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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 for study purposes.
- Providing regular updates on submissions to relevant teams.
- 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.
- Managing the collection of essential documents for site activation.
- 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.
- Experience using computerized information systems.
- Fluency in English.
- Knowledge of local clinical trial laws and regulations.
Precision for Medicine offers:
- A fully remote position based in the UK.
- The opportunity to work with new technologies and expertise.
- A chance to improve the speed, cost, and success rate of bringing life-changing therapies to patients.
