Manager / Sr. Manager Clinical Development

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

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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Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.