Medical Writer I

2 days ago

Melbourne, Australia Avania Full time

Company profile: _
- The fast-growing Medical Writing team is hiring again _
- Avania has been a contract research organization for over 30 years, assisting in the design and conduct of clinical studies for medical devices. We organize patient studies in Europe, the United States, Australia and beyond, in numerous therapeutic areas._
- You will be part of a fast-growing Medical Writing team, with circa 10 Medical Writers. The majority of the team is located in Bilthoven (The Netherlands), but the team is expanding to other regions as well. You will work on a high level of quality, in close collaboration with other departments involved in clinical research (such as clinical operations, analytical services). There is substantial time for support of your personal career path._
- _
- Function profile:_
- As a Medical Writer, you are involved in:_
- _Clinical study design and study protocol writing_
- _Clinical data analysis and study report writing _
- _Clinical evaluation and reporting, related to the safety and performance of the medical device in the context of other medical alternatives_
- _Manuscript writing and editing _
- _Project management and client collaboration_
- Function requirements_:_
- _Post-graduate experience in (para)medical life science, or equivalent training and experience in medical writing, systematic review and clinical data appraisal, PhD degree in (para)medical life sciences preferred_
- _Excellent writing skills, with minimum of 3 years of experience in medical writing (position role may be adjusted based on experience)_
- Experience within the medical device industry and knowledge of clinical evaluation report regulatory requirements, evidence generation, and CER document creation is required
- Demonstrated knowledge and experience in quality regulatory compliance, complaint handling, adverse event reporting, medical device risk management processes, and experience with common bio statistical methods is preferred
- _Knowledge of the regulatory framework with respect to medical devices, including ICH-GCP, FDA regulations and ISO 14155_
- _Fluent in English, written and spoken _
- _32-40 hours a week available_
- Competencies:_ _
- _Strong project management skills, including organizational and time management skills_
- _Able to work independent with mínimal supervision_
- _Strong communication skills, e.g. able to explain technical concepts in a clear and understandable manner_
- _Strong analytical skills_
- _Client oriented_
- We offer: _
- _Participation in all aspect of clinical research in the field of medical devices_
- _An international setting that provides a broad field of experience and knowledge _
- _A fast-growing organization with opportunities for personal growth _
- _A dynamic team_
- _Trainings trajectory including personal development_

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