Director, Medical Writing Asset Lead – Oncology

Role Overview

• Lead strategy, planning, authoring and delivery of clinical documents across the asset lifecycle, including clinical study protocols, clinical sections of the IMPD/IND, investigator brochures, clinical study reports, briefing documents for regulatory authorities, Common Technical Document Summaries and Clinical Overview, and responses to regulatory authority questions.
• Own and drive asset-level medical writing strategy, ensuring alignment with development and regulatory objectives across regions
• Lead and coach multi-disciplinary matrix teams and external vendors to meet quality, timeline and budget expectations.
• Plan and deliver complex and accelerated global submissions, recommending innovative approaches to achieve ambitious timelines while proactively managing cross-functional interdependencies and risks.
• Create and maintain submission and document lifecycle plans.
• Advise teams on fit-for-purpose approaches and risk mitigation.
• Act as lead author or senior reviewer for complex submission documents and regulator queries, ensuring clear scientific positioning and compelling regulatory narratives.
• Define and recommend resourcing strategies for major projects, including optimal use of internal teams and external vendors
• Drive process and technology improvements that increase consistency, efficiency and document quality while constructively challenging the status quo.
• Mentor colleagues and build oncology medical writing capability through training, clear feedback and practical guidance, including contribution to training materials.

Requirements

• Postgraduate degree e.g. PhD, PharmD, MSc, MPH, in life sciences, pharmacy, medicine, public health or related discipline
• Significant experience in clinical regulatory medical writing within the pharmaceutical or biotech industry
• Experience in authoring and leading regulatory clinical documents for global oncology FDA and/or EMA submissions
• Experience in leading multi-disciplinary, matrix teams and managing external medical writing vendors
• Experience in program management i.e. project planning and delivery skills, including risk identification and timeline management
• Written and verbal communication skills with the ability to present complex scientific content clearly.

Benefits

• Private healthcare
• Additional paid days off
• Life insurance
• Private pension plan
• Fully paid parental leave & care of family member leave