Labeling Proofreader (Remote)

Actalent
Remote in Orlando, FL Full Time
POSTED ON 5/10/2022 CLOSED ON 5/21/2022

What are the responsibilities and job description for the Labeling Proofreader (Remote) position at Actalent?

Equivalent Experience

This leading multi national pharmaceutical is looking to take on a 100% remote Consumer and Rx Proofreader onto their team - Apply now!

Must Have:
  • Pharmaceutical background
  • Labeling experience for FDA approved drugs
  • Proficient in Microsoft (advanced), Excel, Adobe
  • Drug listing and Dailymed
  • Proofing Software
  • Copy editing
Assist labeling leads with proofreading of artwork for new and revised Rx labeling in accordance to FDA current guidelines and regulations.

Prepare and submit product drug listings and SPL (Structured product labeling) files to the FDAs ESG (Electronic Submissions Gateway) via i4i or outsourced as per supervisor direction.

Independently or together with key supervisor and stakeholders carry out all assigned activities.

Review in ELM artwork management system.

Additional Skills & Qualifications:Experience needed:
  • Pharmaceutical
  • 4-6 years experience
  • Redlining
  • Strong Regulatory labeling Operations experience including an understanding of CFR labeling requirements as they apply to Rx, Generic and device products
  • Understanding of pharmaceutical business functions that impact labeling such as supply chain
  • Excellent organizational skills a must
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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