methodology required in clinical sciences 5. Demonstrated ability to work independently, manage and prioritize multiple projects, and perform concertedly in a team environment 6. Exhibits a sense of urgency, ownership, and drive. Demonstrates excellent interpersonal, written and verbal communication skills, and ability to prepare written reports / correspondence and presentations to senior leadership. 7. Ability to work closely with Product Development scientists (India, US, UK, Israel, and other sites) by performing as one of the technical leads in bio-pharmaceutics. The incumbent will also act as an advisor in clinical drug development, CRO outsourcing, study monitoring, project management, and make sure that that study conduct is in compliance with regulatory requirements. About 10% of business travel should be expected.CLICK HERE TO APPLY