About the Role
Role details below.
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 Mark.
- 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 clinical studies; stay informed about applicable clinical landscapes and trends.
- 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.
- Conduct proofreading, editing, document formatting, review comment integration and document completion / approval activities.
- Manage CEP/CER timelines required by product development teams and global Regulatory Bodies by utilizing appropriate project management tools.
- Serve as the SME and/or functional representative for R&D development activities (e.g., Product or Technology Development Process teams) and support broader Clinical/Medical Affairs activities such as Regulatory submissions/responses.
- Perform periodic reviews of risk documentation and product labeling; ensure appropriate updates are implemented.
- Provide clinical perspective and support and guide new product development for CE Mark purposes. May require participation in ongoing core team activities (e.g., weekly meetings) or provide periodic participation and input as needed.
- Support the clinical affairs (CA) team with the creation of clinical content for other documents including Investigator brochures, manuscripts, scientific abstracts, conference presentations, and posters based on Intuitive clinical trials.
- Support the CA team with the development and writing of clinical study protocols and Clinical Study Reports (CSRs).
- Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US and OUS guidelines)
Requirements
- Previous experience in the application of in-depth therapeutic and device knowledge for the development of clinical evaluation plans and reports
- 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.
- Expertise in clear and effective oral and written communication and in technical or scientific writing
- A minimum of 5 - 8 years
