Head of Medical Writing and Regulatory Affairs – Leading a European Team | Mid-Sized CRO

Location: Remote (Europe)

Are you a seasoned Medical Writing leader ready to take on a high-impact role? Our client, a mid-sized, dynamic CRO, is seeking a Head of Medical Writing and Regulatory Affairs to lead and mentor a team of medical writers across Europe. This is a fantastic opportunity to drive excellence in medical writing and regulatory affairs, working closely with biopharma sponsors on critical projects.

Key Responsibilities:

• Leadership & Strategy – Oversee and develop a team of medical writers, ensuring high-quality regulatory and scientific documents.
• Regulatory & Compliance – Take ownership of medical writing deliverables, ensuring compliance with industry guidelines (ICH, EMA, FDA).
• Client Engagement – Partner with biopharma sponsors, offering strategic insights and ensuring seamless communication.
• Process Improvement – Develop best practices, training, and standard operating procedures to enhance efficiency and consistency.

Requirements:

• Proven experience in medical writing within a CRO, pharma, or biotech environment.
• Strong leadership skills, with prior experience managing teams.
• Expertise in regulatory writing, including clinical study reports, investigator brochures, and submission dossiers.
• Deep understanding of ICH, EMA, FDA regulatory requirements.
• Excellent stakeholder management and communication skills.

What’s on Offer?

• A leadership role with the autonomy to shape the medical writing function.
• The opportunity to work with innovative biopharma sponsors on cutting-edge projects.
• A flexible, remote-first position with occasional travel.
• Competitive salary and benefits package.