Zeiss - Senior Medical Writer - La Rochelle
With nearly 25,000 employees, ZEISS is one of the world leaders in the optics industry. For more than 165 years, ZEISS has been contributing to technological progress with solutions dedicated to the semiconductor, automotive and machine tool industries, biomedical research, medical technology and spectacle lenses, photographic and cinematographic lenses, binoculars and planetariums. The CARL ZEISS Meditec division designs, manufactures and distributes a wide range of intraocular lenses, products, materials and instruments for ophthalmology.
In a context of innovation, growth and implementation of the European regulation on medical devices (MDR), the Clinical Affairs Department, key function of the division, recruits to strengthen its team a
Senior Medical Writer
Your main tasks will be both business operational and 'project management', and will focus on:
- the writing of regulatory and scientific documents which content concerns the clinical aspect of medical devices. You will guarantee accuracy, quality, methodology, regulatory compliance and editorial style.
- the participation, and / or management, of transversal projects for which the evaluation of clinical impacts is necessary.
On daily business, you ensure:
- planning and generation of reports integrating data from clinical studies and existing scientific literature for pre-market or post-marketing medical devices.
- research, selection, analysis of clinical data in accordance with the regulatory requirements or editorial guidelines in force
- good understanding of the levels of proof required to meet regulatory or marketing objectives.
- the scientific watch of your perimeter
The editorial aspect concerning the regulatory documentation will include the, clinical evaluation plans and reports, and related elements, required by the regulations in force (MDD, MDR). The scientific literature/documentation will include scientific articles for trade journals or peer review publications, bibliographic summaries and conference presentations as well as other written material on request from the business sector, marketing and research and development.
Regarding the 'project management' aspect, you will participate in or lead cross-department projects by ensuring that planning and tracking of agreed tasks are respected. In the context of international project teams, your relationship skills will allow you to communicate efficiently and share your expertise with participants from R & D, marketing, production, external partners (doctors, subcontractors etc ... ).
medical writer / pharmaceutical / medical device / scientific articles / clinical evaluations
- Knowledge of theories, principles and concepts typically acquired through more than 5 years of relevant writing experience in a clinical regulatory environment
- Excellent interpersonal, organizational and communication skills
- Excellent oral and written communication skills in presenting medical research data in fluent English
- Strong skills in interpreting clinical and statistical data
- Knowledge of regulatory requirements for clinical evaluation process (eg. EU Council Directive 93/42/EEC on Medical Devices and related guidances, ISO standards on Medical Devices, Meddev 2.7.1 guideline, ICH, FDA would be an advantage)
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