Cecilia Njenga

Clinically trained Physician Associate turned Regulatory Medical Writer with over five years’ experience across clinical research, medical education, and regulatory submissions. Experienced in authoring Clinical Study Reports (CSRs), study protocols, and CTD Modules 2.7.3 (Clinical Efficacy) and 2.7.4 (Clinical Safety) for EMA submissions in oncology, neurology, and cardiology. Strong command of ICH and GCP standards with proven ability to translate complex clinical data into clear, compliant, and scientifically robust documentation.

Recognised for analytical precision, cross-functional collaboration, and the ability to deliver high-quality, data-driven narratives supporting global regulatory strategies. Significant interest in Digital Clinical Safety (DCB0129/0160) and AI-in-Healthcare.

Regulatory Medical Writer (Contract, Part-Time)

Propharma| May 2022 - Present

• Contributed to the preparation and review of key clinical and regulatory documents including Clinical Study Protocols (CSPs), Clinical Study Reports (CSRs), and Informed Consent Forms (ICFs). 
• Collaborated with cross-functional teams to ensure scientific accuracy, consistency, and compliance with regulatory and ethical standards. 
• Interpreted and summarised clinical data to support clear, patient-centred communication across study documentation, and demonstrated strong alignment between clinical insight and technical writing accuracy. 
• Ensured document quality through adherence to SOPs and internal quality control (QC) processes.
• Performed comprehensive QC and editorial review of key regulatory documents including Investigator’s Brochures (IB), CSRs, CSPs, Informed Consent Forms and CTD Modules 2.7.3, 2.7.4 and 5.
• Executed detailed cross-checks of CSRs against TLFs to verify accuracy and consistency of efficacy and safety data, ensuring alignment with statistical outputs.
• Reviewed and refined safety narratives, IB safety updates and IMPD/IND sections for clarity, structure, data integrity and adherence to regulatory requirements.
• Ensured document formatting, referencing, terminology and messaging were consistent across sections, supporting submission-readiness and audit compliance.
• Applied established QC processes to identify discrepancies, resolve content gaps and maintain high editorial standards across all deliverables.
• Collaborated effectively within eDMS environments to review, edit and approve controlled documents, maintaining version integrity and workflow compliance.

Physician Associate in Liaison Psychiatry

Royal National Orthopaedic Hospital NHS Trust (RNOH) | February 2021 – Present

• Conduct psychiatric assessments within inpatient and outpatient settings, formulating patient-centred care plans within multidisciplinary teams.
• Designed and delivered simulation-based teaching in psychiatry and acute care, integrating real-case scenarios to enhance clinical reasoning and communication skills.
• Supervised healthcare students during clinical placements, promoting clinical learning and reflective practice.
• Conducted audits, contributed to internal policy development and led a Quality Improvement (QI) project to strengthen psychiatric service delivery.

Physician Associate in Clinical Research

National Institute of Health Research, Imperial Clinical Research Facility | April 2019 - February 2021

• Supported multidisciplinary teams conducting clinical trials in oncology, gene therapy, and vaccine research.
• Performed screening obtained, consent, administered medication, and safety monitoring according to GCP.
• Contributed to recruitment and accurate entry of research data into electronic databases.
• Assisted in clinical documentation review and reporting, strengthening precision in medical communication.

Education

University of Hertfordshire | September 2023 - July 2024

PgCert Health and Medical Simulation

Modules: Health and Medical Simulation: Design and Delivery; Medical Emergencies and Human Error

St. George's University of London | September 2016 - August 2018

MSc Physician Associate Studies

 Clinical Placements: GP, Psychiatry, Acute Medicine, A&E, Obstetrics, Paediatrics, and Breast Surgery

Project: Acute Exacerbation of Asthma Review in Primary Care

University of Hertfordshire | September 2012 - July 2016

BSc (Hons) Applied Biomedical Science

 Industry Placement: Clinical Genetics Laboratory, Addenbrooke’s Hospital

Project: Bioinformatic Analysis of HER2 in Endometrial Cancer

Qualification

Digital Health and AI

• Artificial Intelligence in Healthcare - Royal College of Surgeons in Ireland (RCSI) and Microsoft (2025)
• Introduction to AI in Healthcare - Health AI CPD (2025)
• Digital Clinical Safety (DCB0129/DCB0160) – Essentials and Intermediate (NHS Digital, 2024 & 2025)

Additional Qualifications

• Good Clinical Practice (GCP) - National Institute for Health and Care Research (2025)
• 15-Minute CBT - Royal College of Psychiatrists (2022)
• IBMS Certificate of Competence - Institute of Biomedical Science (2016)