Head of Medical Writing (m­­/­­f­­/­­d)

Establish medical and regulatory writing best practices (templates, SOPs, work instructions, document review, document timelines) to ensure consistency and quality of documents Lead writing team to ensure the generation of key documents in internal clinical partnerships with relevant functions (Project Management, Data Management and CRAs) on schedule and the support of key documents in Artivion partnerships with relevant functions (Regulatory Affairs, Quality, R&D and Sales & Marketing) Strategic and timely completion of key documents such as clinical study protocols, clinical study reports, responses to information requests from regulatory agencies, and major regulatory submissions Support MDR submissions on time with the accurate completion of CERs, and other post market activities Coordinate document writing, review, and revision to ensure the highest quality in conformity with program strategy and objectives Proactively plan future deliverables to ensure organizational alignment and preparation for document reviews in an efficient manner Oversight of medical and regulatory writing vendors in alignment with global internal resources, methods, SOPs, and overall approach