Medical writing for clinical and regulatory documents
Leadership of medical writing teams and vendors
Knowledge of ich guidelines and gcp
Ipsen is a global biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease, and Neuroscience with a culture of collaboration, excellence, and impact
Job Summary
Ipsen is a global biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease, and Neuroscience with a culture of collaboration, excellence, and impact.
The Senior Medical Writer leads strategy and delivery of high-quality clinical and regulatory documents, ensuring alignment with global standards and fostering excellence across internal and external teams.
The role requires strong leadership, project management, and communication skills to support clinical development and regulatory submissions while promoting continuous improvement and patient focus.
Matching Summary
Ipsen is a global biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease, and Neuroscience with a culture of collaboration, excellence, and impact.
Skills & Requirements
Must-have
Medical writing for clinical and regulatory documents
Leadership of medical writing teams and vendors
Knowledge of ICH guidelines and GCP
Regulatory submission document preparation
Project and resource management
Cross-functional collaboration
Nice-to-have
Innovation in medical writing processes
Coaching and mentoring skills
Strong communication and negotiation
Patient-centric documentation approach
Process improvement and automation
Experience with outsourced writing models
Key Requirements
Minimum 7 years medical writing experience
Bachelor’s degree in Life Sciences (advanced preferred)
Proven leadership managing teams and vendors
Experience with major regulatory submissions (NDA/BLA/MAA)
Strong understanding of global regulatory requirements
Recognised medical writing qualification advantageous