Director, Medical Writing

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 escalate 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 a preference for US-based candidates, particularly on the East Coast. 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.