DIRECTOR MEDICAL WRITING EU

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

Director, Medical Writing EU

Help shape the medical writing standards, processes and tools that support the progression of clinical programmes. This hands‑on leadership role offers the opportunity to combine clinical document authorship, cross‑functional partnership, CRO oversight and taking the lead on AI tool review and implementation.

Location: n/a,

Category: Medical Writing

Country: Remote - Europe

Employment: Direct Hire/Perm

Worksite: Hybrid

Job Description

Overview

You will lead narrative strategy and document quality across clinical programmes, ensuring clear, scientifically accurate, compliant and submission‑ready content. You will work closely with Regulatory Affairs, Clinical Development, Clinical Operations, Biostatistics and Pharmacovigilance.

Key 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.

Must‑Have

• Bachelor’s degree in a life science, medical or related discipline.
• At least 10 years’ regulatory medical writing experience in the pharmaceutical or biopharmaceutical industry.
• Independent authorship of Phase 1‑3 documents, including protocols, clinical study reports, investigator’s brochures and regulatory briefing documents.
• 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 a regulatory setting.
• Experience leading cross‑functional initiatives and managing multiple deadlines.
• Based in Benelux, Spain or Italy

Nice‑to‑Have

• MS, PharmD or PhD.
• People management experience.
• Familiarity with Veeva Vault
• Experience in a growing biotech would be advantageous

Equal Opportunity Employer

We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.