Overview
We 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.
What you’ll do
* Act as a trusted advisor to clients on regulatory writing deliverables, offering guidance on structure, compliance, and best practices.
* Oversee and review a broad range of documents (e.g., CSRs, IBs, PLSs) to ensure alignment with ICH / GxP / GPP standards.
* Partner closely with client teams, offering scientific and regulatory insight that adds value beyond document production.
* Mentor and collaborate with writing teams, leveraging your background to ensure accuracy, clarity, and regulatory compliance.
* Represent the writing function confidently in meetings, workshops, and client interactions.
What we’re looking for
* Strong background as a medical / regulatory writer within pharmaceutical companies, CROs, or regulatory service providers.
* Proven familiarity with regulatory guidelines (ICH, GxP, GPP) and regulated deliverables (CSRs, IBs, PLSs).
* Excellent communication skills, with the ability to translate technical writing expertise into client-facing consulting.
* A detail-oriented, organized professional who can balance writing quality with broader consulting impact.
* Experience in scientific communications a plus, but regulatory writing expertise is essential.
Why join us?
This 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.
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