Director Global Regulatory Advertising & Promotion

Company Description

At Intuitive, we are united behind our mission: 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.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world 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 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 advance the world of minimally invasive care.

Job Description

Primary Function of Position

A highly visible leadership role driving regulatory advertising and promotion (A&P) activities in identifying and integrating regulatory and compliance requirements to facilitate materials review, product material communication and optimize the A&P process working closely with the marketing and clinical teams.

The Director of global regulatory advertising and promotion is the person responsible for the corporate A&P process to ensure compliance and management of content and claims per products documents or any tool used for communication. This is separate from being responsible for any business process tool supporting the A&P process (e.g., Veeva, MedReview, etc.).

This leader will be responsible for continuing to build the associated processes and to deliver insights and prepare the organization to meet current and future regulatory requirements applicable to Intuitive’s processes and product portfolio.

This position will lead cross-functional review and assessments for all BU and product portfolio management associated with product launch documents.
This individual will be able to understand the current complexities of the organization’s regulatory processes, critical information, and how those processes work in order to simplify them and work closely with the business partners.

Roles & Responsibilities

• Manage the full scope of the global A&P process and its supporting personnel, leading the A&P team related to all corporate document review related to marketing, product claims, and intended uses.
• Act as a primary source of expertise related to A&P materials within the organization, reviewing complex, high-level materials used for product communication or advertising.
• Create and improve the maturity and compliance of Standard Operating Procedures (SOPs), templates, and forms.
• Liaise between in-country clinical, marketing teams in the Direct and Indirect QARA groups, Subject Matter Experts and Regulatory Affairs to facilitate completion of regulatory review of A&P. Work closely with the local process owners and business partners to ensure global procedures are followed and appropriate evidence/record is established to support audit readiness.
• Work closely with other managers and leadership teams to better ascertain how A&P can improve ‘forward looking’ regulatory requirements monitoring and provide inputs to the appropriate processes.
• Develop relationships necessary to exchange data and information with other intelligence groups across Intuitive such as: GAVE, Market Intelligence, Competitive Intelligence, and others, as the need arises
• Ensure that periodic updates are prepared as required by leadership and management forums (i.e. Quality Review Board (QRB), Regulatory Surveillance Operating Committee (RSOC), Management Review, etc.). Compiles and reports process metrics and KPIs related to Veeva tool; provides periodic process timeliness reports to help keep assessment and Implementation activities on-target.
• Work closely with the global regulatory, clinical and compliance organizations to fully understand applicable standards / regulations and implement processes to ensure Intuitive achieves and maintains compliance.
• Drive intelligence and communication of emerging regulatory trends related to advertising and promotion and implications to internal stakeholders.

Qualifications

Skills, Experience, Education, & Training:

• Bachelor’s degree in quality, regulatory, engineering, Engineering, Computer Science, comparable degree, or equivalent work experience required
• Minimum of 12 years of overall business experience required
• Minimum of 10 years of experience managing, building. or leading teams required
• Minimum 5 years’ experience with regulations related to advertising and promotion
• Experience developing, managing, and improving business processes required.
• Experience leading and implementing large scale programs required
• Regulatory certification from RAPS is a plus
• Experience speaking to executives and leading business change preferred.
• Willingness to travel and support regional / local team
• Building roadmaps for the implementation of large-scale programs
• Data management & analytics, database creation, or information modeling
• Collaborating with cross-functional teams including engineering, PMO, regulatory, quality, clinical affairs and others
• Presenting to executives and driving business change
• Detail orientated with expertise reading and interpreting regulations, directives, and standards as they relate to advertising and promotion
• Knowledge of Regulatory Policy creation, health authority mandates, law and guidance
• Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices.
• Ability to be effective in complex projects with ambiguity and/or rapid change.
• Ability to handle multiple tasks and to prioritize and schedule work to meet business needs.
• Detail oriented with emphasis on accuracy and completeness.
• Strong written and oral communication skills. Proficiency in written and spoken English and the site’s local language(s). Any second language is a plus.
• Travel Requirement minimum 25%

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.

Intuitive is an Equal 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.

Mandatory Notices

U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.

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

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

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.

Base Salary Range Region 1:$208,500 - $312,700
Base Salary Range Region 2: $177,200 - $265,800
Shift: Day
Workplace Type: Purposeful Onsite - This job requires being onsite for leader-defined events and activities which could be monthly/annually. Onsite frequency may increase based on business need.