Title: Director, Compliance Business Partner – MS Business
Location: Edison, NJ or Remote
If you are interested in the below position, please send your resume to [email protected] and REFERENCE THE POSITION TITLE within the subject line.
The Director, Compliance Business Partner supports TG’s Multiple Sclerosis Business by providing proactive Compliance support and guidance. Given the growing and evolving nature of TGTX, and the Compliance Program along with it, this role will support the launch preparations the MS Franchise and the continuous improvement of the Compliance Program and Compliance Function. The role will also support implementation of the OIG’s Seven Elements of an effective Compliance Program for the MS business, including conducting live and transactional monitoring, training, creating/improving standards and supporting investigations when needed.
This role reports to the Chief Compliance, Ethics and Risk Management Officer.
––Actively engage with business partners to understand their needs and provide proactive compliance guidance on the development and execution of strategic and tactical initiatives.
––Provide leadership and guidance on business programs, identify compliance concerns, analyze alternatives and work with business partners to develop and implement solutions
––Work collaboratively across the business to develop, update, and implement compliance policies and procedures that are right-sized for TG and reflective of existing and updates to applicable laws, regulations guidance, codes, and policies
––Develop and deliver engaging communications and trainings
––Prepare and execute monitoring plans and other oversight programs for key areas of risk
––Foster a strong internal compliance, ethics, and speak-up culture by creating an environment in which employees see Compliance as a value-add strategic partner
––Assist with conducting investigations into allegations of violations of applicable laws, regulations or policies and recommend corrective action where appropriate
––Participate in internal risk management assessment activities
––Manage and coordinate with vendors, third parties and others to support the development, implementation, and maintenance of the compliance program
––Support other initiatives of the Office of the General Counsel as needed (Privacy, Regulatory, Legal, etc.)
– Serve as the disease area expert and providing support to cross functional team members, including onboarding and review of materials
––A minimum of 7 years of relevant experience focused on implementation of healthcare and corporate compliance programs (or specific elements) in the pharmaceutical/biotech industry (Business-side experience a plus).
––A successful track record of building partnerships with the business based on trust.
––In-depth understanding of the pharmaceutical industry with expertise in the body of laws, regulations, guidance, and codes impacting pharmaceutical companies.
––In-depth knowledge of commercial, compliance and regulatory matters related to the launch and subsequent commercialization of branded pharmaceutical products.
––Warm, genuine, approachable and pragmatic communication and working style
––Driven to partner with other functions to find the best solutions
––Risk Management (not risk avoidance) mindset
––Sense of urgency to get things done, keep things moving forward and excellent at prioritizing
––Entrepreneurial spirit and enterprise-ownership mindset
––Ability to manage projects internally and with external vendors and see through projects to completion within established deadlines
––Demonstrated leadership and strong communications skills, business acumen, and ability to make decisions efficiently
––Strong problem-solving and decision-making skills with demonstrated ability to think creatively and devise solutions to challenging problems
––Strong sense of accountability and ownership; proactive and self-motivated
––Highly collaborative; ability to work independently and as a teammate
––Curious, growth mindset, with desire to gain new experiences and contribute beyond role
––Thrives in a fast-paced, lean, highly dynamic environment
––Operate independently with autonomy and limited supervision
––Ability to travel (~20% or less)
Can travel domestically and internationally approximately 25% of the time (post-pandemic).
• Willingness and ability to travel domestically and internationally, as required.
Bachelor’s Degree. Compliance Certification or equivalent.