Clinical Scientist

Job description

Job responsibilities

• Interact with internal cross-functional teams (engineering, product development, regulatory, post-market surveillance) to define and plan the strategy for the development of CEPs and CERs for new products requiring CE…
• Develop and author clinical documentation for regulatory submissions, mainly key sections of the CEP and the entire CER document.
• Develop and author responses to the requests and questions on the clinical documentation from the regulatory authority.
• Possess or acquire in-depth knowledge of therapeutic areas, competitor devices, current clinical/market developments, literature review processes and the ability to keep abreast of current literature.
• Participate in and/or perform comprehensive literature searches to develop and maintain in- depth knowledge and understanding of current scientific literature required to support identified product lines and related…
• Provide product guidance and expertise to the clinical librarian to facilitate conducting literature searches on products/product families.
• Review scientific literature and interpret and summarize published data on risks, alternate therapies and device-specific benefits; collect and summarize primary data to support risk assessment.
• Critically appraise scientific literature and write clinical summaries for products and surgical procedures.

Job requirements

• Previous experience in the application of in-depth therapeutic and device knowledge to the development of Clinical Evaluation Plans and Reports.
• Minimum of 2 years of medical writing experience.
• Ability to identify critical information needs and identify roles/individuals to involve in the decision- making process within clinical evaluation assessment and report development.
• Strong experience in conducting literature searches, and review and appraisal of scientific data.
• Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing; demonstrated effective scientific writing skills.
• Excellent critical thinking and analytical skills.
• A high level of attention to detail and accuracy.
• Ability to work effectively with cross-functional teams.