Non-clinical medical writing expert

見る: 103

更新日: 22-11-2025

場所: Braine-l’Alleud Walloon Brabant

カテゴリー: 健康/医療

業界: Staffing Recruiting

レベル: Mid-Senior level

ジョブタイプ: Full-time

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仕事内容

You prepare complex documents such as integrated CTD summaries and IBs, ensuring adherence to regulatory requirements and internal standards
You ensure the availability of high-quality SEND datasets as required by regulatory agencies
You serve as an expert in using authoring tools and ensure compliance with our client writing styles and regulatory specifications
You maintain Nonclinical Medical Writing trackers supported by a network of internal and external partners
You proactively identify opportunities for process improvements to enhance compliance and efficiency in submissions

What are we looking for?

You hold a PhD, MSc, or BSc in a relevant pharmaceutical development science
You have over 5 years of experience in a similar role, with a strong awareness of nonclinical study regulatory requirements
You are proficient in standard software (MS Office), and authoring tools (ideally StartingPoint and PleaseReview)
You are an excellent communicator with strong written and verbal skills
You have a thorough understanding of Good Laboratory Practices (GLPs), ICH guidelines, and SEND requirements
You are fluent in English

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