- Critically review clinical content in promotional material and provide consultancy to cross-functional stakeholders to ensure a balance of messages and relevance of the content in accordance with applicable medical device regulations and available clinical evidence.
- Ensure content is adequately substantiated by scientific data (verifying the content is accurately cited and properly referenced); check authenticity and validity of references; determine that references in promotional materials specifically support clinical claims made in the material; and ensure the context of the reference is appropriately reflected in the promotional claims in the material.
- Provides clinical affairs guidance in partnership with regulatory affairs and marketing during the development of marketing materials as needed.
- Pursues and comprehends diverse viewpoints from internal and external key stakeholders to provide risk assessment and mitigation strategies as well as effective negotiation leading to resolution for approval of marketing materials.
- Support and/or provide training or develop internal guidance documents related to best practices for clinical claim development and substantiation.
- May assist with development of clinical literature reports or other clinical documents such as protocols, clinical study reports, and peer-reviewed publications.
- Ensure compliance with corporate (e.g., SOP's) and regulatory requirements (e.g., GCP and US and OUS guidelines)
Clinical Affairs Specialist 3 - Sunnyvale, United States - Intuitive Surgical
Description
Job Description
Primary Function of Position
This position reports to the Manager, Clinical Affairs, Advertising & Promotion (A&P) Review and is mainly responsible for reviewing A&P material for conformance to known clinical evidence landscape and applicable A&P guidelines and regulations, with potential for future additional clinical responsibilities including literature review and medical writing such as study protocols, clinical study reports, and peer-reviewed publications. This position will also provide clinical guidance during the review and the development of marketing material based on clinical evidence. The candidate will be required to be capable of interpreting results from published literature and be able to correlate a clinically meaningful understanding to marketing materials in accordance with the desired messaging.
As a key cross-functional constituent, this employee will work closely with functions across the organization – Marketing, Regulatory Affairs, Clinical Development Engineering (CDE), Global Access Value Economics (GAVE), and commercial functions to ensure scientific accuracy and meet business objectives.
This position requires being on-site at the Sunnyvale, CA locations 3-4 times per year.
Essential Job Duties