Regulatory and Start Up Specialist - Remote

Overview

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.

In Short

• Responsible for delivery of site activation readiness within assigned country/sites.
• Preparation of Clinical Trial Application Forms and submission dossiers.
• Interaction with Competent Authorities and Ethics Committees.
• Providing updates about submissions to the Start Up Lead and Project Manager.
• Maintenance of project plans and regulatory intelligence tools.
• Preparation of study specific start-up plans and essential document review criteria.
• Partner with site CRA for communication alignment.
• Review and manage collection of essential documents for site activation.
• Customize Patient Information Sheets and Informed Consent Forms.
• Maintain communication with key functions on project status.

Requirements

• Bachelor’s degree in life sciences or related field, or equivalent.
• 1 year or more as a Regulatory or Start Up specialist in CRO or pharmaceutical industry.
• Strong communication and organizational skills.
• Experience with computerized information systems and electronic spreadsheets.
• Fluency in English.

Benefits

• Opportunity to work in a growing organization.
• Contributions are valued and nurtured.
• Impact positive change for the company.