Medical Writing

Medical Writing – From Complexity, to Clarity

  • News
  • Read time: 7 minutes

A little bit of art can elevate great science – let our team of experienced Medical Writers make the complex clear.

Turning complex science into clear, compelling documents is crucial – especially when busy regulatory reviewers are your audience. With clear writing, sharp reasoning, and a logical flow, we help your documents get read, understood – and approved.

At LINK Medical, we work as an extension of your team – whether you are presenting results from an ophthalmology trial or introducing a new cancer therapy, we are here to get it right, together.

Meet our Medical Writing Team

Medical writing

Jennifer Honek
Senior Medical Writer (Sr MW)

Jennifer holds a PhD in Medical Sciences and has extensive experience in medical writing, regulatory affairs, and quality assurance. She has worked as a consultant and in small Biotech/MedTech companies and CROs, covering pharmaceuticals and medical devices across various therapeutic areas. Jennifer has been a Medical Writer since 2015 and joined LINK Medical in 2021.

Medical Writing OP 1

Why Hire Medical Writers from LINK Medical?

  • Collaboration with internal expert teams – Project Management, Biostatistics, Medical Devices, Real World Research and Safety.
  • Supporting the entire product lifecycle – from scientific advice to protocol development, study reporting to post-marketing support.

Competencies & Services

  • Experience in: First-in-human trials, Phase I - IV, Post-marketing, Real World Research (RWR), Medical Devices, Advanced Therapy Medicinal Products (ATMPs)
  • Study synopsis and Protocol development
  • Clinical Study Report (incl. safety narratives) & Clinical Investigation Report
  • Patient information and Informed Consent Form
  • Clinical and Performance Evaluation Plan and Report
  • Clinical Performance Study Protocol and Report (for in vitro diagnostic devices)
  • Literature reviews (incl. State-of-the-Art for Medical Devices)
  • Study registration and reporting (e.g., EudraCT, CTIS, clinicaltrials.gov)
  • Investigator’s Brochure & Investigational Medicinal Product Dossier
  • Scientific advice requests (e.g., to EMA, BfArM, MHRA), including Briefing Book
  • Development Safety Update Report & Periodic Benefit-Risk Evaluation Report
  • Investigational New Drug Annual Report
  • Manuscripts and publication support

Get in touch – and let us help shine a clear light on your project:
info@linkmedical.eu

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