Genentech's Commercial Compliance Operations (CCO) group, part of the broader Commercial Business Operations (CBO) organization, designs, implements, and owns business processes and systems needed to maintain compliance with state and federal laws and Genentech policies governing our interactions with healthcare professionals (HCPs) and related entities.  The Transparency and Aggregate Spend Operations arm within CCO is principally responsible for tracking, monitoring, managing and reporting on Genentech's overall aggregate spend with the healthcare community to achieve transparency as defined by the Healthcare Compliance Office (HCO).  To support this work, the group owns the Aggregate Spend Management system and related tools which provide automation and processes to enable the aggregating, self-monitoring, corrective action and internal and external reporting for transparency requirements.  The group also owns and maintains processes for Fair Market Value payments to physicians, speaker program compliance, vendor registration for field personnel, and other processes supporting healthcare compliance.  

In addition, the group serves as an important conduit with the rest of the Commercial Operations organization to ensure a culture of compliance through well-thought out, actionable and achievable compliance processes.  Given the nature of this group's work, they communicate and interface with a host of internal cross-functional partners, both within Commercial and with IT and other Genentech functions, and develop and implement business processes, systems and tools to support fully compliant and efficient management and reporting associated with Genentech's aggregate spend program. 

CCO Specialists track, monitor, manage and report Genentech's aggregate spend with Healthcare Professionals (HCPs) and organizations, as well as play an active role in the development of associated business processes, systems and tools.  They employ a variety of data analysis techniques and direct junior team members in doing so, and distill analyses into useful information that helps drive business decisions. CCO Specialists also work with their manager in developing training/development programs and initiatives for CCO, preparing and delivering senior management presentations on strategic or complex issues and leading strategic projects.  Incumbents in the CCO Specialist, role, as all other employees, are fully accountable for compliance with all laws, regulations and policies that govern the conduct of GNE activities. As a leader in the compliance area, the CCO Specialist demonstrates full knowledge and commitment to all applicable policies, monitors adherence to company policies and guidelines and acts according to established procedures to ensure all issues are addressed and resolved as required.

Key Accountabilities: 

Commercial Compliance Operations Specialists are generally expected to: 

• Stay abreast of relevant laws and regulations that affect organizational spending with HCPs and healthcare related organizations; and play an active role in educating and keeping others internally abreast regarding such laws and regulations 
• Model compliance with HCP laws and regulations across the Genentech organization 
• Expertly and efficiently comply with all state and federal laws and regulations regarding organizational spending with HCPs and healthcare related organizations; ensuring all relevant data and data reporting fully meets all relevant laws and regulations, including accuracy and on-time reporting 
• Play a proactive role in helping identify, recommend, develop and implement departmental policies, procedures, systems, methodologies, templates and other tools to effectively and efficiently track, monitor, measure and report on Genentech’s aggregate spend with HCPs 
• Use advanced techniques in data modeling, data mining, database operations design, process analysis, gap assessment, problem solving and solution design
• Effectively support development, management and maintenance of Commercial’s Aggregate Spend Management and Genentech Funding Request systems 
• Work collaboratively and effectively with all internal, and any external, partners and stakeholders 
• Effectively support his/her manager and the overall department by developing and implementing training & development programs for CCO, preparing and delivering presentations on strategic or complex issues and leading special projects 
• Act in complete & total compliance with all laws, regulations and policies 
• Participate, as and when needed/appropriate, in cross-functional or other project teams; helping the overall business of Genentech to continuously evolve, improve and excel 

Compliance, Knowledge & Skills

• Follows all laws, regulations and policies that govern the conduct of all activities. Is accountable for being fully knowledgeable of all relevant policies and for abiding by these
• Does not compromise ethics or integrity, or undertake legal risks while pursuing business goals
• Asks questions when in doubt
• Demonstrates leadership among peers by consistent application and modeling of the appropriate compliance, behavior and conduct
• Where applicable, is required to obtain and maintain full proficiency and knowledge of disease state, product and other aspects or issues as provided for and mandated by the company

Planning & Development

• Stays abreast of relevant laws and regulations that affect organizational transfer of value
• Acts as a lead subject matter expert on data sources, analytical methodologies, and reporting requirements, as well as related business processes, systems, templates and other tools
• Works with his/her manager, peers and other internal partners such as Legal and HCO and plays a lead role in the development, setting and implementation of relevant internal policies and procedures that govern internal business practices and operations in relation to HCP spending
• As appropriate, participates in Commercial Operations and other Non-Commercial Operations business planning processes; proactively monitoring and recommending on HCP spending and compliance with internal business partners and stakeholders
• Performs data analyses and modeling to support internal business partners and other stakeholders in their business planning processes
• Keeps internal business partners and stakeholders apprised of evolving legislation and regulations regarding HCP spending and compliance
• As appropriate, conducts internal education/training sessions with internal business partners and/or other stakeholders
• Works with manager and other team members to regularly assess analytical methodologies and practices, data sources, data monitoring and mining systems, other business processes, relevant systems and tools. Plays a leadership role in:
• • Identifying and recommending process improvements or other opportunities to streamline and improve overall compliance and efficiencies
  • Collaborating with various cross-functional groups to assess broader business intelligence needs
  • Researching new data sources and analytical methods
  • Developing new vehicles for presentation of data findings
  • Developing analytical capabilities and processes for regular and ad hoc analyses and reporting
  • Integrating design across multiple Genentech databases and other information platforms for streamlined and accurate data
  • Developing Standard Operating Procedures (SOPs) and/or Department Operating Procedures (DOPs)
• Leads special projects, as assigned, potentially working with a host of internal business partners or stakeholders 
• As assigned, may act as project lead for planning and development of CCO systems. Conducts requirements' gathering, may lead planning and development sessions, and project manage systems updates or other enhancements, which may involve regular interface and liaison with Information Technology
• Develops and disseminates a calendar of regular reporting required to support HCP spending compliance

Operations

• Performs routine and ad hoc data mining and modeling to ensure accurate and up-to-date HCP spend information is available at all times
• Manages aggregate spend data and performs routine and ad hoc data tracking, monitoring, measuring and reporting on Genentech's aggregate spend. Responsible, at all times, to ensure transparency reporting is fully accurate and on-time to meet external regulatory reporting requirements:
• • Applies structured and disciplined methodologies, programs and applications for analyzing, presenting and reporting spend data
  • Demonstrates strong abilities to define problem statements and enhance existing methodologies, as appropriate, for state and federal reporting needs
  • Clearly identifies process gaps and inefficiencies
• Responsible for proactively elevating any issues, concerns or potential risks of non-compliance to his/her manager. Recommends opportunities or actions to mitigate and/or otherwise address potential risks of non-compliance
• Attends various internal business partner/stakeholder meetings to stay abreast of, at all times, internal business plans, objectives and activities associated with transparency requirements. Provides expert insights and recommendations to business partners/stakeholders to help to assure Genentech's operations remain, at all times, in full compliance with relevant state and federal laws and regulations
• Responds to inquiries or other requests in a timely manner. Includes guiding internal business partners on their continued compliance and supporting HCO on state reporting regarding HCP spending
• Where assigned, adheres to priority scheduling, quality and strict timelines for maintenance, updates or other changes to CCO systems
• Conducts internal business presentations, as and when appropriate
• Supports his/her manager in quarterly business planning processes. Including helping to gather and prepare all relevant data and presentations, as well as conduct various business presentations
• Completes  other administration, as and when needed, assigned or requested 
• Attends team/departmental and other meetings. Prepares in advance and actively engages to share information, convey business updates and the like; also uses to learn of activities undertaken by others and best practices 

Cross-Functional/Project Support/Participation & Personal Development 

Supports, as and when assigned, on wider goals/objectives or projects.  As such, may act on cross-functional teams assigned with a specific mission or role, and may be asked in such capacity to represent the CCO Specialist position specifically or for other, specific activities. In addition, is expected to recommend appropriate opportunities to participate on various teams, and/or complete special projects that will help further the success of CCO, the broader TLS/CCO group, Commercial Operations or Genentech overall. 

Actively identifies and participates in various training & development programs and other offerings, groups or activities that will enable continued development of his/her technical skills as well as product and business knowledge.

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