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 Precision for Medicine as a Regulatory and Start Up Specialist.
• Responsible for site activation readiness in Taiwan.
• Prepare Clinical Trial Application Forms and submission dossiers.
• Interact with CA/EC for study purposes.
• Maintain project plans and regulatory intelligence tools.
• Customize Patient Information Sheets and Informed Consent Forms.
• Ensure compliance with local clinical trial laws and regulations.
• Participate in budget negotiations and investigator contracts.
• Support feasibility assessments for potential studies.
• Maintain audit readiness and file documents as per TMF plan.

Requirements

• Bachelor’s degree in life sciences or related field.
• 1 year of experience as a Regulatory or Start Up specialist.
• Experience with Taiwan FDA submissions.
• Strong communication and organizational skills.
• Fluency in English.
• Experience using computerized information systems.
• Advanced degree in medical or life sciences preferred.
• Ability to prioritize workload to meet deadlines.
• Experience in contract negotiations is a plus.
• Knowledge of local clinical trial laws.

Benefits

• Work in a growing organization focused on life sciences.
• Contribute to impactful cancer therapies.
• Flexible working arrangements with remote options.
• Collaborative and supportive work environment.
• Opportunities for professional development.
• Employee recognition and appreciation programs.
• Access to advanced technologies and resources.
• Engagement in meaningful projects.
• Inclusive workplace culture.
• Equal Opportunity Employer.