Senior Regulatory Content Specialist

Overview We are seeking a skilled Regulatory / Medical Writer to collaborate on strategic and compliant document creation.

Responsibilities Promote regulatory excellence by guiding clients on structure, compliance, and best practices in document authorship.

Lead the review of a diverse range of documents (e.g., CSRs, IBs, PLSs) to ensure alignment with ICH / GxP / GPP standards.

Cultivate strong relationships with client teams, providing scientific and regulatory insight that enhances value beyond document production.

Mentor and work alongside writing teams, leveraging expertise to guarantee accuracy, clarity, and regulatory compliance.

Present the writing function confidently in meetings, workshops, and client interactions.

Requirements A proven background as a medical / regulatory writer within pharmaceutical companies, CROs, or regulatory service providers.

Expertise in regulatory guidelines (ICH, GxP, GPP) and regulated deliverables (CSRs, IBs, PLSs).

Exceptional communication skills, enabling translation of technical writing expertise into consulting services.

A detail-oriented, organized professional who balances writing quality with broader consulting impact.

Experience in scientific communications is beneficial, but regulatory writing expertise is essential.

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