What are the responsibilities and job description for the Manager 1 - Regulatory Compliance position at Pioneer Data Systems?
Position Details:
Our client, a world-leading Pharmaceutical Company in Irvine, CA is currently looking for an Regulatory Affairs Specialist (MLR Review) to join their expanding team.
Job Title: Regulatory Affairs Specialist (MLR Review) / Pharma Industry / REMOTE WORK
Duration: 10 months contract, extendable up to 24 months
Location: Remote Worker
Client Location: Irvine, CA
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
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
Our client, a world-leading Pharmaceutical Company in Irvine, CA is currently looking for an Regulatory Affairs Specialist (MLR Review) to join their expanding team.
Job Title: Regulatory Affairs Specialist (MLR Review) / Pharma Industry / REMOTE WORK
Duration: 10 months contract, extendable up to 24 months
Location: Remote Worker
Client Location: Irvine, CA
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
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
