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
