Pharmaceutical labeling specialist (Austell, GA)

Pharmaceutical labeling specialist

s www.globalchannelmanagement.com jobopeningsjobs(at)globalchannelmanagement.co mPharmaceutical labeling specialist needs 2 years of pharmaceutical labeling experiencePharmaceutical labeling specialist requires scientific background or familiarity with medical terminology. Artwork and SPL experience is required. Proficient in standard computer programs such as Microsoft Office Excel Word Outlook and Sharepoint. Food and Drug Administration (FDA) regulations and guidelines. Current FDA Regulatory Affairs submission requirements. Logistics and work of the pharmaceutical industry. Current Company policies practices and procedures including safety rules and regulations Pharmaceutical labeling specialist duties responsible for the preparation of high-quality labeling documents for submission to the US Food and Drug Administration (FDA). Labeling documents include those prepared for FDA submissions Annual Reports and PSURs in compliance with regulatory requirements and within company timelines. Assist labeling managers with overall labeling process of brand prescription products Proofread package insert as well as packaging components. Prepare redline documents and comparison charts Understand working in a digital workflow system and using online proofreading tools