Associate Director, Clinical Compliance & Records
New
A
Amylyx PharmaceuticalsBiotechnology
You must reside and work within the United States, and in a state where Amylyx currently does businessFull-TimeManager
Salary171,000 - 192,000 USD per year
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Job Details
- Experience
- 8+ years
- Required Skills
- SharePointMicrosoft OfficeProcess improvement
Requirements
- Bachelor’s degree in a health-related or scientific discipline.
- 8+ years of pharmaceutical or biotechnology industry experience in Clinical Compliance and/or TMF roles.
- In-depth knowledge of ICH/GCP standards and FDA guidelines.
- Proficiency with the TMF Reference Model.
- Strong proficiency in MS Office (Word, Excel, SharePoint, PowerPoint).
- Excellent interpersonal, communication, organizational, and time management skills.
- Ability to work in a fast-paced small company environment.
- Preferred: Experience supporting FDA, EMA, or MHRA inspections.
- Preferred: Working knowledge of Veeva Clinical and Veeva Quality workflows.
- Preferred: Prior experience as a Business Administrator over eTMF systems.
Responsibilities
- Provide guidance to Study Management Teams on ICH-GCP standards, FDA guidelines, and regulatory requirements.
- Manage study-related risks, lead investigations, and support CAPA activities.
- Partner with cross-functional teams to manage Quality Events, risk assessments, and sponsor oversight documentation.
- Facilitate inspection readiness activities, including preparation, participation, and follow-up for regulatory inspections.
- Provide leadership for Clinical Records strategy, including eTMF processes, migrations, and TMF plan development.
- Monitor TMF health, provide metrics, and ensure TMF content meets quality standards.
- Collaborate with internal and external stakeholders to resolve TMF quality issues and implement process improvements.
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