It's a good feeling to know you're doing your best with purpose every day. At Artivion, we manufacture high-quality products and solutions for the treatment of aortic diseases. Together with surgeons worldwide, we save lives. In doing so, we rely on the strengths of each and every employee. Your strength counts, too : As an important link in the chain, you make a contribution to saving lives together with us. Contribute your strengths and let us grow together.We are hiringHEAD OF MEDICAL WRITING m / f / dYour strength : Degree in medicine or natural scienceLong-standing years of experience as a medical writer in the medical / biomedical industry with evidence of increasing responsibility and technical developmentProficient at writing protocols, manuscripts and study reportsAptitude for compilation, analysis, and presentation of dataAbility to communicate fluently and effectively, both in writing and verballyKnowledge of ICH and GCP guidelines and any other regulations relevant to medical writingCompetency to effectively manage and motivate teams to achieve corporate, departmental and program goals on timeEfficiency in managing and motivating direct reports to maximize writers' contributions and career developmentFamiliarity with medical devices, MDD and MDRAccomplished use of MS Word, PowerPoint and Adobe AcrobatProficiency in written and spoken EnglishPractice in managing medical writers preferredYour contribution : Establish medical and regulatory writing best practices (templates, SOPs, work instructions, document review, document timelines) to ensure consistency and quality of documentsLead 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 submissionsSupport MDR submissions on time with the accurate completion of CERs, and other post market activitiesCoordinate document writing, review, and revision to ensure the highest quality in conformity with program strategy and objectivesProactively plan future deliverables to ensure organizational alignment and preparation for document reviews in an efficient mannerOversight of medical and regulatory writing vendors in alignment with global internal resources, methods, SOPs, and overall approachOur strength : An exciting field of activity in a challenging clinical environmentAn autonomous area of responsibilityActive participation in an international clinical teamIntensive training with mentoring programDiverse benefits such as mobile working, bike leasing and company pensionApply now and join the Artivion team. We look forward to hearing from you!Direkt auf diese Stelle bewerben Daniel Weber, [email protected], T +49 (0)7471 922 353 JOTEC GmbH, a wholly owned subsidiary of Artivion, Inc. Lotzenäcker 23, 72379 Hechingen, www.artivion.com