Primary Function of Position

This position reports to Manger/Sr. Manager, Medical Sciences and requires a strong candidate with expertise in the analysis of medical literature, data from clinical trials and pre-clinical studies, and sound knowledge of applicable regulations and standards. The position will mainly focus on the development of Clinical Evaluation Plans (CEPs) & Clinical Evaluation Reports (CERs), with a potential for future additional responsibility in the development of other clinical evidence documents. The purpose of this job is to work collaboratively to develop strategies for the creation of CEPs followed by the development of clinical evaluation reports (CERs) per EU MDR, to meet essential requirements in support of submission for CE Mark application to obtain Declaration of Conformity and EU market clearance, re-certification and proposed indication/labeling changes. Further, the responsibility includes the development of regular CEP and CER updates to maintain EU product conformance.

Essential Job Duties

• 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)

Qualifications

Required Skills and Experience

• 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 of medical writing experience
• Excellent critical thinking and analytical skills
• A high level of attention to detail and accuracy
• Ability to work effectively with cross-functional teams
• Ability 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 sections of documents 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)
• Consistent dedication and strong work-ethics to meet aggressive timelines and simultaneous management of multiple projects, when necessary

Required Education and Training

• MD, PhD or M.S. degree in a scientific field

Preferred Skills and Experience

• Minimum of 2-4 years of experience in clinical evaluation report writing in medical device industry is preferred.

Additional Information

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate's experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate's qualifications, consistent with applicable law.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.