author-applicants-position

# Applicant's Position Authoring Draft and review the clinical pharmacology applicant's-position sections of a regulatory briefing package. Each position is stated as a claim with its scope, the evidence that supports it, the pre-specified rule it rests on, its stated limitations, and its residual gaps — structured so that every position is auditable against the cited evidence and no position reads as agreed, accepted, or endorsed by the skill. **This skill drafts and reviews positions. It never commits, never asserts that a position is agreed, never predicts what an agency will decide, and never states a commitment the regulatory owner has not approved.** ## Who this is for Clinical pharmacology leads drafting applicant positions for a Type A, B, or C meeting · CP reviewers stress-testing positions before internal review · regulatory strategy partners checking that every CP position is evidence-backed. ## When to use this skill - "Draft the applicant's positions for the CP section of the pre-NDA briefing" - "Stress-test our dose-selection position against the cited evidence" - "Check that every position in this draft is actually supported by an annex" - "Review the applicant's positions for the Type B meeting" - "Is any position contradicting what we stated last time?" ## When NOT to use this skill | Request | Why not this skill | Where it belongs | |---|---|---| | "Draft the questions we should ask the agency" | Question-set design, not position authoring | `prepare...