author-applicants-positionlisted

Drafts and reviews the clinical pharmacology applicant's-position sections of a regulatory briefing package — each position stated as a claim with its scope, the evidence that supports it, the pre-specified rule it rests on, its limitations, and its residual gaps — structured so that every position is auditable against the cited evidence and no position reads as agreed or accepted. Use this skill when someone asks to draft or review applicant's positions for a regulatory interaction, stress-test positions against their evidence, or check that every position is supported. Example: "Please to draft or review applicant's positions for a regulatory interaction, stress-test positions against their evidence." Do not use for the meeting-request letter itself, for responding to questions an agency already sent, for CTD summary content, for the question-set design, or for any request to assert that a position is agreed or will be accepted.
malekokour/clinpharm-pmx-skills · ★ 6 · API & Backend · score 77

Install: claude install-skill malekokour/clinpharm-pmx-skills

# 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