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Regulatory writing consultant

Mantova
TransPerfect Life Sciences
Pubblicato il Pubblicato 14h fa
Descrizione

PWe are looking for an experienced Regulatory/Medical Writer who is ready to step into a more consultative, client-facing role. While you’ll bring deep hands-on expertise in regulatory document authorship, this position is focused less on day-to-day writing and more on guiding clients, providing best-practice recommendations, and ensuring the strategic and compliant delivery of high-quality regulatory documents. /ppWhat you’ll do /pulliAct as a trusted advisor to clients on regulatory writing deliverables, offering guidance on structure, compliance, and best practices. /liliOversee and review a broad range of documents (e.g., CSRs, IBs, PLSs) to ensure alignment with ICH/GxP/GPP standards. /liliPartner closely with client teams, offering scientific and regulatory insight that adds value beyond document production. /liliMentor and collaborate with writing teams, leveraging your background to ensure accuracy, clarity, and regulatory compliance. /liliRepresent the writing function confidently in meetings, workshops, and client interactions. /li /ulpWhat we’re looking for /pulliStrong background as a medical/regulatory writer within pharmaceutical companies, CROs, or regulatory service providers. /liliProven familiarity with regulatory guidelines (ICH, GxP, GPP) and regulated deliverables (CSRs, IBs, PLSs). /liliExcellent communication skills, with the ability to translate technical writing expertise into client-facing consulting. /liliA detail-oriented, organized professional who can balance writing quality with broader consulting impact. /liliExperience in scientific communications a plus, but regulatory writing expertise is essential. /li /ulpWhy join us? /ppThis is a unique opportunity for a writer who wants to evolve into a strategic, consultative role. You’ll still leverage your writing background every day, but instead of focusing on drafting, you’ll guide clients, shape deliverables, and influence best practices in regulatory writing. /p

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