ASMA IRFAN

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.

EDUCATION

• MBBS – Rawalpindi Medical College, Pakistan
• MPhil (Physiology) – Quaid-i-Azam University, Islamabad
• PhD (Physiology) – Quaid-i-Azam University, Islamabad

CERTIFICATIONS & REGULATORY TRAINING

• Good Clinical Practice (GCP) – Research & Ethics Focus
• Bioethics in Clinical Research – Global Health Training Network
• COPE: Publication Ethics & Plagiarism
• Research & Proposal Writing – INASP
• Grant Writing – INASP
• Health Metrics & Data Interpretation – GBD (University of Washington)
• Clinical Research Documentation & Scientific Writing Workshops