Clinical Regulatory Affairs Expert

About Cobalt

Cobalt operates as a data research laboratory advancing the frontier of artificial intelligence, particularly connecting AI research teams with expert data to support large-scale intelligent systems development across healthcare, life sciences, and robotics sectors.

Role Overview

Cobalt seeks experienced clinical regulatory experts familiar with drafting or reviewing Clinical Study Reports (CSRs). This role suits regulatory medical writers, regulatory affairs specialists, clinical submission professionals, clinical development practitioners, and CRO experts knowledgeable in documenting clinical trial outcomes for regulatory assessment. The position involves evaluating regulatory documents, composing or updating CSR content, and verifying accuracy, consistency, completeness, and adherence to regulatory standards.

Key Responsibilities

• Prepare, critique, or amend Clinical Study Reports and CSR subsections.
• Evaluate clinical documents for precision, uniformity, completeness, and traceability.
• Interpret protocols, statistical analyses, tables, listings, figures, and supplementary materials.
• Detect inconsistencies between study data, source documentation, and conclusions.
• Analyze narratives related to efficacy, safety, methodology, and patient disposition.
• Employ standardized CSR frameworks, templates, style guides, and regulatory writing norms.
• Determine document readiness for regulatory or scientific scrutiny.
• Incorporate inputs from regulatory, clinical, medical, safety, and statistical contributors.

Qualifications and Skills

• Hands-on experience leading or substantially reviewing at least one Clinical Study Report.
• Background in regulatory writing, regulatory affairs, clinical submissions, or clinical development.
• Strong comprehension of clinical trial documentation and regulatory reporting requirements.
• Capability to interpret clinical trial protocols and statistical data outputs.
• Excellent scientific writing, editing, and document assessment skills with high attention to detail and accuracy.
• Familiarity with ICH E3 guidelines is advantageous.
• Preferred advanced degree in science, medicine, pharmaceuticals, or regulatory affairs.
• Experience in pharmaceutical, biotechnology, medical device industries, CROs, or regulatory consultancy is beneficial.

Engagement Terms

• Independent contractor status on a project basis.
• Work is entirely remote with flexible scheduling.
• Project scope, schedule, and remuneration are negotiated on a per-project basis.
• Opportunity for continued or additional projects based on performance and availability.