Director Global Regulatory Advertising & Promotion

Director Global Regulatory Advertising & Promotion

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 :