

Peter Takacs, M.D.

Physician & Medical Writer
My Story
I’m a physician, medical director, and lead medical writer with over 15 years of experience helping research teams, biopharma companies, and academic investigators bring complex science to life. My career has taken me from writing regulatory submissions that drive global drug approvals to publishing in top-tier journals like The Lancet, NEJM, and Nature.
What I’ve learned along the way is simple: good science only makes an impact if it’s communicated clearly. I specialize in bridging that gap by translating dense clinical data, statistical outputs, and biomarker findings into narratives that regulators, clinicians, and patients can actually use.
I’ve worked across oncology, rare disease, cardiology, gastroenterology, and endocrinology (among others). My experience spans regulatory submissions (IND, NDA, BLA, MAA), Clinical Study Reports, Investigator’s Brochures, and CTD modules, as well as real-world evidence studies and medical affairs projects like advisory boards and scientific platforms. I’ve also mentored writing teams, streamlined publication planning for dozens of clinical programs, and partnered with global pharma companies on high-stakes submissions.
Whether it’s a briefing document for a health authority meeting or a manuscript for a high-impact journal, my focus is always the same: clarity, precision, and strategy. If your team needs writing that stands up to regulatory scrutiny, earns peer recognition, and moves programs forward, that’s where I can help.
How can I help you?
I provide reliable, high-quality medical writing support, ensuring timely delivery and seamless collaboration. Drawing on over a decade in the healthcare sector, I apply scientific knowledge and refined writing skills to optimize your communications.
From professional and lay articles to comprehensive education materials and scientific summaries, I am equipped to handle a wide range of content needs. Contact me to discuss your project requirements, big or small.
