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HEMA Biologics · 13 hours ago

Legal & Compliance Operations Specialist

Louisville, KY, US

Full-time

Onsite

Entry, Mid Level

2+ years exp

HEMA Biologics is a company focused on legal and compliance operations, and they are seeking a Legal & Compliance Operations Specialist. This role supports the Legal and Compliance teams by managing operational, administrative, and systems-related needs, including contracting lifecycle management and compliance activities.

BiopharmaBiotechnology

Responsibilities

Provide broad operational and administrative support for Legal matters, including coordination of legal requests, document organization, and maintaining departmental files and records

Assist with contract workflow administration, including intake triage, CLM workflows, signature processes, and management of templates and clause libraries

Maintain organized, accessible storage for contracts, policies, IP documents, and other legal records

Support IP administration, including docketing, renewals, and coordinating with outside counsel as needed

Assist with litigation, pre-litigation, and dispute resolution matters, including maintaining litigation calendars, deadlines, and correspondence logs, and supporting outside counsel with document production and administrative needs

Provide general support across Compliance Program activities, including policy and procedure maintenance, training coordination, documentation, and tracking

Assist with compliance investigations intake, issue tracking, follow-up documentation, and reporting

Conduct data collection and administrative support for transparency reporting (e.g., Open Payments, state reporting)

Maintain accurate compliance records and help ensure documentation is audit-ready

Collaborate with Finance, Procurement, Marketing, Sales, Medical Affairs, Regulatory, IT, HR, and other stakeholders to support Legal & Compliance processes and requests

Assist with dashboards, metrics, and reporting related to Legal and Compliance workflows

Help coordinate departmental projects, process improvements, SOP updates, and internal initiatives

Support periodic Compliance auditing and monitoring activities, including data pulls, sampling, process walk-throughs, and documentation reviews

Track findings, remediation steps, and follow-up items

Contribute to continuous improvement of monitoring tools, checklists, and internal controls

Qualification

Legal operationsCompliance operationsContract managementCLM systemsDocument management systemsMicrosoft 365Record-keeping skillsDiscretionOrganization skillsCommunication skillsConfidentiality