Medical Writer

La Rochelle (17) - France

Step out of your comfort zone, excel and redefine the limits of what is possible. That’s just what our employees are doing every single day – in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people.

We are looking for people who are keen to try something new. In a context of innovation, growth and evolution of the European regulation on medical devices (MDR), the Clinical Affairs Department is a key function of the division and recruits to strengthen its team

Your main tasks will focus on creation and maintenance of clinical evaluation related documentation during product lifecycle and are based on the following responsibilities
• Identify critical information needs and identify roles / individuals to involve for building strategy, planning and action plan for clinical evaluation process in line with product roadmap and business strategy.
• Perform relevant systematic literature analysis based on strong experience in conducting literature searches, reviews and appraisal of the scientific data to support ongoing activities and future projects. Write corresponding literature review plans and reports.
• Provide clinical perspective and support to guide new product development for CE Mark or for other country application purposes.
• Liaise with product and technical leads, and PMS/vigilance leads, to gather information and data required to complete/update Clinical Evaluation documentation
• Create and/or maintain Clinical Evaluation plan and report, collaborate to PMS plan and report with regards to clinical aspects.
• Perform reviews of risk documentation and product labelling; ensure appropriate updates are implemented
• Acquire knowledge on therapeutic areas, competitor devices, current clinical/market developments
• Ensure compliance with corporate (e.g., SOPs) and regulatory requirements and guidances (e.g., MDR, MEDDEV 2.7.1.)
• Create clinical content including the preparation of manuscripts for peer-review journals, scientific abstracts and posters.

Skills :

• Language: fluent English mandatory
• Familiar with Office Pack, email and Internet and bibliographic search engines
• Familiar with scientific literature (interpret, write, review). Strong knowledge of writing clinical evaluation reports, and scientific, medical/clinical, and technical content
• Knowledge of regulatory requirements for medical devices (MDD, MDR), ISO standards, Meddev 2.7.1 guideline, ICH.
• Ability to quickly acquire knowledge and understanding of medical terminology, clinical practices, medical device environment
• Knowledge of FDA regulation would be appreciated
• Level PhD or Master scientist,
• Medical writing experience of more than 5 years in medical and scientific writing.
In a spacious modern setting full of opportunities for further development, ZEISS employees work in a place where expert knowledge and team spirit reign supreme. All of this is supported by a special ownership structure and the long-term goal of the Carl Zeiss Foundation: to bring science and society into the future together.

Join us today. Inspire people tomorrow.

Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity.

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