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Global pharmaceutical company that is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world is seeking an Executive Director, Consumer/Digital Compliance to join the team.
The company markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women’s health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, the company is preparing to launch and scale multiple stealth digital and consumer-focused startups, ready to transform the medical aesthetics and beauty space. With funding already in place, these startups are well positioned to disrupt the multi-billion dollar US medical aesthetics market, infusing cutting edge technology and content into an industry primed for innovation.
Our client is looking for a dynamic leader who will provide compliance business partner support to:
the design, launch and delivery teams by advising on program/initiative strategy and design;
prescription drug/device advertising, providing real-time review and approval of content and other deliverables; collaborating on marketing efforts;
answering compliance and risk-management related questions;
monitoring the administration and use of the digital platforms while advising on appropriate corrective action;
routinely reporting to Global Compliance and the project leadership team.
Working under limited direction, the Executive Director works with the initiative oversight Board and the various design, launch and delivery teams to understand business objectives and priorities, and provide compliance support on strategy, tactics and operations. This position is responsible for the evaluation of prescription drug/device digital programs/platforms, consumer programs, company and user generated content, and the use of social and related media while providing guidance to help achieve goals while mitigating risk to the company.
Primary Job Responsibilities: Responsibilities include providing compliance support related to various business activities, with a primary focus on (1) serving as the compliance advisor for the teams leading the strategy, design and implementation of the various digital and consumer platforms as well as (2) serving as the day-to-day compliance lead responsible for reviewing and approving (and escalating as necessary) Company and user generated content (to ensure compliance with the Federal Food, Drug & Cosmetic Act and related laws/regulations), platform and media design, customer (HCP and consumer) interactions and communications, pricing and contracting implications, privacy and HIPAA questions, adverse event considerations, among other compliance-related topics. This role will also be responsible for developing and managing an on-going compliance monitoring program and for creating dashboards and metrics for executive updates. Responsibilities will also include functioning as the primary point of contact and collaboration with the Legal, Regulatory, and Medical subject matter experts. Ultimately, this role is responsible for assisting Compliance leadership with supporting these strategic digital and consumer initiatives to encourage the fast and effective implementation of these initiatives while ensuring compliance with Company guidelines and policies and federal and state requirements.
Collaboration – Partner with multiple cross-functional stakeholders, including internal (Legal, Regulatory, Medical, Commercial) and external (consultants, content developers, editors, subject matter experts, technical designers, social media drivers, etc.) business partners in the design and implementation of strategic digital and consumer prescription drug/device initiatives
Advistory – Advise cross-functional business partners on compliance guidelines, policies and better practices related to the medical aesthetics business
Agility – Ability to work and respond independently in a highly fast paced and innovative environment; comfortable evaluating risk and balancing risk tolerance with business objectives in the digital and consumer space
Problem Solving – Provide creative solutions to mitigate risk while supporting business goals and objectives
Business Knowledge – Develop a comprehensive understanding of the goals of the business and the objectives of the various initiatives
Assurance & Reporting – Provide strategic insights to the business partners and internal/external stakeholders based on real-time monitoring and compliance data analysis
Essential Job Functions:
Advise on the strategy, design and implementation of the various digital and consumer platforms
Provide day-to-day compliance support for reviewing and approval (and escalating as necessary);
company and user generated content (on-label, comparative/superiority claims, etc.)
platform and media design
customer (HCP and consumer) interactions and communications
pricing and contracting implications
privacy and HIPAA questions
adverse event considerations
other compliance-related topics
Provide timely and practice advice and support for questions and concerns regarding compliant activities
Serve as the primary point of contact and collaboration with the Legal support team, identifying those matters that will require specific legal review and/or approval, as well as the Regulatory and Medical subject matter experts
Routinely monitor activities for compliance with company guidelines and policies
Provide data analytics and reporting related to monitoring findings and other compliance observations to internal and external stakeholders
Manage and maintain database of compliance activities, observations, resolutions, etc.
Assist in compliance audits, monitoring and investigations as needed
Experience working in and/or supporting prescription drug/device and consumer businesses and digital ventures
Interest in being an important part of building early stage consumer focused ventures
Significant commercial compliance experience and subject matter expertise, including the risks (i.e., appropriate prescription drug/device promotion, HCP engagement, comparative/superiority claims, privacy and HIPAA, government price reporting, adverse event reporting, etc.)
Strong familiarity with the healthcare and related laws and regulations that impact the design and management of consumer programs and digital platforms (federal fraud and abuse laws and guidance, including the ACCME guidelines, the Office of Inspector General guidance, and the federal Food, Drug and Cosmetic Act and an understanding of the roles and authority of government agencies and industry partners including FDA, OIG, FTC, PhRMA and AdvaMed).
Bachelor’s degree required; advanced business or law degree a plus
at least 10+ years of experience in Compliance or related Legal/Regulatory role; highly demonstrable experience supporting a consumer and/or digital business a must; 5+ years of experience in the pharmaceutical or medical device industry a strong plus
Prior experience in business/customer facing role required
Prior experience managing projects
Knowledge, Skills and Abilities:
Quick and agile solution provider
Comfort balancing risk management needs and critical business objectives
Adept at influencing without authority
Strong collaborator who is equally comfortable challenging the status quo
Able to balance the need to triage problems while still driving to sustainable solutions
Shows initiative in the face of ambiguity
Requires strong leadership and influencing skills to manage complex proejct
Responsible to implement and maintain activities across multiple initiatives simultaneously
Serves as advisor to client and project manages complex, revenue generating business
Internal Number: DIGCOMPL 1079
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