Jobbeschreibung
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 hiring
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
- 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