Leads medical affairs for a neurovascular MedTech portfolio, with responsibility for medical governance, clinical-study safety review, evidence generation, scientific communication, and stakeholder support.
About this role
The role is part of Document Publishing Solutions (DPS), a global team supporting regulatory submissions. It partners with Medical Writing and cross-functional stakeholders to deliver compliant, submission-ready clinical study reports, dossiers, protocols and related documents. It manages publishing and document-management workflows against regulatory standards, internal procedures and submission requirements. Work includes formatting, hyperlinking, bookmarking, validation and publishing, plus oversight of external providers to ensure quality, efficiency and timely delivery. The specialist also supports digital transformation by evaluating, implementing and supporting technologies, including AI-enabled solutions, to improve efficiency and document quality and promote knowledge sharing. Required experience is in document processing, publishing, information management, business systems or related operational support in pharmaceutical, healthcare, technology or another regulated industry. Candidates also need advanced proficiency in Microsoft Word and other Microsoft 365 applications, strong digital literacy, and proven ability to manage vendor relationships and oversee outsourced publishing.
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