Director, Medical Writing

Agomab; Antwerpen; Remote; EUR 100,000 - 180,000; Full time

Benefits offered by this job

Remote flexibility

Travel opportunities

Competitive salary

Job summary

Agomab seeks a Director of Medical Writing to lead narrative strategy, document quality, and cross-functional collaboration across clinical programs. The role oversees CRO medical writers, develops scalable processes, and guides AI-assisted tools with strong controls for oversight and confidentiality.

The position combines hands-on document development with strategic partnership to shape writing standards, tools, and submission-ready content across Phase 1–3 programs.

Qualifications

• Bachelor's degree in life sciences; an MS/PhD preferred.
• 10+ years regulatory medical writing in pharma/biotech with independent authorship of Phase 1–3 documents.
• Strong experience with protocols, CSRs, IBs, and regulatory agency briefing docs.
• Experience leading IND/CTA and eCTD supporting documents, CTD Module 2/5 summaries.
• Knowledge of global regulatory requirements and disclosure rules.
• Hands-on with AI-assisted tools in medical writing or regulatory settings.
• Ability to lead cross-functional initiatives and manage deadlines.

Responsibilities

• Lead authorship and narrative strategy for clinical/regulatory documents.
• Oversee CROs and external writers; ensure timely deliverables.
• Develop and maintain medical writing standards, templates, and SOPs.
• Pilot AI-assisted workflows with controls for risk, traceability and quality.
• Collaborate with Regulatory Affairs, Clinical Development, Biostatistics, and Pharmacovigilance.

Skills

Medical writing leadership

Regulatory writing

Project management

CRO management

AI in medical writing

Cross-functional collaboration

ICH E3 knowledge

CTD/eCTD familiarity

Education

Bachelor in life sciences

MS/PhD preferred

Tools

Veeva Vault

Please Review

CTD/eCTD standards

Job description

Director, Medical Writing

Department: Clinical Development

Employment Type: Permanent - Full Time

Location: Agomab All Sites

Description

The Director Medical Writing will lead narrative strategy and document quality across clinical programs, oversee CRO medical writers, and build scalable processes for the pipeline's progression into Phase 3. The role will also lead AI-assisted tools and workflows, establishing appropriate controls for human oversight, traceability, accuracy, confidentiality, validation, and quality.

This hands-on leadership role combines document development with strategic cross-functional partnership. The Director will shape how documents communicate the program story and help define Agomab's medical writing standards, processes, and tools.

Key Responsibilities

• Document authorship and narrative strategy
  • Lead the authorship and narrative strategy of clinical and regulatory documents, including protocols, study reports, investigator's brochures, agency briefing packages, and pediatric plans.
  • Author and edit IND/NDA/eCTD content, including CTD Module 2/5 summaries, clinical overviews, and integrated safety and efficacy summaries.
  • Ensure documents are clear, scientifically accurate, consistent, compliant, and submission-ready.
• Documentation standards and process ownership
  • Develop and maintain medical writing standards, templates, SOPs, style guidance, training, and resources.
  • Keep practices aligned with current ICH, FDA, EMA, CTD/eCTD, and disclosure requirements.
  • Use quality, cycle-time, and efficiency metrics to improve documentation processes and collaboration.
• CRO and external medical writing management
  • Plan medical writing resources and recommend the right mix of internal and external support.
  • Select, brief, oversee, and quality-check CROs and external writers.
  • Manage external deliverables against program milestones and submission timelines.
• AI and Technology
  • Evaluate, pilot, and implement AI-assisted and automation use cases for medical writing.
  • Establish controls for risk, human oversight, source traceability, verification, confidentiality, validation, change management, and quality.
  • Develop approved workflows, reusable prompts, and practical training that support responsible adoption.
• Cross-functional collaboration and planning
  • Partner with Regulatory Affairs, Clinical Development, Clinical Operations, Biostatistics, Pharmacovigilance, and other stakeholders.
  • Plan documents, coordinate inputs and review cycles, resolve issues, and drive timely completion.
  • Contribute to the scaling of medical writing through capacity planning and effective resourcing models.

Skills, Knowledge and Expertise

• Bachelor's degree in a life science, medical, or related discipline; an MS, PharmD, or PhD is preferred.
• At least 10 years of regulatory medical writing experience in the pharmaceutical or biopharmaceutical industry, including independent authorship of Phase 1-3 documents.
• Strong direct experience with protocols, clinical study reports (ICH E3), investigator's brochures, and regulatory agency briefing documents.
• Experience authoring or leading IND/CTA and eCTD supporting documents, including CTD Module 2/5 summaries and integrated safety and efficacy summaries.
• Thorough knowledge of global regulatory requirements, CTD/eCTD standards, disclosure requirements, drug development, and clinical trial processes.
• Hands‑on experience evaluating, implementing, or governing AI‑assisted or automation tools in a medical writing or regulatory setting.
• Ability to lead cross‑functional initiatives, manage multiple programs and deadlines, work independently, exercise sound judgement, and escalation appropriately.
• Clear, collaborative communication skills and experience partnering with Regulatory Affairs, Clinical Development, Clinical Operations, Biostatistics, and Pharmacovigilance.
• Preferred: experience in GI or respiratory indications, inflammation or fibrosis; CRO oversight; Veeva Vault, Please Review, or equivalent; pediatric plans; publications; or an early‑stage biotech environment.

What we offer

• The role may be based in the US or EU, with an East Coast US location considered a plus. Remote and flexible working, with periodic travel to Belgium, Boston, and key program meetings.
• A high‑impact role in an ambitious, innovation‑driven biotech company.
• Direct involvement in pioneering therapies for unmet medical needs.
• A collaborative, agile and fast‑paced environment.
• Competitive salary and benefits.