Medical Writing Operational & Scientific Lead - Madrid

Overview

We are seeking a hands-on Medical Writing Lead to own and operationalise our growing medical writing business. This is not a purely supervisory role; you’ll be a do-er who can both run the business day-to-day and represent our expertise in client engagements. You will define processes, drive operational excellence, and lend deep subject matter knowledge to ensure quality, credibility, and growth across regulatory, clinical, and commercial projects.

Key Responsibilities

• Operational Leadership: Build and refine workflows, SOPs, tools, and best practices to scale the medical writing function efficiently. Partner with project managers to streamline delivery, resource allocation, and quality control.

• Subject Matter Expertise: Provide scientific and regulatory insight across deliverables (eg, protocols, CSRs, publications, PLSs, and training materials).

• Hands-On Writing & Review: Review key documents when needed, ensuring high-quality, compliant, and client-ready outputs.

• Client-Facing Partner: Serve as a trusted advisor in scoping discussions and client meetings, adding credibility and shaping strategic solutions.

• Team Development: Mentor and guide writers and freelancers on best practices and industry guidance.

• Business Ownership: Collaborate with leadership on forecasting, resourcing, and capability development to grow the writing offering.

Experience & Skills

• Experience: 7/10+ years in medical/regulatory writing within pharma, CRO, or life sciences service providers, with exposure to regulatory and clinical projects.

• Track Record: Proven ability to operationalise a service or function.

• Scientific Credentials: Advanced degree (PhD, PharmD, MD, or MSc) preferred.

• Versatility: Strong regulatory and industry knowledge (ICH, GxP, ICMJE, GPP) and broad familiarity with clinical and med comms deliverables.

• Tech-Savvy Mindset: Comfortable adopting and leveraging technology (eg, content management systems and AI-assisted writing tools) to drive efficiency, quality, and innovation in medical writing workflows.

• Client Skills: Exceptional communication and consulting ability; comfortable leading discussions and representing expertise externally.

• Mindset: Proactive, organised, and execution-driven; someone who thrives on ownership and is as comfortable building processes as they are writing.

Why Join Us

This is a rare opportunity to shape and own a medical writing service line within a global organisation. You’ll blend operational leadership with scientific excellence, directly influencing quality, client satisfaction, and business growth while maintaining your writing craft and credibility in the field.