Regulatory and Start Up Specialist

Job Description

Precision for Medicine is seeking a Regulatory and Start Up Specialist to join their team in Belgium. This is a fully remote position.About the Company:Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and data sciences to help life sciences companies improve the speed, cost, and success rate of bringing therapies to patients.Role Involves:

• Delivery of site activation readiness.
• Preparation of Clinical Trial Application Forms.
• Preparation of submission dossier.
• Interaction with CA/EC for study purposes.
• Providing regular updates about CA and EC submissions.
• Maintenance of project plans and regulatory intelligence tools.
• Development of study specific start-up plans.
• Customizing country/site specific Patient Information Sheet and Informed Consent Form.
• Facilitating the translation and co-ordination of translations for documents.
• Maintaining communication with other key functions.
• Acting as SME for collection and maintenance of site level critical path to Site Activation data points.
• Participating/supporting the negotiation of study budgets.
• Keeping an updated knowledge of the local clinical trial laws and regulations.
• Maintaining audit/inspection readiness.
• Supporting the clinical team performing Pre-Study Site Visits.

Requirements:

• Bachelor’s degree in life sciences or related field.
• 1 year or more as a Regulatory or SU specialist in a CRO or pharmaceutical/biotech industry.
• 1 year or more in part II submissions for clinical trials in Belgium and/or Netherlands.
• 1 year or more for ICF country adaptation for Belgium and/or Netherlands.
• 1 year or more in site level documents collection for submissions and IP release for Belgium and/or Netherlands.
• Regulatory/ SU experience for covering Belgium and the Netherland.
• Fluency in English, Dutch and French.
• Strong communication and organizational skills.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail.

Role Offers:

• Fully home based position.
• Opportunity to work with a growing organization.
• Valued input and ideas.