Senior Medical Writer and Regulatory Specialist
vor 1 Woche
We are seeking a highly skilled and experienced Senior Medical Writer and Regulatory Specialist to join our team at JOTEC GmbH. As a key member of our regulatory affairs department, you will be responsible for leading the development of high-quality medical and regulatory documents, ensuring compliance with regulatory requirements, and providing strategic guidance to our clinical partnerships.
Key Responsibilities- Develop and implement medical and regulatory writing best practices to ensure consistency and quality of documents
- Lead a team of medical writers to generate key documents in internal clinical partnerships with relevant functions (Project Management, Data Management, and CRAs) on schedule
- Strategically and timely complete 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
- 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
- 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
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