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Clinical Evaluation Specialist

Company: DGN Technologies
Location: Sunnyvale
Posted on: March 27, 2020

Job Description:

Primary Function of Position This position reports to Manager, Clinical Affairs, (Clinical Evaluation) and requires a strong candidate with experience in medical writing of clinical regulatory documents. The position will mainly focus on development of Clinical Evaluation Reports (CERs), with potential for future additional responsibility for development of other clinical evidence documents. The purpose of this job is to author and develop clinical evaluation reports (CERs) per MEDDEV 2.7.1 Rev 4, to meet essential requirements in support of submission for CE Mark application to obtain Declaration of Conformity and EU market clearance, recertification and proposed indicationlabeling changes, as well as CER updates to maintain EU product conformance. Roles and Responsibilities This position has responsibility and authority for Authoring Clinical documentation mainly the Clinical Evaluation Reports CER including clinical section of regulatory authority requests. Acquire knowledge of therapeutic areas, competitor devices, current clinicalmarket developments, literature review processes and the ability to keep abreast of current literature. Participates in andor performs comprehensive literature searches to develop 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. Providing product guidance to the clinical librarian to help with conducting literature searches on productsproduct families. Review the literature and interpret and summarize risks, alternate therapies and device specific benefits from literature collect and summarize primary data to support risk assessment. Critically appraise scientific literature and write clinical summaries for products and surgical procedures Managing CER timelines required by product development teams and global Regulatory Bodies by utilizing the appropriate project management tools. Serve as a functional representative for RD development activities (e.g., Product or Technology Development Process teams) and will support broader ClinicalMedical Affairs activities such as Regulatory submissionsresponses.. Interacting with internal teams (engineeringproduct developmentregulatory) to define the plan and strategy for development of the Clinical evaluation reports for new products requiring CE Mark. Conduct proofreading, editing, document formatting, review comment integration and document completion approval activities. Perform periodic reviews of risk documentation and product labeling ensure appropriate updates are implemented. Provide clinical perspective and support to guide new product development for CE Mark purposes. May require ongoing core team support (e.g., weekly meetings) or periodic, as needed participation and input. May assist with creation of clinical content including the preparation of manuscripts, scientific abstracts, conference presentations and posters based on Intuitive clinical trials. May author Protocols andor routine Clinical Study Progress Reports. Ensure compliance with corporate (e.g., SOP s) and regulatory requirements (e.g., GCP and US and OUS guidelines) SkillJob Requirements Competency Requirements (Competency is based on education, training, skills and experience.)In order to adequately perform the responsibilities of this position the individual must Previous experience in the application of therapeutic and device knowledge to development of clinical evaluation reports. Must have a minimum of 2-4 years of medical writing experience Minimum of 0-2 years of experience in clinical evaluation report writing in a medical device industry is preferred. Ability to identify critical information needs and identify roles individuals to involve for decision making within clinical evaluation assessment and report development. Strong experience in conducting literature searches, reviews and appraisal of the scientific data. Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing demonstrated effective scientific writing skills. Excellent critical and analytical thinking skills. MD, PhD or M.S. degree in scientific field is desired. Must have high level of attention to detail and accuracy. Must be able to work effectively on cross-functional teams. Must be able to manage multiple projects across numerous surgical disciplines. Strong communication, presentation and interpersonal skills with high attention to detail and organization. Strong experience in protocol development, writing clinical section for regulatory submission and clinical evaluation report writing. Ability to learn quickly and self-educate on different surgical specialties as applicable to medical products and procedures (Self-starter attitude) Consistently shows dedication or strong work-ethic to help meet aggressive timelines or multiple projects when necessary. Thanks, Taj Singh 408-460-6080

Keywords: DGN Technologies, Sunnyvale , Clinical Evaluation Specialist, IT / Software / Systems , Sunnyvale, California

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