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Regulatory Affairs Associate I - Proofreading - Parsipanny NJ

Date: Apr 25, 2019

Location: Parsippany, New Jersey, US, 07054

Company: Teva Pharmaceuticals

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!

RA Associate I, Proofreading Job Description

The Associate Proofreader position is a seasoned proofreading position responsible for reviewing pharmaceutical package component labeling artwork for accuracy in accordance with  the Artwork Management System Instructions, Regulatory Affairs Labeling draft,  FDA CFR Labeling Regulations and Teva Graphic Standards. The incumbent will complete reviews using a combination of electronic proofreading systems and manual reading. The incumbent will be familiar with artwork workflows and, in particular, those workflows associated with pharmaceutical labeling and able to follow these workflows to ensure all steps are successfully completed in the function of this role. The incumbent will initiate proper workflows within the AMT artwork management system to gain additional approvals. Following the completion of all external reviews, the incumbent will initiate an additional workflow to forward the project to the AMT Graphics Group. The incumbent shall effectively manage and prioritize all projects to ensure that work is complete in accordance with target dates for FDA submission and / or production dates. Proactively provide assistance to others in completing tasks as necessary.  The incumbent shall demonstrate an enhanced ability to proactively detect contend and format errors/inconsistencies in pharmaceutical labeling documents (including cartons, labels, patient and prescribing information) by applying existing knowledge of regulations and guidance. The incumbent shall demonstrate an enhanced ability to proactively detect contend and format errors/inconsistencies in pharmaceutical labeling documents (including cartons, labels, patient and prescribing information) by applying existing knowledge of regulations and guidances. Manage the proofreading of third-party artworks, the proxy approvals for technical review and the uploading into the AMT artwork management system of all required documentation.

Qualifications

BA / BS degree or equivalent experience. Minimum 4 years pharmaceutical labeling experience and experience with electronic proofreading software. Electronic TVT and or Global Vision Digital Page experience. Possess a strong knowledge of electronic proofreading applications and proofreading best practices. Proficient with electronic proofreading applications, MS Office, Adobe Acrobat Professional, and labeling project tracking system.

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

In process of validation

Teva’s 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.


Nearest Major Market: New York City
Nearest Secondary Market: Newark

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