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Job Description
Precision for Medicine is seeking a Senior Regulatory and Start Up Specialist to join their team in the UK. This is a remote position where the candidate will be responsible for ensuring the timely and quality delivery of site activation readiness. The Senior Regulatory and Start Up Specialist will work to mitigate any risks associated with site activation.
The role involves:
- Preparing Clinical Trial Application Forms and submission dossiers.
- Interacting with regulatory authorities and ethics committees.
- Providing regular updates to the Start Up Lead, Regulatory Lead, and Project Team.
- Maintaining project plans and regulatory intelligence tools.
- Preparing study-specific start-up plans and essential document review criteria.
- Partnering with site CRAs to ensure alignment in communication.
- Customizing Patient Information Sheets and Informed Consent Forms.
- Coordinating translations for required documents.
- Negotiating study budgets and investigator contracts.
Requirements:
- Bachelor’s degree in life sciences or related field, or Registered Nurse (RN).
- 3.5+ years of experience as a Regulatory or Start-Up Specialist in a CRO or pharmaceutical/biotech industry.
- Excellent communication and organizational skills.
- Fluency in English.
- Knowledge of Good Clinical Practice/ICH Guidelines.
Precision for Medicine offers:
- Fully remote work
