Paralegal

Position Summary

Job Responsibilities

• Contract Management: Assist in drafting, reviewing, and maintaining Vendor Qualification documents, Quality Agreements, and Audit Reports. Ensure all agreements are complete, unexpired, and compliant with company policies and FDA regulations.
• Regulatory Compliance: Support the legal team in ensuring that the company complies with all applicable pharmaceutical regulations, including FDA guidelines, drug safety laws, and pharmaceutical industry standards.
• Document Management: Maintain and organize FDA compliance documents and records, ensuring proper filing and compliance with retention policies.
• Prepare and Maintain Regulatory Compliance Activities Docket: Drawing on your paralegal experience, this activity involves preparing specific task lists and execution timelines and enforcing adherence to those timelines.
• Task Execution: Execute tasks in a disciplined and time-conscious manner to bring efficiency in daily tasks.

Experience Requirements

• At least 3 years of experience as a paralegal. No experience in the pharma industry is needed.
• Experience in a compliance-driven industry (banking, pharma, automotive, etc) is a plus.
• Strong organizational and time-management skills, attention to detail and accuracy are must.
• Excellent written and verbal communication with assertiveness
• Ability to work independently and as part of a team
• Proficient in Microsoft Office Suite and legal document management systems
• Ability to handle highly confidential information with discretion and professionalism. A proactive attitude with a willingness to learn and adapt to a fast-paced environment.

Education Requirements

• Paralegal certificate or a related degree from an accredited institution.
• EOE, including disability/vets