1+ months

Clinical Research Studies - Clinical Regulatory Affairs Associate

Miramar, FL 33025
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

The Regulatory Affairs Specialist is responsible for establishing, maintaining, and providing administrative management of the Regulatory Documents in accordance with federal regulations, ICH Guidelines, good Clinical Practices (GCPs) and WTI Standard Operating Procedures (SOPs). 

Conducts all regulatory activities in accordance with Institutional Review Board (IRB) guidelines, Good Documentation Practices (GDPs), Good Clinical Practice (GCP) standards, Standard Operating Procedures (SOP's), Quality procedures (QA/QC), OSHA guidelines and other state and local regulations as applicable, ensuring strict compliance to the study protocol at all times

Generates, facilitates and maintains all study related regulatory documents from prestudy through study close out, ensuring quality, accuracy, and timeliness

Maintains regulatory documents according to GCP, ICH, FDA, and Sponsor requirements

Prepares and maintains records for archiving and/or retrieval

Reviews all regulatory documents prior to Sponsor/Monitor/ Regulatory Authority visits.

Works with Clinical Study Managers, clinical staff, IRB, and study Sponsors to resolve site and study related Regulatory concerns issues

Provides administrative and operational support to internal departments and clinical management teams

Qualifications

Education:  a Bachelor's Degree in a health field is required.

Experience organizing documents, Trial Master File preferred, in a health environment.

Minimum of three (3) years of experience in the pharmaceutical industry, supporting clinical study conduct in an operational or training capacity and/or experience in a medically related profession, pharmaceutical, medical device company, or as a clinical research coordinator at an investigative site.

An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

Certification/Licensure CCRC preferred

Possesses an understanding of medical terminology and the application of scientific/medical and clinical concepts to conduct clinical trials

Possesses an understanding of the CFR and ICH Guidelines as they pertain to required study documents

Possesses strong organizational and time management skills

Excellent interpersonal, organizational, and time-management skills

Able to work under extremely tight deadlines

Strong analytical and decision making skills

Able to coordinate workloads to meet extremely tight deadlines

Proficient in MS Office Suite (Word, Excel, Outlook, PowerPoint), knowledge of MS Project, database and project management software desired

Physical Requirements and Working Conditions: Incumbents in this class are subject to extended periods of sitting, standing, walking, stooping, bending, and lifting materials and supplies weighing up to 25 pounds.

Function
Regulatory Affairs
Sub Function
Medical Regulatory Affairs
Reports To

Manager,  Regulatory Affairs

Already Working @TEVA?

The descriptors are broad global definitions based on Towers Watson grade and career path language.  The descriptors are not specific position descriptions and are intended to be used for reference purposes only.

If you have comments or suggestions for improvements we would very much like to hear from you!  Please contact us at Globalcareerarchitecture.Tevaglobal@teva.co.il.

Tevas Equal Employment Opportunity Commitment
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.

Categories

Posted: 2019-07-01 Expires: 2019-09-14

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Clinical Research Studies - Clinical Regulatory Affairs Associate

Teva Pharmaceuticals
Miramar, FL 33025

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