Responsible for the development, implementation and ongoing management of the healthcare compliance program. Establish the strategy for the healthcare compliance team within the context of RDS/RIS compliance function and larger Roche enterprise, assuring alignment of the overall compliance program with Roche Code of Conduct, legislation, regulations, and other industry dynamics. Develop and lead a high performing healthcare compliance team across RDS/RIS with a strong focus on continuous improvement of efficiency and effectiveness of the compliance program and processes.
The Compliance Director is responsible for and considered a lead for the healthcare compliance team. The individual will interact with all levels of the organization and serve as a key point of contact and functional expert for policies, HCP/HCO engagements, risk assessment, trainings, etc.
Lead a team of compliance professionals to provide healthcare compliance oversight and risk reduction for RDS/RIS. Ensure employees' compliance with Roche Group Code of Conduct and other global/local policies, relevant laws and regulations, and industry codes. The Compliance Director will envision and implement program strategies reflecting detailed understanding of our various business areas and their unique and changing risk profiles. Where necessary, draft and launch clear and concise principal-based compliance policies and guidance, provide training to employees, assist investigation of alleged business ethics incidents and performing corrective actions, and coordinate risk assessment and compliance monitoring activities. Work proactively with other departments to enable them to achieve their business goals and objectives in a compliant manner. Collaborate with Group Compliance and compliance teams across all divisions of Roche globally to assess and improve internal controls and business processes. A successful candidate will be diplomatic, curious, and capable of promoting compliance through building strong relationships with internal and external business partners both locally and around the globe.
- Provides leadership to the healthcare compliance team and is responsible for the strategic design, implementation, and effectiveness of the healthcare compliance program across RDS/RIS.
- Promote the team to be fully embedded into business and drive adoption of more efficient and effective compliance-related practices within the business to ensure compliance.
- Navigate decisions through assessing risk and pursuing collaboration, and provide pragmatic solutions by effectively integrating compliance risk/context and business knowledge to address complex problems.
- Create or improve processes, cadence, and structure to advance the reach and effectiveness of our compliance program.
- Develop training and education programs, communications strategies, plans, content, and associated materials on relevant laws and regulations, policies, guidelines, and industry codes, focusing on high risk areas and hot topics.
- Oversee investigation of business ethics incidents, transactional monitoring, and risk & opportunity assessment.
- Continue to evolve our compliance program through ensuring the appropriate practices, processes, systems and tools, such as HCP/HCO engagement approval tool, are developed, in place, and maintained to support efficient and effective execution of the healthcare compliance program.
- Proactively identify trends, dynamics, or other factors influencing overall RDS/RIS business and related compliance areas to provide forward input into future healthcare compliance plans and objectives.
- Represent the healthcare compliance team on cross-function/division/region projects and squads to drive significant impact across the organization.
- Bachelor's Degree (life sciences, law, public policy, marketing, business, education, finance/accounting or related discipline preferred).
- Graduate-level Degree preferred (JD, MBA, or related discipline).
- Certification in Healthcare Compliance (CHC) preferred.
- A minimum of 7 years' of direct compliance experience in a compliance department of a healthcare company (Diagnostics, Medical Device, Pharma/Biotech).
- At least 5 years' experience leading/transforming a strong compliance team and successfully managing and developing people.
- Knowledge of federal and state laws and industry requirements affecting the biotech/pharma/device laws.
- Specific prior experience in the development/deployment of a company-wide compliance program, including all of its elements: policy framework, Compliance operations, risk-control matrices and dashboards, training & awareness, auditing and monitoring, investigations, communications and Compliance culture/leadership
- Sophisticated ability to apply a risk-based analysis to compliance issues and demonstrate creativity and flexibility in developing solutions that satisfy both business requirements and legal obligations.
- Experience in successfully innovating compliance, embedding compliance as a key business differentiator and competitive advantage in all aspects of the business.
- Strong analytical and communication skills, attention to detail, and pragmatic and practical approach.
- Ability to work efficiently and independently, prioritize workflow, meet demanding deadlines, and manage multi-faceted projects in a fast-moving environment.
- Ability to interact positively and provide guidance within all levels of management and staff.
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Unless entitled to a reasonable accommodation under applicable law, employees are required to be fully vaccinated against COVID-19 in accordance with customer requirements, the company's health and safety obligations and/or applicable law or guidelines.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
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