13 days old

Clinical Affairs Specialist III- Advertising and Promotional (A& P) Material Review

Intuitive Surgical, Inc.
Sunnyvale, CA 94086
  • Job Code
    INSUUS214056EXTERNALENUS
At Intuitive, we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. Our mission is our guiding force; our culture is the DNA that makes us unique.

As a pioneer in robotic-assisted surgery (RAS), we have been expanding our innovations through technology to help make a difference in the world. For 25 years, human ingenuity has guided our journey to help solve some of healthcare's complex challenges.

We believe a great idea can come from anywhere-inclusion and mutual respect are vital to our culture. We value character grounded in integrity, a strong capacity to learn, the energy to get things done, and diverse experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and strive to achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients.

Together, let's help to advance the world of minimally invasive care.

Primary Function of Position:

As a Clinical Affairs Specialist, this role is responsible for reviewing 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. Foresee challenges and develops critical concepts and methodologies to overcome those.

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), Global Public Affairs (GPA), Regulatory Compliance, Training, Legal, and commercial functions to optimize the strategies for advertising and promotional materials/collaterals to meet business objectives.

Roles and Responsibilities:

This position has responsibility and authority for:

  • Provides clinical affairs guidance in partnership with regulatory affairs, legal and marketing during the development of advertising and promotional materials including development of claims matrices for surgical procedures and product claims.
  • Critically review and provide solutions to complex promotional strategies to ensure balance of the messages, and relevance of the content of the materials/activities in accordance with applicable medical device regulations and available clinical evidence.
  • Ensure content is well substantiated by scientific data (verifying the content is accurately cited/properly referenced); check authenticity and validity of references; determine that references in promotional materials specifically support product claims made in the material; and ensure the context of the reference is appropriately reflected in the promotional claim(s) in the material.
  • 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 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, US and OUS guidelines)

Skill/Job Requirements:

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 (Ph. D or M.D.) or Master's degree in a scientific/bioengineering field with at least 4-5 years of experience of reviewing of advertising, promotional and marketing /commercial collaterals
  • 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)
  • Results-driven attitude and strong problem solving skills, 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

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Shift : Shift 1 - Day

Travel : Yes, 10 % of the Time





Posted: 2021-09-11 Expires: 2021-10-10
Sponsored by:
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Sponsored by:
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Clinical Affairs Specialist III- Advertising and Promotional (A& P) Material Review

Intuitive Surgical, Inc.
Sunnyvale, CA 94086

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