Areas of Practice
Medical Communications
Scientific Platform / Scientific Narrative
• Outlining your product’s core scientific story while ensuring consistency across all communications (medical, commercial, regulatory).
Core Claims Document
• Listing approved and supported claims about the product (efficacy, safety, MOA).
• Claims with links to specific evidence from clinical trials or publications.
Global Medical Affairs Plan (GMAP)
• Outlining medical communication objectives and tactics across the lifecycle.
Healthcare Professional (HCP)-Facing Documents
Medical Information Responses / Letters
• Evidence-based, non-promotional responses to unsolicited HCP questions.
Slide Decks / Scientific Presentations
• For use by MSLs (Medical Science Liaisons) or at congresses and symposia.
Scientific Posters and Abstracts
• For use at scientific conferences to communicate clinical trial data and real-world evidence.
Peer-Reviewed Publications / Manuscripts
• Journal articles based on clinical trials, HEOR studies, or reviews.
• Publications Planning
• Targeted literature reviews, systematic literature reviews, and landscape assessments to support launches (global and local health technology assessment and portions of market access submissions)
• Development, editing and submission of scientific manuscripts, abstracts, posters and presentations in accordance with Good Publication Practices (GPP) and the Sunshine Act
Advisory Board Reports
• Summarizing insights from external HCPs and key opinion leaders (KOLs).
Clinical & Research-Based Documents
Clinical Study Synopses and Summaries
· Condensed versions of study protocols or results for internal and external use.
Investigator Brochures (IBs)
· Comprehensive product information provided to clinical trial investigators.
Plain Language Summaries (PLS)
· Summaries of clinical trial results written for a general audience or patients.
External Engagement and Training Materials
Medical Training Materials
· For training internal medical teams, including MSLs and medical directors.
FAQs and Messaging Guides
· Standard responses to common questions from HCPs and patients.
Congress Booth Materials
· Scientific information for presentation at professional conferences.
Compliance and Regulatory
Regulatory strategy
· Regulatory medical writing
o Clinical study protocols and amendments
o Labeling
o Clinical study reports (CSRs)
o Briefing documents
o Clinical sections of INDs, NDAs, BLAs, and other regulatory submissions
o Regulatory filings: Clinical sections of IND/CTAs, NDA/BLA/MAAs and other regulatory submissions
o Fast track designation, breakthrough therapy, and accelerated approval applications, PRIME assessment and conditional marketing authorization applications
Health authority interactions
Preclinical / Pre-Phase 1
Pre-IND (Investigational New Drug) Meeting (US FDA) / Scientific Advice (EMA, MHRA, etc.)
Purpose: Seek guidance on preclinical data, trial design, and regulatory expectations before submitting an IND/CTA.
Orphan Drug Designation (ODD) Applications
Pediatric Investigation Plan (PIP) or Pediatric Study Plan (PSP) submission
Phase 1 (First-in-Human Trials)
IND/CTA Submission and Approval
Required to begin clinical studies.
Clinical Trial Application (CTA) Amendments
For protocol changes or additional arms.
Safety Reporting
Serious adverse event (SAE) and suspected unexpected serious adverse reaction (SUSAR) notifications.
Type B Meetings (FDA) or Scientific Advice Follow-Up
For further clarification on early clinical data or Phase 2 plans.
Phase 2 (Dose Finding and Proof-of-Concept)
End of Phase 2 (EOP2) Meeting (FDA)
Critical checkpoint before Phase 3; discuss pivotal trial design, endpoints, patient population.
Scientific Advice / Protocol Assistance (EMA/other agencies)
Interactions on Special Designations
Fast Track, Breakthrough Therapy (FDA), PRIME (EMA), etc.
Risk Management Plan (RMP) Discussions (EU)
Phase 3 (Pivotal Trials for Approval)
Pre-NDA/BLA / Pre-MAA Meeting
Final alignment on data package and format before submission.
Rolling Review or Accelerated Pathways Discussions
If eligible (e.g., Priority Review, Accelerated Approval, Conditional Approval).
Label Negotiation Meetings
o Discussions on proposed indication, language, and safety info.
Advisory Committee Meetings (US) or CHMP Oral Explanations (EU)