Experienced, visionary and strategic Chief Compliance Officer (“CCO”) in the healthcare industry (Diagnostics, Medical Device or Pharma/Biotech) to architect, integrate, manage and oversee the compliance program at Roche Diagnostics Corporation (“RDC”) and Roche Diagnostics Operations (“RDO”). This role will elevate, drive and ensure full implementation of the 7 elements of an effective Compliance program as set forth by the US Department of Justice and also re-set the vision and strategy for the function in the US within the context of the larger Roche enterprise, shape and influence the organization’s strategy, augmenting collaboration and synergies, co-creating and developing Compliance policies, practices, culture, education and awareness, and evaluate and manage risk.
The role also involves conducting periodic evaluations of RDC’s enterprise risks and its progress with risk management activities and is responsible for developing a robust Compliance program that not only meets current needs, but predicts and mitigates future risks as well As a proactive leader, the CCO will collect risk data and analyze the information, creating opportunities for proactive – rather than reactive – responses
The CCO will lead and develop a team of Compliance associates with responsibility for executing the common vision and strategy for US Compliance. The senior-level advisor will lead the Compliance Committee, involve interaction with management at the most senior level and with the US Executive Team as well as Roche Global senior functional stakeholders, product and compliance teams. The successful candidate will have extensive experience in successfully overseeing broad-based compliance programs in the US and overseeing a small to medium size compliance organization, preferably as a Chief Compliance Officer. This role is currently based in Indianapolis, Indiana and reports to RDC/RDO General Counsel.
Sophisticated Risk Management
Key leader responsible for safeguarding the reputation of RDC and RDO
Lead Compliance Committee
Provides leadership, direction, and integration of compliance activities to fulfill state and federal regulations. Overall responsibility for the design, implementation and effectiveness of the compliance program across the company based on the 7 elements of an effective Compliance Program set forth by the Department of Justice.
Responsibility for all Compliance policies, including drafting, revising/updating and implementing.
Oversee periodic enterprise risk management evaluations intended to identify, assess, monitor and mitigate risks that may affect RDC generally, so they are managed within acceptable risk tolerance levels.
Leading and developing a high performing compliance team that is execution focused and disciplined in approach.
Working in strong partnership with other Roche compliance officers and business teams to create a consistent and effective US compliance program for RDC and RDO within the larger Roche enterprise.
Serving as a technical resource for business and other functions regarding compliance and/or regulatory matters. • Evaluating the company’s products, services and operations for compliance and ethics issues.
Accountability for all company Compliance government disclosures, including submission of the yearly Sunshine Act report
Maintaining a thorough understanding of, and keeping abreast of developments in, healthcare laws and regulations in the US that pertain to RDC’s products and services.
Interpreting new laws/regulations and developing a strategy to follow such laws/regulations within the required regulatory timeframe.
Mentoring local and global compliance professionals on their work and management activities and their career development and goals.
Promoting a culture of compliance by fostering an environment of open and honest communication with all employees of all levels –reinforcing the importance of conducting oneself in an ethical manner and in the best interests of the company.
Developing and driving the implementation of a proactive, strategic and modern training program throughout the organization aimed at impacting behavior and driving ownership of Ethics and Integrity by all associates.
Driving operational efficiencies by setting measurable goals and working on leveraging and deploying new and existing technologies to improve efficiencies in the compliance programs across the organization.
Preparing materials and making presentations to RDC and RDO senior management or their staff as requested.
Preparing materials and making presentations to the Roche Global Compliance Leadership or other committees about compliance/regulatory matters.
Representing RDC with US regulators and overseeing the interactions with such regulators, including the FDA, DOJ, OIG with regard to compliance matters, inquiries or investigations.
Leading internal investigations to conclusion and management of the internal Compliance employee hotline. • Assisting the General Counsel in ensuring alignment of Compliance and legal advice and consistency of counsel across business units in the organization.
Assisting General Counsel in formulating departmental structure, vision and goals, including career development and retention planning for attorneys and Compliance associates and members of the Legal Department.
Studying major areas of concern to the organization from a risk mitigation perspective and recommending changes in policies and procedures.
Studying major areas of opportunity in the way we conduct business to ensure our policies are fit-for-purpose and empower the business to act with confidence
Coordinating and closely collaborating with subject matter expert and global Compliance and Legal colleagues to facilitate achievement of U.S. business goals in a sustainable way and position Ethics and Compliance as a competitive advantage.
Who you are:
10 years’ of direct compliance experience in a Compliance department of a healthcare company (Diagnostics, Medical Device, Pharma/Biotech)
5 years’ experience leading/transforming a strong Compliance team and successfully managing and developing people
B.S. or B.A. degree
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
Extensive knowledge of federal and state laws and industry requirements affecting the biotech/pharma/device laws and experience implementing legislative changes into the program components
Proven track record of successfully building and leading a Compliance function in large, matrixed organizations that embeds Compliance as a competitive advantage and strategic business enabler of long-term growth
Proven track record of successfully innovating in Compliance, embedding Compliance as a key business differentiator and competitive advantage in all aspects of the business
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
Specific experience presenting to and working directly with company CEO, CFO, Head of Sales, Head of Regulatory Affairs and other C-suite members
Strong analytical and communication skills
Strong attention to detail. Pragmatic and practical approach. Decisive and direct
Appropriate level of assertiveness, maturity, self-awareness, courage, agility and guidance to effectively project the stature and importance of the compliance function across the organization
Excellent collaboration and influencing skills
Superior judgment and rigor in relation to problem solving and appropriate escalation of issues
Demonstrated ability to work efficiently and independently, prioritize workflow, meet demanding deadlines, and manage multi-faceted projects in a fast-moving environment
Willingness and ability to deliver a consistent message in the face of adversity
A demonstrated ability to establish and maintain open and trusting work relationships