Profile Details

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Hire Cecilia N.

Andorra

USD 60 /hr

Clinical & Regulatory Medical Writer | CSPs, CSRs, IBs, CTD Modules 2.7.3/4 | QC & Editing

Profile Summary

I am a UK-based clinically trained physician associate and freelance medical writer with a background in NHS practice and clinical research. I provide clear, accurate clinical and regulatory writing to support pharmaceutical, biotechnology, and healthcare organisations. I can support: • Clinical Study Protocol (CSP), Investigators’ Brochure (IB), Clinical Study Report (CSR) and CTD module writing • Clinical and scientific content development • Document editing, formatting, and consistency checks • Cross-checking tables, figures, and references My clinical experience includes complex patient assessment, multidisciplinary working, and implementation of digital clinical pathways. I am available for remote, project-based work and can provide additional capacity for short-term or overflow assignments.

Subject Matter Expertise

• ☆ Psychiatry
• ☆ Regulatory Writing
• ☆ Clinical Trial Documentation
• ☆ Clinical Trial Protocol Writing
• ☆ Clinical Study Reports
• ☆ Medical Writing

Services

• Writing

Writing Clinical Trial Documentation, Medical Writing, General Proofreading & Editing

Work Experience

Regulatory Medical Writer (contractual)

Freelance

May 2022 - Present

Physician Associate - Liaison Psychiatry

NHS (UK)

February 2021 - Present

Physician Associate

National Health Service

April 2019 - Present

Physician Associate - Clinical Research

NHS (UK)

April 2019 - February 2021

Education

PgCert Health and Medical Simulation

University of Hertfordshire

September 2023 - July 2024

MSc Physician Associate Studies

Saint George's Hospital Medical School, University of London - United Kingdom

September 2016 - July 2018

BSc (Hons) Applied Biomedical Science

University of Hertfordshire

September 2012 - July 2016

Certifications

• Artificial Intelligence in Healthcare

  Rcsi

  November 2025 - Present

• Artificial Intelligence in Healthcare

  Microsoft

  November 2025 - Present

• Introduction to AI in Healthcare

  Health AI CPD

  October 2025 - Present

• Good Clinical Practice

  NIHR

  August 2025 - Present

• Digital Clinical Safety (DCB0129 & DCB0160) Essentials & Intermediate

  NHS

  October 2024 - Present

• IBMS Certificate of Competence

  IBMS

  September 2016 - Present

Publications

JOURNAL ARTICLE

Cecilia Njenga, Parashar Pravin Ramanuj, Frederico Jose Coelho de Magalhães, Harold Alan Pincus (2024). New and emerging treatments for major depressive disorder . BMJ.