Senior Director

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.If you are an experienced medical writing professional looking for your next challenge in a growing, collaborative CRO, we’d love to hear from you.Apply now or reach out for a confidential discussion!