Consultant Medical Writer – Regulatory and Clinical Documents

Your new company Are you a seasoned Medical Writer with expert experience of writing Clinical and Regulatory documents? Our client, a global biopharmaceutical powerhouse, is seeking a Consultant Medical Writer to lead strategic and operational excellence across their Oncology portfolio.This is a high-impact, global role offering the chance to influence regulatory strategy at the highest level and join a forward-thinking organisation that values transformation, quality, and scientific integrity. Remote OUTSIDE IR35 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: Oversee 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). Be 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. What you'll need to succeed 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. Exceptional communication, negotiation, and strategic thinking skills. A passion for innovation, including AI-assisted writing and process transformation. 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 Apply tot his job