Mobolaji Oke

A Clinical Pharmacist with an MSc in clinical pharmacy, 14 years of clinical and pharmaceutical experience, and expertise in translating complex scientific and clinical information into clear, accurate, and regulatory-compliant documents.

Experience in clinical study reports, protocols, investigator brochures, informed consent forms, and other documents in compliance with ICH E3, E6 (GCP), and the Common Technical Document (ICH M4) guidelines. Strong understanding of medicine, clinical data, and patient safety combined with attention to detail, document management, and cross-functional collaboration. I’m seeking a regulatory medical writing position where I can apply my pharmaceutical, clinical, and scientific knowledge, regulatory understanding, communication skills, and attention to detail to the development and review of high-quality documents across the product development lifecycle.

Regulatory Medical Writing Trainee (Project-Based) - PharmaLink Academy - United Kingdom

(2026-03 - 2026-08)

Regulatory Medical Writing Programme

• Drafted a full CSR-style report from a Phase II clinical dataset, applying ICH E3 structure across efficacy and safety sections and incorporating two rounds of senior reviewer feedback.
• Developed a clinical study protocol and amendment, including schedule of activities, aligned to ICH E6 (R2) requirements.
• Authored investigator’s brochure in compliance with ICH E6 (GCP) and ICH E3/CTD guidance, synthesizing nonclinical pharmacology, toxicology, and early clinical data into a cohesive safety profile.
• Interpreted tables, figures, and listings (TFLs) to construct efficacy and safety narratives, resolving data queries with reviewer input.
• Produced CTD Module 2.7.3 and 2.7.4 summary sections from pooled study data, maintaining consistency with source documents.
• Delivered all documents to fixed deadlines within structured review cycles, maintaining version control and a professional audit trail.

Clinical Care Support Worker - Exemplar Healthcare Limited - United Kingdom

(2023-09)

• Monitor and report clinical, physical, mental, and emotional health changes in service users to nursing staff, thereby enabling timely safety escalation and accurate source documentation.
• Execute individualized care plans, involving mealtime support and medication administration in strict adherence to safety, hygiene, and clinical care guidelines.
• Maintain detailed real-time logs of daily patient care activities and vital observations, ensuring high data integrity and compliance with healthcare documentation standards.
• Collaborate with multidisciplinary teams including nurses, therapists, and medical staff to support care delivery and communicate patient feedback effectively.

Clinical Pharmacist - Lagos State Health Service Commission - Nigeria

(2014-04 - 2022-09)

• Assessed and verified inpatient and outpatient prescriptions for potential medication errors, drug interactions, and dosage accuracy, ensuring strict adherence to Good Dispensing Practice and regulatory laws.
• Provided clear, evidence-based medication counselling and educational guidance to patients on proper drug usage, administration schedules, and adherence strategies to optimize therapeutic outcomes.
• Collaborated with multidisciplinary healthcare teams during clinical ward rounds to monitor patient pharmacotherapy, identify potential safety risks, and support evidence-based treatment decisions.

Bachelor of Pharmacy - University of Lagos, Nigeria (2011)

Master of Science - Clinical Pharmacy - University of Lagos, Nigeria (2021)