Director, Medical Writing Asset Lead – Oncology
GSK
full-time
Posted on:
Location Type: Hybrid
Location: Stevenage • Poland
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Job Level
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical writingregulatory submissionsmedical writing strategyproject planningrisk managementdocument lifecycle managementauthoring clinical documentssubmission document reviewscientific positioningoncology
Soft Skills
leadershipcoachingcommunicationmentoringcollaborationproblem-solvingstrategic thinkingadaptabilityfeedback deliverytraining
Certifications
PhDPharmDMScMPH