Regulatory and Start Up Specialist - Remote

Overview

Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences.

In Short

• Join our team as a Regulatory and Start Up Specialist.
• Responsible for site activation readiness in assigned country/sites.
• Prepare Clinical Trial Application Forms and submission dossiers.
• Interact with CA/EC for study purposes.
• Maintain project plans and regulatory intelligence tools.
• Customize country/site specific Patient Information Sheets.
• Ensure compliance with local clinical trial laws and regulations.
• Act as SME for site activation data points.
• Participate in budget negotiations and investigator contracts.
• Keep updated knowledge of local clinical trial laws.

Requirements

• Bachelor’s degree in life sciences or related field.
• 1 year or more as a Regulatory or SU specialist.
• Experience in submissions to the Taiwan FDA.
• Strong communication and organizational skills.
• Fluency in English.
• Experience using computerized information systems.
• Relevant regulatory and site start-up experience preferred.
• Advanced degree in medical or life sciences preferred.

Benefits

• Work in a growing organization.
• Contribute to impactful cancer therapies.
• Employee contributions are valued and appreciated.