Manager / Sr. Manager Clinical Development
Date: Jan 6, 2021
Location: Sao Paulo, BR, 04576
Company: Teva Pharmaceuticals
Company Info
Job Description
· Responsible for the clinical requirements to register new generic products for Brazil market;
· Review methods and manage Pharmaceutical Equivalence (PE) studies at contracted CROs;
· Review clinical strategies and generate biowaivers where possible;
· Evaluate Bioequivalence (BE) study designs, then plan and manage studies at contracted CROs;
· Source Reference standards and products and organize shipment to PE/BE CROs;
· Respond to deficiencies from ANVISA and participate in PE/BE scientific advice meetings with the agency;
· Support the above activities as necessary for other LATAM markets (Argentina, Chile) when required.
Qualifications
· Degree in pharmacy or another degree in natural sciences;
· Fluent in English and Portuguese. Spanish is an asset
· Knowledge in Clinical Development (GCP, GLP, regulatory requirements);
· 3-10 years of experience in the pharmaceutical industry or CRO background;
· Experience in generic medicine projects and studies design;
· Soft Skills: ability to communicate, team-oriented, responsible, collaborative workstyle and proactive.
Function
Sub Function
Reports To
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