Gloria Effah

Regulatory Medical Writer with over one year of dedicated RMW experience delivering clinical and regulatory documentation across CSR, CTD, Investigator Brochure and clinical protocol document types, familiar with EMA, MHRA and FDA documentation and submission requirements. Brings a strong clinical nursing background spanning general medicine, cardiac intensive care, and complex care settings, providing a robust clinical foundation for producing accurate, submission-ready regulatory content. Skilled in safety narrative development, clinical data interpretation, and patient and family-facing clinical communication, with a consistent focus on data accuracy, regulatory compliance and document clarity.

Driven by a commitment to evidence-based practice and a proven ability to translate complex clinical information into clear, compliant written outputs.

Regulatory Medical Writer, Permanent, Remote - Remote

(2025-05)

• Delivered submission-ready sections of Clinical Study Reports (CSRs) in line with ICH E3 standards, drawing on direct clinical nursing knowledge to ensure scientific accuracy and data traceability throughout.
• Produced patient safety narratives and AE/SAE documentation to ICH E3 standard, ensuring consistent structure, QC-verified accuracy and full source-data traceability across all data, tables and references confirmed at finalisation.
• Contributed to clinical study protocols and protocol-related documentation to ICH E6 (GCP) standard, applying frontline clinical experience to ensure scientific and procedural accuracy, with reviewer comments resolved within agreed timelines.
• Supported development of Module 2.7.4 clinical safety summary sections integrating TEAEs, SAEs and AESIs in line with ICH M4E and EMA/MHRA CTD requirements, with cross-functional review comments resolved prior to finalisation.
• Contributed to Investigator Brochure safety-update content, synthesising clinical and scientific input into concise, evidence-based text accepted without material revision for investigator audiences.
• Strengthened document accuracy through systematic QC and consistency review across multiple regulatory documents, with outputs confirmed to submission standard prior to finalisation.

General Medicine Ward Nurse - Portsmouth University Hospital - Portsmouth, UK

(2023-01 - 2026-01)

• Delivered comprehensive nursing care across a broad range of acute and chronic conditions, including cardiovascular, respiratory, gastrointestinal, endocrine, neurological, renal, haematology and oncology presentations, maintaining accurate clinical assessment and documentation throughout.
• Coordinated care across multidisciplinary teams to ensure optimal patient outcomes, accurately interpreting and communicating evolving clinical data across complex, multi-comorbidity caseloads.
• Educated patients and families on condition management and treatment plans, translating complex clinical information into clear, accessible guidance.

Complex Care Nurse - OneCall24

(2023-01 - 2024-01)

• Monitored respiratory status and tracheostomy sites to detect complications early, applying rigorous clinical assessment to maintain patient safety.
• Evaluated medication history, allergies and potential drug interactions prior to administration, ensuring safe and accurate medication management with close monitoring of patient response.
• Delivered coordinated, multidisciplinary care for patients with complex clinical and behavioural needs, supporting safe PEG tube feeding and patient independence.

Cardiac Intensive Care Nurse - Southampton General Hospital

(2021-01 - 2023-01)

• Monitored and assessed critically ill cardiac patients, including acute coronary syndromes, heart failure, arrhythmias and post-cardiac surgery cases, ensuring timely clinical intervention.
• Administered and titrated vasoactive and antiarrhythmic medications accurately under critical care protocols, maintaining patient safety throughout.
• Managed mechanical circulatory support and ventilation equipment in collaboration with cardiologists, cardiothoracic surgeons and respiratory therapists, supporting safe, coordinated critical care delivery.
• Maintained accurate, complete clinical documentation in electronic medical records, supporting continuity of care and clinical traceability.

Support Worker - Glory Care Agency / Aster Care Limited / Choice Care Group

(2015-01 - 2023-01)

• Delivered complex care to clients with significant behavioural, psychological and developmental needs, including tracheostomy and PEG feed medication administration and airway suctioning.
• Maintained accurate care documentation and liaised with care managers to ensure care plans were followed and client needs were consistently met.

Healthcare Assistant - Home of Comfort and Universal Care Agency

(2013-01 - 2015-01)

• Delivered personal care and support to frail, elderly and disabled clients in line with individual care plans, contributing to stakeholder meetings and maintaining accurate care records.

Master of Science - Nursing - Coventry University (2024-01)

BN (Hons) - Adult Nursing - University of Portsmouth (2018-01 - 2021-01)

Level 3 Diploma - Health and Social Care (Adult) - Millennium Academy (2017-01 - 2018-01)