Senior Medical Writer (m/f/d) - Hechingen, Germany or Remote within EMEA
Your Strength
- At least 4 years of experience in medical writing or a related field
- Advanced degree in a scientific or technical discipline (PhD or MD preferred)
- Solid clinical knowledge, ideally with background in Cardiology
- Proven experience in authoring clinical research documents and regulatory submissions
- Strong ability to independently evaluate and interpret medical literature and data
- In-depth knowledge of medical writing standards, clinical evaluation (e.g. CERs, PMCF), and MDR requirements
- Excellent English communication skills; scientific writing fluency is essential
- Skilled in cross-functional collaboration with departments such as Clinical Affairs, R&D, RA/QA, and Marketing
- Experience mentoring or reviewing work of junior medical writers is a plus
Your Contribution
- Act as lead writer on complex projects (global/multi-project/new product development)
- Write, review, and submit scientific manuscripts, abstracts, presentations, and regulatory documentation
- Author Clinical Evaluation Reports (CERs), PMCF Plans, Clinical Evaluation Plans, and related documents
- Independently conduct gap analysis and evidence assessments
- Evaluate technical file documents (e.g. risk management, IFU) against clinical and literature data
- Collaborate with internal stakeholders (Clinical, R&D, RA, QA, Marketing) and external partners (CROs, surgeons)
- Support response to regulatory authority questions and submissions
- Conduct state-of-the-art evaluations and risk/benefit assessments across the product lifecycle
- Develop and implement literature search strategies and critically assess scientific validity and relevance
- Take ownership of assignments with minimal supervision and contribute as a subject matter expert
Our Strength
- A mission-driven Clinical Affairs team with a focus on innovation and quality
- High-impact role with direct contribution to product safety and compliance
- Structured onboarding and continuous learning opportunities
- Hybrid or remote work flexibility within EMEA
- Attractive benefits including pension plan and EGYM Wellpass
Contact
JOTEC GmbH, a wholly owned subsidiary of Artivion, Inc.,
Lotzenäcker 23, 72379 Hechingen
www.artivion.com
