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Found 37 Skills
Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2.
Draft privacy policies, terms of service, disclaimers, and legal notices. Creates GDPR-compliant texts, cookie policies, and data processing agreements. Use PROACTIVELY for legal documentation, compliance texts, or regulatory requirements.
When the user wants to optimize pharmacy supply chain operations, manage medication distribution, ensure pharmaceutical compliance, or handle controlled substances. Also use when the user mentions "pharmacy logistics," "drug distribution," "controlled substances," "340B program," "formulary management," "medication safety," "specialty pharmacy," "drug shortages," "DEA compliance," "pharmaceutical traceability," or "DSCSA compliance." For hospital materials management, see hospital-logistics. For clinical trial drugs, see clinical-trial-logistics.
Manage change control for validated computerized systems. Covers change request triage (emergency, standard, minor), impact assessment on validated state, revalidation scope determination, approval workflows, implementation tracking, and post-change verification. Use when a validated system requires a software upgrade, patch, or configuration change; when infrastructure changes affect validated systems; when a CAPA requires system modification; or when emergency changes need expedited approval and retrospective documentation.
Statute and regulation interpretation framework. Use when reading statutes, classifying requirements, analyzing operative keywords, applying canons of construction, or mapping compliance obligations from legislative text.
Search, purchase, and manage phone numbers with regulatory compliance and sender assignment.
Produce a proposed marked-up policy redraft that closes a gap found by /regulatory-legal:gaps or /regulatory-legal:policy-diff. A first draft for internal review — not for direct application to approved policy documents. Use when the user says "redraft the policy", "draft the policy fix", "mark up the policy", or when gap-surfacer hands off a gap for drafting.
Open gaps tracker — what's flagged and not yet closed. Use when the user asks "what gaps are open", "gap tracker", "remediation status", or wants to close (--close GAP-ID) or risk-accept (--accept GAP-ID) a tracked gap.
Legal and compliance expertise for corporate governance, contract analysis, regulatory compliance (SOX, GDPR, HIPAA), risk assessment, intellectual property, and litigation management. Use when reviewing contracts, ensuring compliance, or managing legal risk.
Design and implement end-to-end client onboarding workflows from prospect intake through funded account, covering KYC verification, document collection, e-signature, and custodian submission. Use when the user asks about building a digital onboarding flow, integrating identity verification or CIP checks, reducing NIGO rejection rates, opening complex account types like trusts or entities, connecting to custodian APIs, designing suitability questionnaires, or comparing advisor-assisted vs self-service models. Also trigger when users mention 'new account opening', 'onboarding bottleneck', 'KYC integration', 'beneficial ownership', 'OFAC screening', 'account funding', or 'onboarding automation'.
Assess IT vendors and third-party partners with multi-factor risk scoring and regulatory compliance checklists. Use when evaluating technology vendors.
Guides pension and retirement fund work—DB vs DC structures, funding policy, liability measurement (PV of benefits, discount rates, mortality), ALM overview, plan design, public and multi-employer pensions, risk transfer (buyouts, annuities, de-risking), US regulatory overview (ERISA, PBGC, DOL, IRS qualified plans), institutional investor role, and fiduciary governance—not legal or tax advice. Use when the user mentions pension fund, retirement plan, defined benefit, defined contribution, 401(k), pension funding, PBGC, ERISA, pension liability, discount rate pension, pension buyout, de-risking pension, or ALM pension—not P&C insurance (property-casualty-insurance), actuarial modeling only (actuary), actuarial engagements (actuarial-consulting), personal IRA advice (financial-analyst), or legal interpretation (commercial-counsel).