Head of Medical Writing (m/f/d)
Hechingen
Aktualität: 06.09.2024
06.09.2024, JOTEC GmbH
Hechingen
Head of Medical Writing (m/f/d)
Aufgaben:
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
Qualifikationen:
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