Similar Jobs
See allRegulatory and Start Up Specialist
Precision for Medicine
Spain
Regulatory Affairs
Contract Negotiation
Clinical Trials
Study Start Up Specialist/Sr. Study Start Up Specialist
Ergomed
US
ICH GCP
Regulatory Submissions
MS Office
Freelance Site Activation Specialist
IQVIA
UK
Regulatory Affairs
Clinical Research
Document Review
Clinical Project Specialist
ProTrials
US
Clinical Research
Project Management
Regulatory Compliance
Clinical Coordinator
Tiny Health
North America
Clinical Research
Regulatory Compliance
Project Management
Responsibilities:
- Responsible for delivery of site activation readiness within assigned country/sites.
- Prepare submission dossiers for Competent Authorities and Ethics Committees.
- Maintain communication with start-up lead, clinical operations, and site contracts group.
Qualifications:
- Bachelor's degree in life sciences or related field, or RN.
- 3.5+ years as regulatory or start-up specialist in CRO or pharma.
- English proficiency and excellent communication skills.
Competencies:
- Knowledge of Good Clinical Practice and ICH guidelines.
- Ability to work independently in a fast-paced environment.
- Excellent organizational and computer skills.
Precision Medicine Group
We are a global life sciences company specializing in clinical trial regulatory and start-up services. We are expanding our capabilities across Latin America and seek experienced professionals to join our team.