Experienced MBBS-qualified Medical Writer and Clinical Research Leader with over 10 years of hands-on clinical, academic, and regulatory medical writing experience, supporting investigator-initiated trials, randomized controlled studies, and regulatory-aligned research documentation. Proven expertise in clinical study documentation, protocols, investigator brochures, clinical narratives, and publication-ready manuscripts, aligned with FDA, ICH-GCP, and international regulatory standards.
Extensive background working with clinical data, biostatistics teams, ethics committees (IRB/IEC), and journal editors, with a strong ability to translate complex clinical and scientific data into clear, compliant, submission-ready medical content. Experienced in remote collaboration, tight timelines, and U.S.-style regulatory expectations.
CORE MEDICAL WRITING & REGULATORY SKILLS
- Clinical Study Reports (CSR-style Results & Narratives)
- Clinical Trial Protocols & Amendments
- Investigator Brochures (IB-style scientific summaries)
- Clinical Summaries & Safety Narratives
- Regulatory-aligned documents (CTD-style Modules 2 & 5 – content support)
- Manuscripts for peer-reviewed medical journals
- Informed Consent Forms (ICFs)
- Ethics submissions (IRB / IEC documentation)
- FDA, ICH-GCP, EMA-aligned medical writing
- Data interpretation from RCTs, observational studies & cross-sectional trials
PROFESSIONAL EXPERIENCE
Clinical & Regulatory Medical Writer (Remote / Academic–Industry Interface)
2015 – Present | Pakistan (Remote Collaboration)
- Authored and reviewed clinical protocols, amendments, and study documentation for investigator-initiated and institution-based clinical studies.
- Prepared CSR-style results sections, clinical summaries, and patient narratives for randomized controlled trials and observational studies.
- Developed Investigator Brochure-style scientific documents, summarizing pharmacology, safety, and clinical evidence.
- Translated raw clinical, laboratory, and statistical outputs into regulatory-compliant medical content.
- Ensured adherence to ICH-GCP, FDA-aligned documentation standards, and ethical research conduct.
- Collaborated with clinicians, biostatisticians, data analysts, and ethics committees to finalize submission-ready documents.
- Delivered content within strict timelines, mirroring U.S. regulatory expectations.
Chairperson – Institutional Research & Ethical Board (IREB)
Islamabad Medical & Dental College | 2021 – Present
- Led ethical and regulatory review of clinical research protocols, consent documents, and safety reporting.
- Reviewed studies for GCP compliance, patient safety, and regulatory readiness.
- Provided guidance on FDA-style documentation, protocol structure, and reporting standards.
Chief Editor / Editorial Board Member (Medical Journals)
2019 – Present
- Reviewed and edited clinical manuscripts, study reports, and regulatory-style submissions.
- Ensured compliance with international publication ethics (COPE) and reporting standards.
- Mentored authors on structured medical writing, clarity, and regulatory tone.
