Director Global Regulatory Advertising & Promotion

Intuitive•Sunnyvale, CA

About The Position

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.

Requirements

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
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).

Nice To Haves

Regulatory certification from RAPS is a plus
Experience speaking to executives and leading business change preferred.
Willingness to travel and support regional / local team
Any second language is a plus.

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.