Agency Temporary - Regulatory Clinical Science Specialist

Role Summary

The Contingent Worker- Regulatory Clinical Science Specialist will report to the Director, Regulatory Clinical Science and contribute to maintaining global clinical regulatory compliance for investigational and marketed products. They will assist in maintaining study files in eCTD format and support clinical programs by accurately and efficiently filing appendices in clinical study reports and ensuring ongoing regulatory compliance.

Responsibilities

• 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.

Qualifications

• Required: Bachelor’s degree in life sciences or a related field; 3+ years of relevant regulatory clinical science experience
• Required: Master’s degree in life sciences or a related field; 2+ years of relevant regulatory clinical science experience
• Preferred: Mid-level regulatory or clinical operation expertise
• Preferred: Experience in the preparation of the submission of clinical modules in eCTD format
• Preferred: Familiar with organizing responses to Health Authority information requests
• Preferred: Familiarization with regulatory submissions internationally

Skills

• Knowledge of Health Authority clinical guidance documents and requirements
• Knowledge of clinical research, Good Clinical Practices, and regulatory requirements and guidelines
• Strong attention to detail
• Strong knowledge of clinical documentation and terminology
• Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
• Strong organizational and written and oral communication skills

Additional Requirements

• This is a full-time position on-site (40 hours per week).
• Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval.
• Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
• This desk-based role involves close study of scientific and regulatory documents and collaboration with scientific colleagues on project teams.
• Lift and carry materials weighing up to 20 pounds.