Senior Clinical Scientist

This is a fully remote position, open to applicants in California.

📋 Description

• This role reports to the Manager/Sr. Manager of Medical Sciences and seeks a qualified candidate with extensive expertise in analyzing medical literature, clinical trial data, and pre-clinical studies, along with a solid understanding of relevant regulations and standards.

• The primary focus of this position will be on the creation of Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs), with the potential for future responsibilities in the development of additional clinical evidence documents.

• The objective of this role is to collaborate in formulating strategies for developing CEPs, followed by creating clinical evaluation reports (CERs) in accordance with EU MDR, to fulfill essential requirements for CE Mark applications, thereby obtaining Declaration of Conformity and EU market clearance, re-certification, and proposed indication/labeling modifications.

• Additionally, the role includes the regular updating of CEPs and CERs to ensure ongoing EU product compliance.

• Engage with internal cross-functional teams (engineering, product development, regulatory affairs, post-market surveillance) to outline and strategize the development of CEPs and CERs for new products that require CE Marking.

• Create and author clinical documentation for regulatory submissions, focusing primarily on key sections of the CEP and the complete CER document.

• Prepare and author responses to inquiries and requests regarding clinical documentation from regulatory authorities.

• Hold or gain comprehensive knowledge of therapeutic areas, competitive devices, current clinical and market developments, literature review processes, and maintain awareness of the latest literature.

• Participate in and/or conduct thorough literature searches to develop and sustain a deep understanding of the current scientific literature necessary to support specified product lines and related clinical studies; remain informed about relevant clinical landscapes and trends.

• Offer product guidance and expertise to the clinical librarian to assist in performing literature searches on products and product families.

• Review scientific literature and analyze and summarize published data concerning risks, alternative therapies, and device-specific advantages; gather and summarize primary data to aid in risk assessment.

• Critically evaluate scientific literature and compose clinical summaries for products and surgical procedures.

• Conduct proofreading, editing, document formatting, review comment integration, and activities related to document completion and approval.

• Oversee CEP/CER timelines required by product development teams and global regulatory bodies by utilizing suitable project management tools.

• Act as the subject matter expert (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.

• Regularly review risk documentation and product labeling; ensure that necessary updates are executed.

• Provide clinical insights and support new product development aimed at CE Marking purposes.

• May necessitate participation in ongoing core team activities (e.g., weekly meetings) or provide periodic input and engagement as required.

• Assist the clinical affairs (CA) team in generating clinical content for various documents, including Investigator brochures, manuscripts, scientific abstracts, conference presentations, and posters based on Intuitive clinical trials.

• Support the CA team with the formulation and writing of clinical study protocols and Clinical Study Reports (CSRs).

• Ensure adherence to corporate (e.g., SOPs) and regulatory standards (e.g., GCP and US and OUS guidelines).

⛳️ Requirements

• Previous experience in applying in-depth therapeutic and device knowledge for the creation of clinical evaluation plans and reports.

• Ability to pinpoint critical information needs and identify the necessary roles/individuals to involve in the decision-making process during clinical evaluation assessments and report development.

• Strong background in conducting literature searches, as well as reviewing and appraising scientific data.

• Proficient in clear and effective oral and written communication, including technical or scientific writing.

• A minimum of 5 to 8 years of medical writing experience.

• Excellent critical thinking and analytical abilities.

• High attention to detail and accuracy.

• Ability to collaborate effectively with cross-functional teams.

• Capable of managing multiple projects across various surgical disciplines.

• Strong communication, presentation, and interpersonal skills, with a keen attention to detail and organization.

• Significant experience in protocol development, writing clinical sections for regulatory submissions, and creating clinical evaluation reports.

• Quick learner with the capacity to self-educate on diverse surgical specialties relevant to medical products and procedures (self-starter attitude).

• Consistent dedication and strong work ethic to meet demanding timelines while managing multiple projects, when necessary.

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

🏝️ Benefits

• Comprehensive health insurance plans.

• Opportunities for professional development and continued education.

• Flexible working hours and potential for remote work.

• Collaborative and supportive work environment.

• Competitive salary and performance-based incentives.