Regulatory Writing Consultant

TransPerfect Life Sciences; Napoli; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading language services provider in Naples is seeking an experienced Regulatory / Medical Writer. This strategic role focuses on guiding clients in regulatory writing rather than daily drafting. Candidates should have a background in medical writing, excellent communication skills, and familiarity with regulatory guidelines. This position offers a unique opportunity to shape deliverables and influence best practices while still leveraging writing expertise.

Competenze

• Proven background as a medical/regulatory writer in pharmaceutical settings.
• Familiar with ICH, GxP, GPP regulatory guidelines.
• Ability to provide consulting in a client-facing role.

Mansioni

• Advise clients on regulatory writing best practices.
• Review documents to ensure regulatory compliance.
• Mentor writing teams and ensure quality deliverables.

Conoscenze

Regulatory writing expertise

Client-facing consulting

Excellent communication skills

Detail-oriented

Descrizione del lavoro

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.

Overview

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.

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.