Director, Medical Writing Asset Lead – Oncology
GSK
full-time
Posted on:
Location Type: Hybrid
Location: Wavre • Poland
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Job Level
About the role
- Lead strategy, planning, authoring and delivery of clinical documents across the asset lifecycle
- 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
- 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
- Define and recommend resourcing strategies for major projects
Requirements
- Postgraduate degree e.g. PhD, PharmD, MSc, MPH, in life sciences, pharmacy, medicine, public health or related discipline
- Minimum 10 years’ experience in clinical regulatory medical writing within the pharmaceutical or biotech industry
- Experience in oncology
- Experience in authoring and leading regulatory clinical documents for global 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