Offer summary
Qualifications:
Associate’s or Bachelor’s degree in allied health field or relevant experience, 3-5 years of pharmaceutical, site, or CRO Regulatory experience.
Key responsabilities:
- Advise project teams on regulatory requirements for clinical studies
- Perform compliance assessments, adapt study documents, and compile Regulatory documentation
- Assist in IRB/EC submissions, interact with site personnel, and manage study documentation
- Prepare CTAs, respond to Deficiency Letters, and oversee translation of regulatory documents
- Assist with QC of study related documents, prep for audits, and provide status reports