Impact & Deliverables
Situation: Early-stage pharma teams needed documented governance frameworks covering SOPs, operational templates, and regulatory readiness. Required structure for future SEC filings and compliance reviews.
What I built: Modular policy framework with department-spanning policies (HR, IT, Legal, Finance, QA) and operational templates for early-stage life-science teams. Structured documentation covering data governance, vendor management, employee protocols, and regulatory compliance standards.
Outcome: Complete policy foundation positioned for SEC filings and investor diligence. Organized as modular documentation with implementation guidance and regulatory reference mapping.
Consulting Relevance
Policy Framework Development Process
Modular governance documentation built for operational clarity and regulatory compliance.
Scope & Structure
Department coverage
Clinical operations, HR, IT, Legal, Finance, QA, and Vendor Management. Framework designed to scale with organizational growth.
Document hierarchy
Core policies linked to departmental SOPs, worksteps, forms, templates, training materials, and audit tools. Modular structure supports rapid customization.
Version control
Document ownership assignments, version identifiers, effective dates, revision logs, and distribution protocols for audit trail maintenance.
Objectives
Standardize onboarding and operational procedures while establishing audit readiness and cross-functional alignment.
Standards & Quality Control
Documentation Standards
Header standards
Consistent naming conventions and header elements: Purpose, Scope, Definitions, Roles, Document Owner, Effective Date, Revision Number, and Cross-References.
Content structure
Policy statement followed by procedural steps with role assignments, record-keeping requirements, training specifications, and compliance notes. Cross-departmental workflow links included.
Terminology management
Shared glossary and tagging system maintaining consistent language across Clinical, HR, IT, Legal, Finance, QA, and Vendor documentation.
Review & Compliance
Cross-functional review
Structured review checkpoints with subject matter experts from affected departments. Readability and completeness validation applied.
Regulatory alignment
Purpose, scope, and record-keeping sections structured to meet standard audit expectations. Document control protocols ensure traceability.
Publication process
Final approval workflow, version stamping, and distribution guidance specifying intranet, training packet, or shared drive placement.
Deliverables & Implementation
Master library
100+ documents spanning all departments: core policy templates, SOPs, training outlines, and audit preparation tools. Structured for client-specific tailoring.
Training materials
Orientation guides, usage instructions, and department-specific starter packs designed to accelerate adoption.
Audit preparation
Vendor QA checklists, data privacy policy templates, and regulatory readiness checklists for partner and compliance reviews.
Maintenance framework
Organized folder structure with document identifiers and recommended monthly or quarterly review cycles. Domain-agnostic design adapts across industries.
Example policies
HR candidate evaluation protocols, clinical investigator responsibilities, budget and forecast procedures, data privacy and protection frameworks.
Confidentiality & Operations
Template library contains no client PHI or PII. Access restricted to authorized personnel with version control and backup protocols. Distribution limited to designated roles with optional watermarking. Periodic format and content refresh maintains library currency.