Scientific Content MLR Process

Unified workflow for all external communications

1
Strategy Development & Endorsement
Develop comprehensive strategy, objectives, and target audiences. Determine document ownership and compliance requirements.
GxP vs Non-GxP Classification
📋
NDA Materials
Confidential content
📢
External Comms
Public communications
📚
Publications
Scientific manuscripts
2
Planning & Author Engagement
Identify content owners, co-authors, timelines, and required resources. Engage external authors per ICMJE guidelines.
Publication type requires SciWind notification?
Timeline Planning Resource Allocation Author Identification
3
Content Development
Draft content with input from content team, including co-authors and biostatistics validation.
Content Owner
Lead Development
Co-Authors
Scientific Input
Biostats
Data Validation
4
Internal Content Review
Ensure alignment with key messages, lexicon consistency, and scientific accuracy before MLR submission.
Message Alignment Scientific Accuracy Content Optimization
5
MLR Review (Parallel Process)
Simultaneous Medical, Legal, and Regulatory review with consolidated feedback and revision cycles.
Medical
Scientific Accuracy
Legal
Compliance & IP
Regulatory
FDA/EMA Standards
Review Timeline Based on Content Type
Abstracts: 5 days Manuscripts: 10 days External Comms: 3 days NDA Materials: 3 days
6
Final Review & Approval Decision
Critical decision point - all issues must be resolved
✓ APPROVE
Proceed to Release
↻ REVISE
Return for Changes
7
Release, Submit & Archive
Final processing, DocuSign approval, and archive to appropriate systems including SciWind for publications.
Publication requires SciWind archive?
PDF Conversion DocuSign Archive SciWind (Pubs)
Process Legend
Sequential Process Steps
Parallel Review Activities
Decision Points
Approval Gates
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