Head of Medical Writing
vor 4 Wochen
We are seeking a highly skilled Medical Writing professional to lead our team in creating high-quality documents that support our clinical partnerships and regulatory submissions.
About the RoleAs a Medical Writing expert, you will be responsible for establishing best practices for medical and regulatory writing, leading a team of writers to generate key documents, and supporting the development of clinical study protocols, clinical study reports, and regulatory submissions.
Key Responsibilities- Develop and implement medical and regulatory writing best practices to ensure consistency and quality of documents
- Lead a team of writers to generate key documents in internal clinical partnerships and support key documents in Artivion partnerships
- Strategically complete key documents such as clinical study protocols, clinical study reports, and regulatory submissions
- Coordinate document writing, review, and revision to ensure the highest quality in conformity with program strategy and objectives
- 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
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, and diverse benefits such as mobile working, bike leasing, and company pension.
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