prepare-position-defence-brieflisted

# Representation and Position Defence Brief Representation and position defence — produce a source-linked finding register a qualified reviewer can act on. Every finding carries a locator, a severity, and a detection path. The register arrives open; only a named human may close an item. > **Skills review, reconcile, verify, structure and flag. Qualified humans > decide, approve, sign off, submit and act.** ## Who this is for Clinical pharmacology or pharmacometrics practitioners working in **Agency engagement** who need a bounded, repeatable review of this L3 task — not a decision, not a draft to submit, and not a substitute for the accountable human owner. ## When to use this skill - "Build the defence brief for our DDI waiver position" - "What evidence supports our flat-dosing position if the agency pushes back?" - "Assemble the counter-arguments for our renal impairment waiver" ## When NOT to use this skill These are close neighbours. Route them elsewhere and say so: | Request | Why not this skill | Where it belongs | |---|---|---| | Decide the position | A strategic decision | Qualified reviewer and programme leadership | | Draft the agency response | Outward-facing document | Regulatory affairs under human control | | Predict what the agency will accept | Speculation | Out of scope | ## Required inputs Ask for these by artifact, not by category. If one is missing, say which check it disables rather than proceeding silently. | # | Input | Form | Role | |---|--