Senior Medical Writer
About The Position
The Senior Medical Writer is responsible for developing, writing, and managing high-quality clinical and regulatory documents that support compliance and product lifecycle needs for global standards such as EU MDR and FDA regulations. This includes planning, implementing, and reporting clinical data collection for Post-Market Clinical Follow-up (PMCF) and clinical trials, ensuring adherence to global regulatory standards. The role collaborates cross-functionally to maintain clinical documentation within the Quality Management System and stays current with scientific literature and regulatory requirements.
Requirements
- Experience in developing, writing, and managing clinical and regulatory documents.
- Knowledge of global standards such as EU MDR and FDA regulations.
- Experience in planning, implementing, and reporting clinical data collection for PMCF and clinical trials.
- Ability to ensure adherence to global regulatory standards.
- Cross-functional collaboration skills.
- Ability to maintain clinical documentation within a Quality Management System.
- Up-to-date knowledge of scientific literature and regulatory requirements.
Responsibilities
- Developing, writing, and managing high-quality clinical and regulatory documents.
- Supporting compliance and product lifecycle needs for global standards such as EU MDR and FDA regulations.
- Planning, implementing, and reporting clinical data collection for Post-Market Clinical Follow-up (PMCF) and clinical trials.
- Ensuring adherence to global regulatory standards.
- Collaborating cross-functionally to maintain clinical documentation within the Quality Management System.
- Staying current with scientific literature and regulatory requirements.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
