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Anlage Infotech
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Submission Specialist

Submission Specialist

Anlage Infotech

3 - 8 years

4 - 7 Lacs

bangalore rural bengaluru

Posted:16 hours ago| Platform:

Apply

Skills Required

submission regulatory affairs fuse regulatory guidelines fda publishing medical writing regulatory publishing veeva ectd regulatory submissions

Work Mode

Work from Office

Job Type

Full Time

Job Description

This is an exciting role and would entail you to

• Oversee the end-to-end submission process of materials to the MLR review platform (Veeva Vault Promo Mats)

• Understand and document client-mandated submission requirements and ensure these protocols are maintained with guidance from MLR/Submission managers

• Create, uphold, and maintain submission checklists for assigned brands and ensure accurate and timely MLR submissions into Client systems

• Maintain a comprehensive and accurate record of all current and upcoming submissions including the stage of review, job codes, references, and deadlines

• Annotate any notes/comments relevant to MLR reviewers onto the submission file (As required, for identifying derivative/pick-up content, or callouts for changes between reviews)

• Perform QC of MLR submission components/package prepared by the team, before submission, and prepare and submit electronic and/or paper MLR-submission, including electronic tagging and linking references in Client system

• Establish and build relationships with all internal cross-functional team members in collaboration with the Copy department, organize references to streamline project submissions

• Support cross-functional team with opening projects in Client review platforms in collaboration with the Editorial team

• Proofread/fact check against multiple source documents to confirm annotation accuracy

• Stay current with new electronic submission and regulatory documentation practices and standards

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Anlage Infotech

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Submission Specialist