Medical Writer for Regulatory Affairs

1 day ago


Hørsholm, Hørsholm Kommune, Denmark ALK-Abelló, AS Full time

About Us

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ALK-Abelló, A,S is a pharmaceutical company dedicated to improving the lives of people affected by allergies.

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The Role

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We are seeking a Medical Writer to join our Clinical Reporting department, where you will work closely with key stakeholders to develop and implement clinical disclosure strategies.

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Your Key Responsibilities

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  • Create high-quality documents, including protocols, investigator brochures, clinical study reports, and briefing packages.\
  • Collaborate with cross-functional teams to ensure alignment and effective implementation of clinical disclosure activities.\
  • Stay up-to-date with clinical disclosure legislation and regulations, identifying areas for process improvement and driving change within Global Clinical Development.\
  • Communicate complex data and information to various stakeholders, including senior management and external partners.\
  • Contribute to the development of manuscripts for peer-reviewed journals and other publications.\\
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Requirements

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To succeed in this role, you will need:

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  • A relevant university degree in the natural sciences (PhD, M.Sc., or equivalent).\
  • Proven experience in medical/regulatory writing, with a strong understanding of the clinical development value chain.\
  • Experience with clinical disclosure activities and a demonstrated ability to adapt to changing requirements.\
  • Strong communication and collaboration skills, with the ability to build relationships with cross-functional teams and external partners.\
  • Excellent writing and analytical skills, with fluency in written and spoken English.\\
    • ],


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