Job Description
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
1. Strong background as a medical/regulatory writer within pharmaceutical companies, CROs, or regulatory service providers.
2. Proven familiarity with regulatory...