RA Associate, AMT Proofreading

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!

Teva’s Global Research & Development (R&D) organization is devoted to the development of new medicines, devices and combination products that provide meaningful therapeutic benefit to patients worldwide. Combining creativity, scientific rigor and our extensive knowledge on a broad range of technologies, our scientists, engineers, medical doctors and project leaders across the globe use their expertise to innovate novel biologics, biosimilars, small molecule specialty medicines, generics and over-the-counter therapies.

Teva offers a competitive benefits package including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee Stock Purchase Plan and Tuition Assistance. For more information on Teva, check us out at www.tevapharm.com or www.tevausa.com

Job Description

The Associate I Proofreader position is an entry-level 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 general artwork workflows 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 all projects to ensure that work is complete in accordance with target dates for FDA submission and/or production dates.

The incumbent shall demonstrate an enhanced ability to proactively detect content and format errors/inconsistencies in assigned documents.

Must be capable of suggesting enhanced proofreading standards to ensure the most effective methods of detecting errors.

Core Duties and Responsibilities
With relevant oversight, utilizing the electronic proofreading systems, review labeling artwork files for compliance with Teva Graphic Standards, instructions and Regulatory Affairs Labeling draft. Manually review labeling artwork to ensure dimensional accuracy and format of labeling content. Verify the correctness of all barcodes and scan to verify acceptable GS1 grades. Document proofreading activities on the appropriate check list and upload into the AMT artwork management system. Initiate routing of labeling artwork for external approvals within the AMT artwork management system and via email.

With guidance, prioritize work, interact and collaborate with other AMT colleagues, Regulatory Affairs, Package Engineering, Packaging sites, and external component suppliers, respond to and resolve issues as directed to meet established schedules.

With minimal supervision, manage the proofreading of third-party artworks, the proxy approvals for technical review, vendor proof review and uploading into the AMT artwork management system of all required documentation.

Responsible for ensuring compliance with current Federal Regulations and guidelines on labeling, Teva labeling guidelines and standards for format, and all AMT SOPs and Work Instructions.

Qualifications

What you will bring to the role (minimum requirements)
Associate's degree
Minimum 2 years of proofreading experience

Preferred Requirements
BA / BS degree
Pharmaceutical labeling proofreading experience with Electronic Proofreading Systems

Function

Sub Function

Reports To

Manager RA, Proofreading Regulatory Affairs US Artwork Management Team

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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.

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Teva Pharmaceuticals USA requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, however, Teva will consider requests for reasonable accommodations.