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Looking for experienced PIP writer for gastroenterology product

  • Regulatory services - CMC writing - medical writing
  • Human Medicines, Biopharmaceuticals
  • Europe
  • 10/15/2012

Description

We need a PIP writer who has experience in gastroenterology, especially Morbus Crohn. A first draft should be ready by end 2012. We require experience with EMA-PDCO procedures in this therapeutic area, including experience in getting the indication/condition strictly limited to our indication of interest.
We also would like to see experience with the FDA rules as we have a US partner with whom we want to prepare the agency paediatric submissions for FDA and EMA in parallel.

Requirements

  • Gastroenterology experience
  • Knowledge on EMA and FDA rules for peadiatric submissions
  • PIP writing experience and PDCO experience

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