Paralegal & Legal Operations Specialist

PAI Holdings LLC•Parsippany-Troy Hills, NJ

5h•$90,000 - $120,000

About The Position

The Paralegal & Legal Operations Specialist provides comprehensive legal, compliance, regulatory, and administrative support to the Legal Department of a pharmaceutical company. The role supports commercial contracting, litigation management, corporate governance, intellectual property, compliance initiatives, legal operations, budgeting, transparency reporting, and state licensing. It serves as a liaison among Legal, Compliance, Regulatory Affairs, Quality, Finance, Commercial, and external counsel to help ensure legal and regulatory obligations are met efficiently and effectively. The ideal candidate is highly organized, detail-oriented, proactive, and able to manage multiple priorities in a fast-paced, highly regulated pharmaceutical environment. The position reports to the General Counsel. The role involves frequent sitting, standing, walking, talking, and hearing; computer keyboard, monitor, and mouse use; and occasional reaching and lifting or carrying files and materials weighing up to 20 pounds. Near vision is necessary for computer monitor use. Reasonable accommodations may be provided to enable qualified individuals with disabilities to perform the essential duties. PAI Pharma is a nicotine-free campus, and nicotine products are prohibited on company property.

Requirements

Minimum of 5 years of paralegal, legal operations, compliance, or related legal support experience.
Strong understanding of legal procedures, contract administration, and corporate governance principles.
Working knowledge of regulatory compliance and state licensing requirements.
Excellent organizational and project management skills.
Strong written and verbal communication abilities.
Ability to manage multiple projects and deadlines simultaneously.
Strong analytical and problem-solving skills.
Proficiency with Microsoft Office Suite, including Word, Excel, PowerPoint, and Outlook.
Ability to handle confidential and sensitive information with discretion and professionalism.
Strong attention to detail and commitment to accuracy.
Integrity and professionalism, sound judgment and discretion, accountability, collaboration and teamwork, initiative and proactive problem-solving, and customer service orientation.

Nice To Haves

Bachelor's degree.
Paralegal Certificate from an ABA-approved or accredited program.
Experience supporting an in-house legal department.
Experience in the pharmaceutical, biotechnology, healthcare, or another highly regulated industry.
Experience with state licensing, regulatory compliance, or healthcare regulatory matters.
Experience with contract lifecycle management systems and legal matter management software.

Responsibilities

Draft, review, revise, and administer standard legal agreements, including confidentiality, consulting, vendor, and other commercial agreements.
Coordinate contract review and approval with internal stakeholders and outside counsel.
Maintain the contract lifecycle management system and legal document repository, and ensure executed agreements are properly archived and accessible.
Track contract expiration dates, renewal obligations, and notice requirements.
Assist attorneys with contract analysis, due diligence, and legal research.
Support litigation, arbitration, investigations, and other dispute resolution matters.
Manage legal holds and document preservation efforts.
Coordinate collection, review, and production of documents for litigation, subpoenas, audits, and regulatory requests.
Liaise with outside counsel on case administration and document management, and maintain litigation files, status reports, and tracking databases.
Maintain corporate records, filings, and governance documentation; assist with board and committee materials, resolutions, and written consents as needed.
Support corporate entity management, annual reports, secretary of state filings, and execution of corporate documents.
Assist with patent, trademark, copyright, and trade secret matters; maintain intellectual property databases and filing calendars; coordinate with outside intellectual property counsel; and track deadlines and renewals.
Support corporate compliance initiatives and legal compliance programs, including Open Payments and other transparency reporting.
Collect, validate, and organize compliance data; support monitoring, auditing, and investigations; coordinate training and maintain training records; and maintain policies, procedures, and compliance documentation.
Assist with preparation, submission, renewal, and maintenance of state licenses, registrations, permits, and regulatory filings across multiple jurisdictions.
Maintain licensing records, databases, and compliance calendars; coordinate with state regulatory agencies; monitor licensing requirements; and communicate impacts to stakeholders.
Support licensing and regulatory work related to new products, acquisitions, facility changes, and business expansion.
Assist with responses to regulatory inspections, audits, and agency requests; maintain supporting documentation; and escalate potential licensing compliance issues to Legal and Regulatory Affairs leadership.
Review, process, and track invoices from outside counsel and legal service providers; check compliance with billing guidelines and budgets; and coordinate approvals and payment processing.
Prepare legal spend reports, accruals, forecasts, and budget analyses, and assist with outside counsel and vendor relationships.
Manage Legal Department records and filing systems; schedule meetings; coordinate communications; prepare correspondence, presentations, reports, and legal documents; protect confidential information; and support special projects and other assigned duties.