Under the general direction of Director of Compliance & Legal Affairs, the Compliance Associate & Paralegal will be responsible for supporting compliance with regulatory requirements for wholesale distributor engaged in the warehousing and shipment of prescription pharmaceuticals and devices, medical supplies, nutritional products, and food supplements. This position will be responsible for maintaining Direct Relief’s distributor licensing, creating and maintaining compliance documentation, assisting with the ongoing process of creating and revising standard operating procedures (“SOPs”), supporting compliance audits and investigations, and supporting the revision and management of agreements with donors and Direct Relief program partners.
Essential Tasks, Duties, and Responsibilities
As directed by the Director of Compliance & Legal Affairs, the Compliance Associate & Paralegal will perform functions including but not limited to the following:
- Assist in the day-to-day operation of the compliance program;
- Work closely with Operations and Programs staff to perform ongoing duties related to the management of records and data, including reference documents and forms supporting SOPs;
- Draft new and renewal applications for all licenses and permits required for the wholesale distribution of pharmaceuticals and devices, nutritional products, and food supplements;
- Assist in the preparation, day-of coordination, and responses for all compliance audits;
- Support Compliance Monitoring and Internal Audit Program, International Program Audit and Compliance Program, Vendor/Supplier Audit Program, and investigation of compliance matters for resolution as necessary;
- Review and maintain contract files to track versioning, inclusion of standard terms, and to verify execution and filing.
Qualifications, Knowledge, and Skills:
- Bachelor’s degree required;
- 1-3 years related experience in regulatory environment and/or paralegal experience preferred;
- Superior written and verbal communication skills;
- Superior attention to detail and organizational skills;
- Versatility and flexibility;
- Excellent interpersonal skills;
- Ability to effectively manage multiple projects concurrently, independently and on a team;
- Ability to work well with all levels of staff;
- It is the responsibility of every employee to contribute to a positive work environment through cooperative and professional interactions with co-workers, vendors, and constituents;
- Clear background check;
- Clear toxicology screening.