Associate Director, TMF & Clinical Compliance

Amylyx Pharmaceuticals; Cambridge (MA); Hybrid; USD 171,000 - 192,000; Full time

Benefits offered by this job

Remote-friendly work environment

Paid travel to corporate location

Comprehensive benefits package

Job summary

Amylyx Pharmaceuticals in Cambridge, MA is seeking an Associate Director of Clinical Compliance & Records responsible for ensuring compliance with clinical study regulations.

The ideal candidate will have extensive experience in the pharmaceutical industry, guiding Study Management Teams on ICH/GCP standards, and overseeing Trial Master File processes. A bachelor's degree in a science discipline is required, along with strong interpersonal and organizational skills.

Qualifications

• 8+ years of experience in pharmaceutical or biotechnology industry focused on Clinical Compliance.
• Experience with ICH/GCP standards and FDA guidelines.
• Enthusiastic about working in a fast-paced environment.

Responsibilities

• Guide SMTs on ICH-GCP standards and FDA guidelines.
• Lead investigations and CAPA activities.
• Ensure compliance with clinical trial regulations.

Skills

Interpersonal skills

Organizational skills

Communication skills

Time management skills

Education

Bachelor’s Degree in a health-related or scientific discipline

Tools

MS Office

Veeva Clinical

Job description

Amylyx Pharmaceuticals in Cambridge, MA is seeking an Associate Director of Clinical Compliance & Records responsible for ensuring compliance with clinical study regulations.

The ideal candidate will have extensive experience in the pharmaceutical industry, guiding Study Management Teams on ICH/GCP standards, and overseeing Trial Master File processes. A bachelor's degree in a science discipline is required, along with strong interpersonal and organizational skills.