Position Summary
Exela Pharma Sciences is seeking a highly motivated, detail-oriented and assertive individual to join our fast-growing company in this non-traditional, yet highly fulfilling career track. The ideal candidate will support our attorneys in our Quality Assurance department in a variety of functions related to the pharmaceutical industry, including regulatory compliance, manufacturing operations, contract management, while driving efficiencies in executing daily tasks with a sense of urgency.
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