Senior Regulatory / Medical Writing Consultant

About the Role

We seek a seasoned Regulatory / Medical Writer to transition into a more consultative, client-facing position.

Main Responsibilities

• Act as a trusted advisor to clients on regulatory writing deliverables, offering guidance on structure, compliance, and best practices.
• Collaborate closely with client teams, providing scientific and regulatory insight that adds value beyond document production.
• Mentor and work with writing teams, leveraging your background to ensure accuracy, clarity, and regulatory compliance.
• Present the writing function confidently in meetings, workshops, and client interactions.

A strong background as a medical / regulatory writer within pharmaceutical companies, CROs, or regulatory service providers is essential. Proven familiarity with regulatory guidelines (ICH, GxP, GPP) and regulated deliverables (CSRs, IBs, PLSs) is required. Excellent communication skills, with the ability to translate technical writing expertise into client-facing consulting, are necessary. A detail-oriented, organized professional who can balance writing quality with broader consulting impact will thrive in this role. Experience in scientific communications is a plus, but regulatory writing expertise is essential.

The Ideal Candidate

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