Intuitive Surgical Careers
Clinical Evaluation Specialist
Primary Location: United States-California-Santa Clara County-Sunnyvale
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Primary Function of Position:
This position reports to the Sr. Director,
Clinical Affairs 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 indication/labeling 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 or possess in-depth knowledge of therapeutic areas, competitor devices, current clinical/market developments, literature review processes and the ability to keep abreast of current literature.
- Participates in and/or performs 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.
- Providing product guidance and expertise to the clinical librarian to help with conducting literature searches on products/product 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 SME and/or functional representative for R&D development activities (e.g., Product or Technology Development Process teams) and will support broader Clinical/Medical Affairs activities such as Regulatory submissions/responses..
- Interacting with internal teams (engineering/product development/regulatory) 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 and/or routine Clinical Study Progress Reports.
- Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US and OUS guidelines)
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 in-depth therapeutic and device knowledge to development of clinical evaluation reports.
- Must have a minimum of 5-8 years of medical writing experience for regulatory submissions.
- Experience with developing CERs per MEDDEV 2.7.1 Rev 4.
- Minimum of 2-4 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 desirable.
- 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