Rosaline Ademefun
@rosalineademefun
Regulatory Medical Writer delivering submission-ready safety and clinical documentation with QC.
United KingdomWhat I'm looking for
I’m a Regulatory Medical Writer with almost two years of dedicated RMW experience delivering clinical and regulatory documentation across CSR, CTD, Investigator Brochure and clinical protocol document types. At Pfizer, I produce submission-ready sections aligned to ICH E3 and ICH E6 (GCP), with a consistent focus on data traceability, QC-verified accuracy, and clear, regulatory-compliant writing.
Before moving fully into regulatory writing, I built a strong pharmacy and medicines optimisation foundation across primary care, community pharmacy, and ICB-level prescribing governance. As a Senior Medicines Optimisation Pharmacist, I authored prescribing guidelines and clinical policy documents, and led development of annual QIPP programme documentation by translating complex prescribing and efficiency data into stakeholder-ready outputs.
I bring expertise in safety narrative development, clinical guideline writing, scientific literature review, and stakeholder-facing clinical communication. My approach is grounded in scientific data interpretation (efficacy and safety), medicines optimisation, and disciplined regulatory writing standards to ensure documents are accurate, compliant, and easy to review.
Experience
Work history, roles, and key accomplishments
Delivered submission-ready sections of Clinical Study Reports and related regulatory documentation, ensuring scientific accuracy and source-data traceability. Produced patient safety narratives and integrated Module 2.7.4 safety summaries in line with ICH and EMA/MHRA CTD requirements, with QC-verified reviewer comment resolution.
Senior Medicines Optimisation Pharmacist
South East London ICB
Oct 2018 - Present (7 years 9 months)
Authored and maintained prescribing guidelines and clinical policy documents for system-wide implementation, ensuring scientific accuracy, regulatory alignment, and stakeholder clarity. Led QIPP programme documentation and produced evidence-based clinical communications on prescribing performance and budget alignment.
Primary Care Pharmacist
Dulwich Medical Centre
Sep 2015 - Oct 2018 (3 years 1 month)
Reviewed and authorised prescriptions and clinical documentation, interpreting clinical data to support medication changes and referrals with a focus on patient safety. Conducted medication reviews and blood pressure clinics, and used EMIS Web searches to support evidence-based prescribing decisions.
Relief Pharmacist Manager
Lloyds Pharmacy
Aug 2012 - Sep 2015 (3 years 1 month)
Reviewed and dispensed NHS and private prescriptions, performing clinical and legal checks to ensure accuracy and compliance prior to release. Identified clinically significant drug interactions, liaised with GPs to amend prescriptions, and provided evidence-based medication counselling to patients.
Education
Degrees, certifications, and relevant coursework
London South Bank University
NV300 Non-Medical Prescribing, Non-Medical Prescribing
2020 -
Completed NV300 Non-Medical Prescribing at London South Bank University.
University of Portsmouth
Master of Pharmacy (MPharm), Pharmacy
2011 -
Completed a Master of Pharmacy (MPharm) at the University of Portsmouth.
Availability
Location
United KingdomAuthorized to work in
Job categories
Skills
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