Paralegal & Legal Operations Specialist
hace 7 días
Parsippany
Job Description Job Title: Paralegal & Legal Operations Specialist Department: Legal Reports To: General Counsel Job Summary: The Paralegal & Legal Operations Specialist provides comprehensive legal, compliance, regulatory, and administrative support to the Legal Department of a pharmaceutical company. This position supports commercial contracting, litigation management, corporate governance, intellectual property, compliance initiatives, legal operations, budgeting, transparency reporting, and state licensing activities. The role serves as a key liaison among Legal, Compliance, Regulatory Affairs, Quality, Finance, Commercial, and external counsel to ensure legal and regulatory obligations are met efficiently and effectively. The ideal candidate is highly organized, detail-oriented, proactive, and capable of managing multiple priorities in a fast-paced, highly regulated pharmaceutical environment. Essential Duties and Responsibilities: • Legal Operations & Contract Management, • Draft, review, revise, and administer standard legal agreements, including confidentiality agreements, consulting agreements, vendor agreements, and other commercial contracts., • Coordinate contract review and approval processes with internal stakeholders and outside counsel., • Maintain and administer the company's contract lifecycle management system and legal document repository., • 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., • Litigation & Dispute Management, • Support litigation, arbitration, investigations, and other dispute resolution matters., • Manage legal holds and document preservation efforts., • Coordinate collection, review, and production of documents in response to litigation, subpoenas, audits, and regulatory requests., • Act as primary liaison with outside counsel regarding case administration and document management., • Maintain litigation files, status reports, and tracking databases., • Corporate Governance & Corporate Records, • Maintain corporate records, corporate filings, and governance documentation., • Assist, as needed, with preparation of board and committee meeting materials, resolutions, and written consents., • Support corporate entity management, annual reports, and secretary of state filings., • Coordinate signatures and execution of corporate documents., • Intellectual Property Support, • Assist with administration of patent, trademark, copyright, and trade secret matters., • Maintain intellectual property databases and filing calendars., • Coordinate communications with outside intellectual property counsel., • Track filing deadlines, renewals, and maintenance requirements., • Compliance & Transparency Reporting, • Support corporate compliance initiatives and legal compliance programs., • Assist with Open Payments and other transparency reporting requirements., • Collect, validate, and organize compliance-related data from internal stakeholders., • Support compliance monitoring, auditing, and investigation activities as needed., • Coordinate legal and compliance training programs and maintain training records., • Maintain policies, procedures, and compliance documentation., • Regulatory Compliance & State Licensing, • Assist with the preparation, submission, renewal, and maintenance of state licenses, registrations, permits, and related regulatory filings across multiple jurisdictions., • Maintain licensing databases, records, and compliance calendars to ensure timely renewals and filings., • Coordinate with state regulatory agencies regarding applications, amendments, renewals, inspections, and inquiries., • Monitor changes in state and federal licensing requirements and communicate impacts to appropriate stakeholders., • Support licensing and regulatory activities related to new products, acquisitions, facility changes, and business expansion initiatives., • Assist with preparation and coordination of responses to regulatory inspections, audits, and agency requests., • Maintain organized records of licenses, permits, registrations, certifications, and related supporting documentation., • Identify potential licensing compliance issues and escalate concerns to Legal and Regulatory Affairs leadership., • Financial Management & Legal Spend Administration, • Review, process, and track invoices from outside counsel and legal service providers., • Ensure invoices comply with billing guidelines and approved budgets., • Coordinate invoice approvals and payment processing., • Prepare legal spend reports, accruals, forecasts, and budget analyses., • Assist in management of outside counsel and vendor relationships., • Administrative Support, • Manage Legal Department records and filing systems., • Schedule meetings and coordinate communications with internal and external stakeholders., • Prepare correspondence, presentations, reports, and other legal documents., • Maintain confidentiality of sensitive legal, commercial, and regulatory information., • Support special projects and other duties as assigned. Education and/or Experience: • Bachelor's degree preferred., • Paralegal Certificate from an ABA-approved or accredited program preferred., • Minimum of 5 years of paralegal, legal operations, compliance, or related legal support experience., • Experience supporting an in-house legal department strongly preferred., • Pharmaceutical, biotechnology, healthcare, or other highly regulated industry experience preferred., • Experience with state licensing, regulatory compliance, or healthcare regulatory matters preferred. Knowledge, Skills & Abilities: • 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., • Experience with contract lifecycle management systems and legal matter management software preferred., • Ability to handle confidential and sensitive information with discretion and professionalism., • Strong attention to detail and commitment to accuracy., • Additional Competencies:, • Integrity and professionalism, • Sound judgment and discretion, • Accountability, • Collaboration and teamwork, • Initiative and proactive problem-solving, • Customer service orientation Physical Requirements and Working Conditions: The physical requirements and working conditions listed for this job are representative of those required on the job. Reasonable accommodation may be provided to enable qualified individuals with disabilities to perform the essential duties and responsibilities. Computer keyboarding, computer monitor and mouse use include reaching forward, grasping, finger and wrist manipulation, and neck bending and turning: near vision is necessary for computer monitor use. Occasional ability to lift and carry files and materials up to 20 pounds. Frequently required to stand, sit, walk, talk and hear, occasionally required to reach with hands. To perform this job successfully, an individual must be able to perform the essential job functions satisfactorily. PAI is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, PAI will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer. PAI uses E-Verify. PAI Pharma is a nicotine-free campus, meaning the use of nicotine products—including cigarettes, vaping, chewing tobacco, and any other nicotine-containing substances—is strictly prohibited on company property. All employees should be able to complete their full shift without the need to use nicotine. By joining PAI Pharma, you agree to adhere to our nicotine-free workplace policy, which supports a healthier environment for all employees. EEO Employer / Veteran / Disabled
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