eTMF Specialist
New Jersey (Hybrid)
$90,000 - $100,000
Job Description
EPM is partnered with a company focused on creating novel therapeutic bi-specific, multi specific, and ADC's for cancer treatment. With their clinical stage assets, the data has been described as "the best I've ever seen" by industry leaders, and they signed a licensing agreement with a big pharma company at the end of last year worth multiple billion dollars. Given their science and financial backing along with the opportunity for growth, it's a really high potential opportunity. They're growing out a new office in New Jersey, so it's a very exciting time to join!
Roles & Responsibilities
- Maintain and manage the eTMF system to ensure it meets regulatory requirements and internal standards
- Oversee the organization and filing of trial documentation within the eTMF, ensuring completeness, accuracy, and compliance with regulatory guidelines
- Prepare the eTMF for audits and inspections by the regulatory authorities, ensuring all documents are readily accessible and compliant with audit trials
- Continuously evaluate and improve eTMF processes and workflows to enhance efficiency and compliance
Key Qualifications
- 3-4 years of experience working in the eTMF space
- At least 2 years of experience with Veeva Vault
- Ability to come onsite 1x/week
- Coming from a biotech or pharmaceutical background (no CRO)
Benefits
- Medical
- Dental
- Vision
- 401(k)
