Senior Scientist, Regulatory & Clinical Operations

What this role involves

Hims & Hers is seeking a Senior Scientist for Regulatory & Clinical Operations to coordinate FDA-regulated studies, work with a CRO, and perform hands-on assay testing. The role is on-site in Central New Jersey and requires expertise in clinical study coordination, regulatory compliance, and laboratory techniques.

Skills this posting asks for

• fda regulations
• gcp
• clinical study coordination
• cro management
• protocol development
• irb submissions
• root cause analysis
• capa
• assay development
• validation
• clsi guidelines
• roche cobas
• lc-ms/ms
• sciex 4500md
• sample logistics
• data management
• quality assurance
• cap
• clia
• audit preparation

Requirements

• Level: senior
• Remote policy: onsite

From the employer’s posting

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment t…