Senior Regulatory Content Specialist

beBeeRegulatory; Bilbao; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A pharmaceutical regulatory consulting firm in Bilbao seeks a skilled Regulatory / Medical Writer to enhance document compliance and promote regulatory excellence. The role involves guiding clients, leading document reviews, and mentoring writing teams. Ideal candidates possess a robust regulatory writing background and exceptional communication skills, balancing writing quality with consulting impact.

Formación

• Proven background as a medical/regulatory writer within pharmaceutical companies.
• Expertise in regulatory guidelines (ICH, GxP, GPP) and deliverables.
• Exceptional communication skills for consulting services.

Responsabilidades

• Guide clients on compliance and best practices in document authorship.
• Lead reviews of regulatory documents ensuring alignment with standards.
• Mentor writing teams to ensure accuracy and clarity.

Conocimientos

Regulatory writing

Document compliance

Scientific communication

Client relationship management

Descripción del empleo

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.