Regulatory Specialist

September 17

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Brand Services • Photography • 3D & CGI • Print & Packaging • TV Post Production

1001 - 5000

💰 Venture Round on 2008-01

Description

• * Checks quality and accuracy of annotations, tags/links, reference binders/packs, and edits to all advertising, promotional, and non-promotional communication materials to ensure accuracy of text, layout, organization and references; compliance with AMA or AP guidelines; and overall sense, consistency, and clarity. • * Work closely with Medical Editors/Medical Copy Editors and Production team & other stake holders to ensure that jobs are compliant to brand, style, and file standards. • * Keep submission schedule on track during the transition from medical editing (upload) to submission. • * Ensure completed job by the studio meets the exact file standards and brief provided, and completing the jobs as per the planned timelines. • Help Project Management and Production teams to ensure that all files coming in are of suitable quality and align with file and brand standards at the start. • Constant communication with MLR, Production, and Project Management teams.

Requirements

• * Hands of experience on Veeva Vault PromoMats is mandatory. • * Must be aware of different types of submissions involved in content approval by clients/regulatory bodies/healthcare authorities preferably the US and UK. Knowledge on the submission process in other regions including EU, middle east & Asian markets is a plus.