1MED SA, Contract Research Organization that provides clinical and regulatory services to medical device, in vitro diagnostic, pharmaceutical companies is hiring.
Are you a dynamic person, interested in an innovative and smart approach to clinical research with focus on the medical device field? What an exciting time to come on board: together with our clinical team you will be supporting MedTech companies in seeking and maintaining compliance to the new Medical Device Regulation 2017/745 requirements, generating strong and supportive clinical data with reference to medical device’s specific claims.
We are looking for a Medical Writer (MW) with at least 2-3 years of experience in the field, able to work independently with project team members and the Biostatistics and Data Management staff to draft, edit, and finalize a variety of documents including study protocols, manuscripts for peer-reviewed publications and clinical study reports to join your our team!
Role with high career development opportunities.
To join us in this exciting new venture, please contact us!
– Designs scientifically sound studies in conjunction with project teams in Clinical Operation, Start Up, Biostatistics and Data Management.
– Drafts clinical study protocols and study reports. Provides editorial assistance in support of scientific publications and/or post-marketing study activities.
– Interfaces with Strat Up and other groups within company to ensure the accuracy and timely review and revision of all cross-functional documents supporting regulatory submissions.
– Develops scientific expertise in the application of new medical devices, drugs or food supplements to personalized healthcare.
– Ensures high quality documentation with regard to scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines.
– Ph.D Degree Strongly Preferred
– Previous experience as Medical Writer in CRO preferred.
– Expert knowledge and application of scientific principles and concepts.
– Excellent and proven team skills, written and oral communication skills.
– Strong ability to handle multiple projects simultaneously.
– Demonstrated success in technical proficiency, scientific creativity, collaboration with others and independent thought.
– Advanced technical writing skills.
– Ability to produce reports and documents independently and evaluate the writing of others.
– Demonstrated creativity and ingenuity through the development of Client, multi-disciplinary approaches to projects and strategic issues.
– Skill and ability in implementing strategic projects, acting as a catalyst to remove organizational barriers, reduce cycle times and direct process improvements.
Apply to our open position and join us in this exciting new venture, becoming part of the 1MED team!