Head of Medical Writing m/f/d

Your strength:

• Degree in medicine or natural science
• Long-standing years of experience as a medical writer in the medical / biomedical industry with evidence of increasing responsibility and technical development
• Proficient at writing protocols, manuscripts and study reports
• Aptitude for compilation, analysis, and presentation of data
• Ability to communicate fluently and effectively, both in writing and verbally
• Knowledge of ICH and GCP guidelines and any other regulations relevant to medical writing
• Competency to effectively manage and motivate teams to achieve corporate, departmental and program goals on time
• Efficiency in managing and motivating direct reports to maximize writers' contributions and career development
• Familiarity with medical devices, MDD and MDR
• Accomplished use of MS Word, PowerPoint and Adobe Acrobat
• Proficiency in written and spoken English
• Practice in managing medical writers preferred

Your contribution:

• 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 Managements 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

Our strength:

• An exciting field of activity in a challenging clinical environment
• An autonomous area of responsibility
• Active participation in an international clinical team
• Intensive training with mentoring program
• Diverse benefits such as mobile working, bike leasing and company pension

Apply now and join the Artivion team. We look forward to hearing from you! 

Daniel Weber, jobs.europe@artivion.com, T: +49 (0)7471 922 353
JOTEC GmbH, a wholly owned subsidiary of Artivion, Inc.,
Lotzenäcker 23, 72379 Hechingen
www.artivion.com