Director, Medical Writing EU — Lead Regulatory Docs & AI

Planet Pharma; Albuquerque (NM); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Planet Pharma is seeking a Director of Medical Writing (EU) to lead narrative strategy and document quality across clinical programmes. You will drive standards, collaborate with Regulatory Affairs and Clinical Development, and oversee CROs and external writers for timely, compliant submission-ready content.

The role involves hands-on authorship of regulatory documents, coordination across multiple functions, and implementing AI-assisted tools to enhance efficiency, while ensuring governance and

Qualifications

• Bachelor’s degree in a life science, medical or related discipline.
• 10+ years of regulatory medical writing experience in the pharmaceutical or biopharmaceutical industry.
• Independent authorship of Phase 1‑3 documents including protocols and clinical study reports.
• Experience with IND/CTA and eCTD supporting documents, including CTD Module 2/5 summaries.
• Strong knowledge of global regulatory requirements, CTD/eCTD standards, disclosure requirements and clinical trial processes.
• Hands-on experience evaluating, implementing or governing AI-assisted or automation tools in medical writing or regulatory settings.
• Experience leading cross-functional initiatives and managing multiple deadlines.
• Based in Benelux, Spain or Italy.

Responsibilities

• Lead and author clinical and regulatory documents, including protocols, clinical study reports, investigator’s brochures, agency briefing packages and paediatric plans.
• Author and edit IND/NDA/eCTD content, including CTD Module 2/5 summaries and integrated safety and efficacy summaries.
• Develop and maintain medical writing standards, templates, SOPs, style guidance, training and resources.
• Select, brief, oversee and quality-check CROs and external writers, managing deliverables against programme milestones.
• Evaluate, pilot and implement AI-assisted and automation tools for medical writing.
• Establish appropriate controls for human oversight, traceability, verification, confidentiality, validation and quality.
• Coordinate cross-functional inputs, review cycles and document completion.
• Use quality, cycle-time and efficiency metrics to improve processes and collaboration.

Skills

Regulatory medical writing

Cross-functional collaboration

CRO oversight

Team leadership

AI tool evaluation

Education

Bachelor's degree in life science

MS, PharmD or PhD

Tools

Veeva Vault

Job description

Planet Pharma is seeking a Director of Medical Writing (EU) to lead narrative strategy and document quality across clinical programmes. You will drive standards, collaborate with Regulatory Affairs and Clinical Development, and oversee CROs and external writers for timely, compliant submission-ready content.

The role involves hands-on authorship of regulatory documents, coordination across multiple functions, and implementing AI-assisted tools to enhance efficiency, while ensuring governance and