Interview with Renée Paternoster: A Regulatory Writer’s Perspective

This interview kicks off a new series that focuses on different types of writing that can be done within the larger medical and science writing umbrella. This interview is with Renée Paternoster, whose specialty is regulatory writing.

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Renée is a highly experienced medical writing professional with over 20 years of clinical writing experience in the major pharmaceutical industry and 8 years as a senior-level medical writing consultant. She writes and edits documents across a broad range of therapeutic areas, including oncology, psychiatry, neurology, immunology, pain management, women's health, dermatology, urology, gastroenterology, hemostasis, and cardiovascular, metabolic, and infectious diseases. You can find out more about Renée and the services she offers using this link.


Key Takeaways:

  • 2:04 - What types of documents are included in clinical regulatory writing

  • 5:15 - The career path that most clinical regulatory writers take and the training needed

  • 8:25 - How Renée obtained her first few freelance clients and the main driver of finding new business

  • 12:30 - Project fee vs hourly fee and which is best for regulatory writing

  • 20:00 - Pros and cons of working in-house vs freelancing

  • 23:15 - How to manage client expectations of timelines (and what to do if they are unreasonable)

  • 26:33 - Strengths and characteristics of a good clinical regulatory writer

    • Renée also mentioned after the interview that other positive attributes would include the ability to focus and concentrate for long periods of time, strong interpersonal skills, diplomacy, and a fairly extroverted personality to function well within the matrix team

  • 29:43 - Important questions to ask after you write a document

  • 33:15 - Potential pitfalls of working in regulatory writing

  • 37:40 - One piece of advice for anyone looking to start working in regulatory writing

Jennifer Gregg