Reference #: JR5716 SUMMARY/JOB PURPOSE:

Responsible for primary regulatory review of promotional materials and scientific exchange communications. Provides regulatory strategic and operational leadership in the areas of advertising and promotion. This role demonstrates proficiency in understanding and interpreting clinical trial data to support Regulatory and cross-functional activities for Exelixis compounds. This role recognizes the different requirements and restrictions for external data communication and presentation and represents the Regulatory considerations and point of view. This role demonstrates cross-functional leadership, recognizing opportunities for multi-disciplinary collaboration and challenges regarding communication strategies and initiatives that cross multiple channels. Has regulatory responsibilities in Promotional Review Committees and/or Scientific Exchange Materials Review committees.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Ensures compliance with all FDA regulations for prescription drug, advertising, and promotions, provides strategic regulatory leadership throughout the development and implementation of all promotional initiatives and activities. Provides regulatory guidance on the review and approval of promotional materials and other related activities with a high level of independence.

Provides regulatory oversight and management of the processes and procedures governing RAMP.

Provides timely and solutions-oriented reviews of assigned advertising and promotion materials with a high level of independence.

Responsible for the regulatory review and approval of advertising and promotional materials and scientific exchange communications.

Serves as decision-making member of the Review of Advertising, Marketing, and Promotions (RAMP) committee and/or Medical Review committee (MRC).

Provides strategic and forward-looking guidance regarding processes and systems surrounding review committees. Leads the execution of process improvements.

Provides leadership within the Regulatory department, identifying and managing through completion departmental and cross-project initiatives and regulatory obligations.

Provides regulatory guidance for the development, review, implementation, and maintenance of promotional materials and other related activities with a high level of independence.

Serves as RAMP Chair overseeing the review and approval of RAMP and/or MRC materials. When necessary, leads, coordinates, and provides documentation of the escalation process with next-level up RAMP managemen

Responsibility and oversight of promotional material submissions under Form FDA 2253. Signatory for all OPDP submissions.

Manages the development of relevant correspondence with health authorities and interpretation of health authority comments, as well as serving as the primary liaison with relevant personnel in FDA's Office of Prescription Drug Promotion.

Maintains current awareness of evolving health authority interpretations, including advisory letters, enforcement letters and policy issues. Communicates significant changes or other relevant matters to internal partners and stakeholders.

Reviews and evaluates industry environment; performs competitive intelligence on promotional materials and activities.

Manages, maintains, and continuously improves processes and systems (including a web-based platform) for review and approval of promotional materials. Oversees and manages training on processes and systems.

Leads the creation, modifications, and maintenance of SOPs and work instructions for review, approval, and maintenance of promotional materials.

Mentors and provides oversight to junior department members supporting Commercial Regulatory Affairs activities.

Oversight for the regulatory review and approval of scientific exchange materials, including Medical Information requests, materials for the Medical Affairs field staff, and clinical trial support materials (e.g., external patient recruitment materials).

Oversight of clinical development communications and materials in support of Exelixis clinical trials, including site training slides and newsletters.

Liaises cross-functionally with partners in Commercial, Medical Affairs, Regulatory, Legal, Public Relations, and others to develop holistic strategies around communication initiatives, working within the regulatory framework and boundaries.

SUPERVISORY RESPONSIBILITIES:

Directly supervise employees.

Indirectly supervise employee(s) through a dotted line structure or via other subordinate supervisors.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience:

Bachelor's degree in related discipline and a minimum of fifteen years of related experience; or,

Master's degree in related discipline and a minimum of thirteen years of related experience; or,

PhD degree in related discipline and a minimum of twelve years of related experience; or,

Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

Minimum sixteen years pharmaceutical industry and/or regulatory agency experience or the equivalent combination of experience and education/training

Minimum nine years regulatory experience in a position of substantial responsibility.

Prior experience working with OPDP and/or review divisions at FDA required.

Experience in oncology preferred.

Knowledge/Skills:

Demonstrated knowledge of US and international regulatory requirements pertinent to this role.

Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.

Develops technical and/or business solutions to complex problems.

Exercises problem solving, strategic thinking skills with ability to impact and influence

Guides the successful completion of major programs, projects and/or functions.

Interprets, executes, and recommends modifications to departmental and cross-functional processes and standards.

Leads or manage the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods, and staffing.

Trains staff.

Performs a variety of complicated tasks with a wide degree of creativity and latitude.

Responsible for maintaining a working knowledge of regulatory requirements and guidelines and for communicating changes in regulatory information to departmental and team colleagues

Has good general knowledge of other related disciplines.

Applies strong analytical and business communication skills.

Collaborates and communicates effectively through all levels of management across multiple departments and functions.

Consistently meets deadlines without compromise to work with a high level of independence

Effective cross-functional collaborator and communicator with demonstrated ability to inspire others around a common goal

Uses broad expertise and knowledge to contribute to development of company objectives and principles and to achieve goals in creative and effective ways

Develops technical and/or business solutions to complex problems.

JOB COMPLEXITY:

Capable of proactively assessing workload, trends, tasks, and priorities for cross-functional activity.

Plans and executes multiple projects or activities, considering alternative methods and contingency plans to avoid potential issues.

Designs and implements s