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Job Requirements of Regulatory Compliance Lead:
-
Employment Type:
Contractor
-
Location:
Irvine, CA (Onsite)
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Regulatory Compliance Lead
Careers Integrated Resources Inc
Irvine, CA (Onsite)
Contractor
Fully Remote
Regulatory Compliance Lead:
Job Description: Operates as primary content approval contact for Global Sales Education/ Professional Education/ US Marketing. Prepares documents for VEEVA submissions; annotating and cross checking references, tagging/linking/loading all related documents into the system. Serve as the liaison between the reviewers and content developers/SMEs to reach editorial solutions Immersion in relevant project claims matrices and references to become a Subject Matter Expert (SME) to proficiently and proactively navigate reviewer comments and make content recommendations that remedy compliance issues, if and when possible Ensures that all submissions accurately and consistently capture MLR comments and follow submissions through to approval. Create an internal tracking process that captures the current status of all projects routing for compliance review. Troubleshoots and guides submission workflow in challenging situations, supporting submission approval. Meets with reviewers to develop relationships, build rapport, and influence without authority. Develops best practices for content submission within Global Sales Education/ Professional Education/ US Marketing.
Top Three Skills: Veeva, Medical, legal, and regulatory (MLR) experience, regulatory process and deliverables, project management
3-5 years exp
Regulatory Compliance Lead:
Job Description: Operates as primary content approval contact for Global Sales Education/ Professional Education/ US Marketing. Prepares documents for VEEVA submissions; annotating and cross checking references, tagging/linking/loading all related documents into the system. Serve as the liaison between the reviewers and content developers/SMEs to reach editorial solutions Immersion in relevant project claims matrices and references to become a Subject Matter Expert (SME) to proficiently and proactively navigate reviewer comments and make content recommendations that remedy compliance issues, if and when possible Ensures that all submissions accurately and consistently capture MLR comments and follow submissions through to approval. Create an internal tracking process that captures the current status of all projects routing for compliance review. Troubleshoots and guides submission workflow in challenging situations, supporting submission approval. Meets with reviewers to develop relationships, build rapport, and influence without authority. Develops best practices for content submission within Global Sales Education/ Professional Education/ US Marketing.
Top Three Skills: Veeva, Medical, legal, and regulatory (MLR) experience, regulatory process and deliverables, project management
3-5 years exp
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