The Kick-off Meeting Checklist

Who should use this

• Heads of Regulatory Affairs accountable for timelines, budget and governance
• Medical Writing Managers setting projects up to run smoothly
• CMOs and senior clinical leaders who absorb the cost when kick-offs go wrong
• Anyone commissioning CSRs, manuscripts, RWE reports or CTDAPs

What you will be able to do

➤ Know exactly what must be decided by the end of the meeting
➤ Confirm roles and decision authority from the start
➤ Lock review windows to calendar dates, not vague durations
➤ Agree what’s in scope (and what’s out) before drafting begins
➤ Surface project risks early, while they’re still cheap to fix
➤ Leave with Draft 1 aligned

Overview

Too often the kick-off meeting is treated as a formality. That false alignment unravels slowly and expensively across the project. This checklist makes the kick-off do its real job: catching the decisions, roles and risks that quietly derail projects later.

What is covered

1. Pre-KOM prep: everything to confirm before you walk in
2. The KOM agenda: roles, scope, data, timelines and risks, in order
3. The 20-question readiness check: strategy, decisions, scope, data, timelines, risk
4. Post-KOM outputs: the summary and trackers that hold decisions in place

Jane Loh

Epidemiologist and regulatory medical writer with an MSc in Population & Public Health. She works end-to-end on clinical programmes with complex data and small populations, from study design and data interpretation to publication-ready writing.

Rose Gallay-Menil

Business Development Lead at Azur Health Science., Rose connects pharma, biotech and CRO partners with the medical writing and consulting expertise they need, building long-term partnerships across Europe and international markets.

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