How can a medical writer help you?
What do you think of when you hear the term "medical writer"?
Is it someone who helps with writing publications? Is it someone who takes minutes at meetings? Is it someone who makes your documents look and sound nice?
Yes, medical writers are all those things - but also so much more!
Did you know that many of us are scientists, pharmacists, nurses and pharmaceutical industry insiders? Like you, we are professionals dedicated to providing access to innovative treatments.
When you hire an experienced medical writer, they can:
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Produce clear, concise, visually appealing and scientifically sound materials
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Ensure compliance of your documents with regulatory and industry standards
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Target writing style to your audience from technical to plain language
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Maintain consistency in messaging across your documents, platforms and departments
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Liaise with other professionals, like study investigators, statisticians and CROs on your behalf
When you hire a medical writer, you are getting so much more than just writing help!
Let's look at some tasks an experienced medical writer can do for a CSR and a manuscript:
Hi! I'm Mariana Thomson, an independent medical writer specializing in regulatory and clinical documents.
I have a PhD from the University of Toronto (Immunology) and a medical writer certification from the American Medical Writers Association (MWC ).
I created Intellimmune with a vision to provide personalized, high-quality medical writing support that goes beyond just writing documents. I am a capable project manager and I strive to work closely with my clients' teams (eg, regulatory affairs, clinical development, data analysis). Additionally, I developed a network of experienced medical writers, editors, designers, and regulatory consultants who help me provide more than just medical writing services.
At heart, I am a scientist with a passion for language. I currently live and work in Toronto, Canada.
I'd love to hear from you and see how I can help!
I specialize in producing clinical and regulatory documentation, providing precise, clear and targeted medical communications that comply with regulatory and industry standards.
+ Protocols (Phase 1-4)
+ Clinical study reports
+ Investigator's brochures
+ Patient narratives
+ Informed consent forms
+ Agency meeting documents
+ IND/NDA/BLA/MAA submissions
+ Patient Information Sheets
+ DSURs/PSURs
+ Communications with regulatory agencies
+ Pediatric plans
Nearly 20 years of experience with regulatory and clinical documentation.
Full compliance, data and quality check, including language and format check, on all documents.
Experience with documentation for the FDA, EMA, Health Canada, MHRA (UK), PMDA (Japan)
and NPMA (China).
Click here to learn about additional medical writing services provided.
My expertise spans a broad range of therapeutic areas and treatment modalities. My familiarity with many key indications ensures efficiency and expediency in producing your documents.
Click here to see the full list of therapeutic areas I've worked in.
+ Oncology
+ Hematology
+ Neurology
+ Rheumatology
+ Dermatology
+ Psychiatric disorders
+ Immune disorders
+ Cardiology
+ Transplantation
+ mRNA therapies
+ Radioligand therapies
+ Infectious diseases
+ Metabolic disorders
+ mRNA vaccines