Intuitive Surgical Careers
Senior Clinical Affairs Specialist - AP Material Review
Primary Location: United States-California-US-CA-Sunnyvale
Requisition ID: 182099
Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
Primary Function of Position:
The purpose of this job function of a Sr. Clinical Affairs Specialist is to primarily support review of advertising and promotional materials for conformance to known applicable medical device regulations within the United States, product specifications/applications and surgical procedure guidelines. This position will also provide guidance during the development of strategies for advertising and promotional materials/collaterals and claims development. The candidate will be required to have a broad understanding of surgical procedures, good knowledge of human anatomy, capable of interpreting results from published literature and is able to correlate a clinically meaningful understanding to marketing materials in accordance with desired messaging.
Roles and Responsibilities:
This position has responsibility and authority for:
• Provides clinical affairs guidance in partnership with regulatory affairs, legal , marketing and clinical development engineering during the development of advertising and promotional materials including development of claims matrices for surgical procedures and product claims• Reviews and approves proposed advertising and promotional materials for conformance to known applicable medical device regulations and available clinical evidence ensuring appropriate support for materials• Support and/or provide trainings or develop internal guidance documents related to best practices for advertising and promotional material development and reviews• Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and CFR 812)
Competency Requirements: (Competency is based on: education, training, skills and experience) In order to adequately perform the responsibilities of this position the individual must:
• Advanced degree in a scientific/bioengineering field ( MS, Ph. D or M.D.) with at least 2-4 years of experience of reviewing of advertising, promotional and marketing /commercial collaterals is required• Have the ability to understand and develop subject matter expertise of outcomes data from clinical studies in variety of clinical specialties (such as urology, gynecology, general and thoracic surgery) is preferred.• A good understanding of human anatomy and physiology is essential• Significant knowledge of clinical studies and study design, outcomes research and critical review of literature is necessary• Excellent ability to interact with internal and external stakeholders. Must be able to work effectively and collaboratively on cross-functional teams including marketing, legal, engineering, regulatory affairs, etc.• Possess knowledge of Good Clinical Practice and 21 CFR Part 812• Good understanding of US FDA advertising /promotional regulations• Basic understanding of statistics and statistical methods commonly used in peer reviewed articles• Must be able to manage multiple projects with competing priorities across numerous surgical disciplines• Strong communication, presentation and interpersonal skills with high level of attention to detail, accuracy and organization• Ability to learn quickly and self-educate on different surgical specialties (Self-starter attitude)• Consistently shows dedication or strong work-ethic to help meet aggressive timelines or multiple projects when necessary• Preference given to candidates with existing experience or familiarity with surgery/surgical technology
We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.