Associate Medical Writer 50%
Vor 3 Tagen
**ABOUT STRAUMANN**
Headquartered in Basel, Straumann is a global leader in implant and restorative dentistry and oral tissue regeneration. Having pioneered many of the most influential technologies and tech-niques in our field, we have a tradition of doing more to advance dental regeneration, restora-tion and replacement, as well as patient care.
Straumann partners with passionate people who fit in with the agile dynamics of our size-for-success company. People at Straumann appreciate the opportunity to shape our future and create impact.
Encouraging leadership and inspiring ideas from our people has guided us through our proud history of pioneering innovations.
**JOB PURPOSE**
As a medical writer, you will play a crucial role in our Post-Market Follow-Up (PMCF) Team, crafting PMCF Plans and Reports, and contributing to the Clinical Evaluation and Post-Market Surveillance documentation. In this role you will collaborate with internal and external partners to evaluate clinical data from diverse sources. By leveraging your medical writing skills and experience, you will directly contribute to fulfilling our post-market clinical data obligations under the Medical Device Regulation, leading to a successful maintenance of our comprehensive dental medical device portfolio on the European market.
This is an exciting opportunity to work in a team-based environment where your contributions will directly impact on our success. If you have a passion for medical writing, a quality mindset, and a drive to excel, we want to hear from you
**_
This position will have a workload of 50%_**.
**Main Tasks and Responsibilities**
- Evaluating clinical data from sources such as clinical investigations, device registry, literature, or congress reports
- Establishing and updating PMCF Plans and PMCF Reports for medical devices within our portfolio
- Summarizing output of PMCF activities in Clinical Evaluation Reports and Periodic Safety Update Reports
- Collaborating with other stakeholders to ensure timely delivery of key documents
- Ensure consistency and integrity of data across all deliverables
- Working in compliance with applicable regulations and guidelines
**Your experience / personal profile**:
- Education in dentistry, biological science, or a similar field
- Prior medical writing experience in a regulated industry/environment
- Excellent medical writing skills
- Understanding of Post-Market Surveillance and Clinical Evaluation requirements under the EU MDR; knowledge of the applicable guidance documents
- Fluency in English
- Structured and pragmatic working style
- Self-motivation and accountability
- Excellent interpersonal skills, ability to work collaboratively in a matrix organization
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