Chisomebi Okeke

Regulatory Medical Writer with over 5 years of experience specializing in regulatory writing and managing complex submissions across FDA, EMA, and MHRA guidelines. Proven capability in developing comprehensive regulatory dossiers compliant with CMC regulations, ensuring the highest standards of quality and data integrity. Core competencies include authoring Clinical Study Reports, CTD modules, and regulatory documentation while facilitating cross-functional collaboration to meet aggressive submission timelines.

Committed to enhancing submission readiness and achieving compliance objectives, ultimately delivering impactful outcomes in regulatory submissions.

Medical Writer at Plousios Gigantas Ltd (2026-01 – Present)

• Authored and finalized comprehensive regulatory dossiers, including Clinical Study Reports and CTD documents, to support FDA, EMA, and MHRA submissions with adherence to CMC regulations.
• Interpreted TLF datasets and statistical outputs to compose precise regulatory narratives, ensuring full traceability to source data and supporting compliance objectives.
• Boosted audit readiness for submissions by 30% through standardized documentation workflows and version control practices underpinned by CMC and ICH standards.
• Managed end-to-end regulatory document lifecycle, meeting tight deadlines across NDA and MAA submissions without compromising quality or compliance.
• Partnered seamlessly with biostatistics, data management, clinical operations, and regulatory affairs teams to resolve discrepancies in submissions aligned with regulatory requirements.
• Facilitated submission readiness through rigorous compliance checks with ICH E3, GCP, and CMC documentation standards.

Clinical Data Analyst / Medical Writing Support at Techy Jaunt Data Analysis Bootcamp (2024-09 – 2025-12)

• Conducted in-depth analyses of clinical datasets using Excel, SQL, and Power BI, directly supporting CMC regulatory writing and submission deliverables.
• Executed validation and reconciliation checks across TLF outputs, enhancing reporting accuracy and reducing discrepancies during the regulatory review cycles.
• Transformed statistical outputs into coherent clinical narratives utilized in CMC regulatory documentation and submission activities, elevating stakeholder understanding.
• Developed dashboards and data summaries that improved clinical reporting turnaround times by 20%, enhancing alignment with regulatory timelines.
• Collaborated with regulatory and analytics teams, aligning outputs with statutory guidelines of FDA and EMA to ensure compliance throughout documentation.

Research Medical Writer at Babcock University (2021-09 – 2023-09)

• Generated regulatory-compliant CSR reports and clinical summaries for academic and clinical research projects that adhered to CTD and CMC regulatory standards.
• Conducted comprehensive literature reviews using PubMed and EMBASE to substantiate Investigator Brochures and regulatory submissions, ensuring evidence-based content.
• Produced structured scientific content, successfully translating pharmacological and clinical findings into regulatory narratives compliant with industry standards.
• Advanced document quality checks and version control measures, significantly improving clarity and consistency of submissions.

Clinical Research & Regulatory Documentation Officer at Alex Ekwueme Federal University Teaching Hospital (2020-11 – 2021-10)

• Formulated protocols and research reports, contributing to regulatory documentation that bolstered adherence to GCP and audit compliance measures.
• Instituted data traceability processes and documentation workflows, enhancing audit transparency and overall quality of clinical records.
• Performed clinical data verification and compliance assessments, ensuring alignment with ethical and regulatory standards for documentation.
• Coordinated effectively with multidisciplinary clinical and research teams, guaranteeing timely delivery of accurate study documentation in compliance with regulatory requirements.

MSc in Biochemistry (Phytomedicine & Drug Discovery) – Babcock University

BSc in Applied Biochemistry – Nnamdi Azikiwe University