Job Description
Regulatory Clinical Science Specialist Company Overview : This organization is a commercial-stage biotechnology company focused on developing innovative immunotherapy and cell-based treatments designed to strengthen the body’s natural immune response.
What You Will Be Doing - Report to the Director, Regulatory Clinical Science and be responsible for contributing to the maintenance of global clinical regulatory compliance for investigational and marketed products and contribute towards the maintenance of study files in eCTD format.
- Support the organization in the management and conduct of clinical programs, focusing on accurately and efficiently filing appendices in clinical study reports and maintaining files to ensure ongoing compliance with regulatory requirements.
- Accurately and efficiently file documents for Appendix 16.1.4 and 16.1.5 of the clinical study report for all active clinical studies
- Ensure that all documents are properly labeled, dated, and stored in accordance with company policies and regulatory requirements
- Help with filing documents for closing clinical studies, ensuring that all necessary appendices are accounted for and properly stored in accordance with ICH E3 guidance
- Maintain accurate records of filed documents, including updating tracking systems and databases as needed
- Collaborate with team members to ensure that documents are filed and formatted correctly and that any issues are resolved promptly
- Create and maintain project plans
- Create, edit and adhere to Standard Operating Procedures (SOPs).
- Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.
What you will bring to the table: - Bachelor’s degree in life sciences or a related field required; 3+ years of relevant regulatory clinical Science experience is required ; OR
- Master’s degree in life sciences or a related field required; 2+ years of relevant regulatory clinical Science experience is required
- Mid-level regulatory or clinical operation expertise preferred
- Experience in the preparation of the submission of clinical modules in eCTD format is preferred
- Familiar with organizing responses to Health Authority information requests is preferred
- Familiarization with regulatory submissions internationally is preferred.
- Knowledge of Health Authority clinical guidance documents and requirements
- Knowledge of clinical research, Good Clinical Practices, and regulatory requirements and guidelines
- Strong knowledge of clinical documentation and terminology
- Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
- Strong organizational skills, written and oral communication skills, and attention to detail
Please reach out to
[email protected] to learn more about this fantastic opportunity! Reference Job# 19611
Job Tags
Permanent employment, Temporary work,