Your new company
Are you a seasoned Medical Writing leader ready to shape the future of oncology drug development? Our client, a global biopharmaceutical powerhouse, is seeking a Director of Medical Writing to lead strategic and operational excellence across their Oncology portfolio.This is a high-impact, global role offering the chance to drive innovation, lead talented teams, and influence regulatory strategy at the highest level.
You'll be joining a forward-thinking organisation that values transformation, quality, and scientific integrity.
Work with a mission-driven organisation making a real impact in oncology.
Be part of a global leadership team shaping the future of medical writing.
Enjoy a flexible working model with hybrid or remote options.
Your new role
As Director, Medical Writing, you'll be the go-to expert for all medical writing activities within the Oncology Therapeutic Area. You'll:
Lead and inspire a team of Senior Medical Writers and Managers across global hubs.
Develop and execute TA-specific medical writing roadmaps aligned with R&D priorities.
Oversee and provide input on all documents for clinical development from FIH through Phase 3 and Regulatory submissions including regulatory interactions with agencies (e.g., pre-IND, End of Phase 2, End of Phase 3, Type C meetings).
Highly organised, proactive, respects metrics-driven timelines and accountability for quality.
Ensure consistency and compliance across the therapeutic area documents (protocols through marketing applications).
Drive regulatory storytelling and key message generation for critical submissions.
Ensure quality, consistency, and compliance across all deliverables.
Manage outsourced writing models and vendor relationships.Provide dashboards and performance insights to senior leadership.
What you'll need to succeed
We're looking for a visionary leader with:
Proven experience in medical writing leadership within oncology or a related TA.
Expert experience of writing documents for clinical development from FIH through Phase 3 and Regulatory submissions including regulatory interactions with agencies (e.g., pre-IND, End of Phase 2, End of Phase 3, Type C meetings).
Deep understanding of global regulatory requirements and submission strategy.Strong background in clinical development and cross-functional collaboration.
Experience managing remote and outsourced teams.
Exceptional communication, negotiation, and strategic thinking skills.
A passion for innovation, including AI-assisted writing and process transformation.
Key Skills & Competencies
Expert experience of writing documents for clinical development from FIH through Phase 3 and Regulatory submissions including regulatory interactions with agencies (e.g., pre-IND, End of Phase 2, End of Phase 3, Type C meetings).
Executive leadership & change advocacy
High-stakes negotiation & stakeholder management
Talent development & succession planning
Forecasting, budgeting & resource management
Cross-cultural team leadership
Process improvement & SOP development
What you need to do now
Before you apply for this position, it is vital that you are in possession of a UK passport or relevant visa to work without restrictions in the UK and residing in the UK.
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call Roberta Atkins on 03330106292