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Beyond Writing: How Senior Medical Writers Add Strategic Value Throughout Clinical Development and Regulatory Submission
Who it is for
Open to EMWA members registered for the EMWA Autumn Conference 2026.
What it covers
Medical writing has evolved substantially over the last decade. While high-quality document preparation remains a core responsibility, experienced medical writers are increasingly expected to contribute strategically across the clinical development lifecycle. Medical writers now participate in protocol design discussions, evidence interpretation, submission planning, health authority readiness, cross-functional alignment, and quality oversight. Despite this evolution, many organizations continue to view medical writing primarily as a document production function rather than a strategic scientific discipline.
This session aims to demonstrate how medical writers can expand their influence beyond document authoring and become strategic contributors to clinical development and regulatory success. Participants will gain practical insights into how senior writers support decision-making, manage complex stakeholder environments, and improve submission quality and efficiency.
Dr. Ozan Batigun is a Senior/Lead Medical Writer, physician, and regulatory strategy consultant with more than 10 years of experience in clinical development, regulatory writing, and scientific communications. He has authored and led the development of a broad range of regulatory and clinical documents, including Clinical Study Reports (CSRs), Investigator's Brochures (IBs), clinical protocols, CTD Modules 2.5 and 2.7, safety documents, and medical device clinical evaluation reports.
Throughout his career, Dr. Batigün has collaborated with leading global pharmaceutical organizations, including Pfizer, Roche, Abbott, Teva, and Novo Nordisk-supported programs. His expertise spans regulatory submissions for Phase II-IV clinical studies, medical writing leadership, cross-functional team management, and mentoring of medical writers. He has authored more than 50 Clinical Study Reports, numerous Investigator's Brochures and protocols, and multiple regulatory submission documents supporting global development programs.
In addition to his medical writing career, Dr. Batigün has held leadership roles in the pharmaceutical industry, including positions at Pfizer, Roche, Abbott, and Teva, providing him with extensive experience in medical affairs, market access, regulatory strategy, and scientific
communications. He currently serves as Managing Partner at QA Executive Consultancy, where he provides consulting, training, and strategic guidance in clinical research, regulatory affairs, and medical writing.
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Registration fee first
The conference registration fee (€50) must be in your basket before any session can be added. It is one off and covers the opening session and the plenary.
Terms and conditions
Changes to registration
Changes may be made to workshop or seminar choices after booking (that is, a cancellation of one workshop or seminar choice and replacement by another), for an administrative fee of €27, plus any difference in price between the choice of workshops or seminars. Workshops, seminars and lunchtime sponsored sessions may be added to your original registration (subject to availability) at any time, without an administrative fee by contacting info@emwa.org. All changes are subject to availability.
Cancellation of attendance
If you wish to cancel your attendance at the conference, a refund, minus an administration fee of €162, will be made provided your cancellation is made in writing to EMWA head office before 20 October 2026. No refunds will be made after this date.
Payments
Invoices must be settled by bank transfer in Euro, or paid by card through Stripe. All fees are payable in advance. Full payment is due by 30 October 2026. If payment has not been received, EMWA reserves the right to request payment and cancel registration.