(Senior) 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

• Hiring a (Senior) Regulatory and Start Up Specialist with contracts and budget experience.
• Position can be fully home based.
• Responsible for site activation readiness within assigned country/sites.
• Maintain communication with key functions participating in country start up.
• Act as SME for site level critical path to Site Activation data points.
• Participate in negotiation of study budgets and investigator contracts.
• Requires Bachelor’s degree in life sciences or related field.
• 1 year or more as a Regulatory/SU specialist in CRO or pharmaceutical industry.
• Fluency in French and English is required.
• Strong communication and organizational skills are essential.

Requirements

• Bachelor’s degree in life sciences or related field.
• 1 year or more as a Regulatory/SU specialist.
• Experience drafting, reviewing and negotiating agreements.
• Experience developing and negotiating budgets.
• Strong communication and organizational skills.
• Experience using computerized information systems.
• Fluency in French and English.
• Knowledge of Good Clinical Practice/ICH Guidelines.
• Ability to work independently in a fast-paced environment.
• Occasional travel may be required.

Benefits

• Opportunity to impact positive change for the company.
• Employees feel appreciated for their contributions.
• Input and ideas are valued and nurtured.
• Work in a growing organization serving clients in cancer therapies.