Healthcare Compliance Office (HCO) Program Ops Manager - Program Operations

Roche•South San Francisco, CA

9d•$111,790 - $207,610•Onsite

About The Position

The Program Operations Compliance Manager will play a critical role on the HCO team at Genentech. This role is responsible for operational elements and compliance guidance and reviews for external funding requests (e.g., grants, exhibits, sponsorships, corporate memberships), Advisory Boards, fair market value (FMV), and other areas of business need as assigned, including ensuring adherence to and oversight of applicable Genentech processes and guidelines. The role requires an individual with strong subject matter expertise on state and federal laws on interactions with healthcare professionals, a strong operational mindset to redesign workflows, eliminate bottlenecks, and actively implement cutting-edge technologies—including AI and automation—and ability to develop an in-depth understanding of Genentech’s policies, requirements, processes, and procedures.

Requirements

Impeccable ethics.
Demonstrates, or has proven abilities to demonstrate, Roche Values and Leadership Commitments
Adept at identifying operational friction and leveraging modern technology—including automation and AI—to redesign workflows, eliminate bottlenecks, and drive organizational efficiency.
Strong verbal and written business communication skills: highly adept at synthesizing and summarizing complex and/or voluminous content into clear, concise and actionable communications, including balancing use of AI tools and human confirmation
Works well within teams
Effectively identifies, develops and implements scalable/sustainable process and other continuous improvements to achieve organizational efficiencies and increase effectiveness
Experience building and cultivating relationships with key partners and stakeholders across organizational levels
Thinks “outside of the box” for solutions.
Applies creative problem-solving and develops appropriate business solutions to effectively address compliance risk
Brings strong operational expertise and program management skills to HCO, with a proven ability to prioritize multiple tasks, projects, and goals.
Demonstrates complete, end-to-end ownership of initiatives to ensure the timely, on-target, and within-budget delivery of outcomes, while continually identifying and implementing process improvements
Demonstrates ability to gain a deep understanding of business operations, including proven ability to connect operational changes to the broader organizational strategy and anticipate downstream impacts.
Consistently leverages strong organizational navigation skills to guide complex initiatives to successful completion
Demonstrates ability to identify appropriate resources.
Exercises good judgment in terms of when to leverage internal resources, including approved artificial intelligence tools
Can effectively drive discussions and decisions toward desired end-results
Bachelor's Degree (life sciences, law, public policy, marketing, business, education, finance/accounting or related discipline preferred).
3 or more years of work experience gained in the pharmaceutical, biotechnology, management consulting, or other regulated industry.
Healthcare Compliance Certification (before or w/in 6 months of start date)
Must demonstrate in-depth knowledge of the bio/pharma industry (compliance, legal, medical affairs, sales, and product marketing)
Must demonstrate in-depth knowledge of the legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry (includes anti-kickback statutes, healthcare fraud & abuse, off-label promotion, PhRMA Code, etc.)

Nice To Haves

Familiarity with funding related preventative and detective controls in the pharmaceutical industry
Experience serving as an advisor on or developer of key operational practices, processes, or procedures
Experience in compliance disciplines (privacy, healthcare auditing and monitoring, transparency) a plus

Responsibilities

Serve as a business owner for Funding Operations and/or Advisory Board Operations systems; navigation within these systems and compliance review of funding requests may be up to 80% of the role for an extended period.
Perform compliance review and approval and appropriately process external funding requests based on relevant Genentech processes, guidelines, and SOPs.
Broadly understand relevant healthcare fraud and abuse regulations and maintain ability to adapt to changes, both active and pending, that will impact or influence the work of Genentech.
Ensure consistency with and adherence to Genentech standards, laws, regulations, and policies that govern the conduct of the Genentech activities in the remit of this role.
Lead operational governance across Program Operations’ areas of accountability, providing ongoing guidance to internal stakeholders.
Provide customer service and guidance to external organizations regarding the grant application process and pending grant requests.
Drive co-ownership of operational elements and compliance with cross-functional internal stakeholders for the processes in Program Operations’ areas of accountability.
Working with the end-user in mind, drive modernization of operational processes by evaluating current workflows, designing streamlined alternatives, and partnering with technology teams to successfully implement tools, including automation and AI solutions.
Actively pursue continuous professional growth and the development of new skills through formal education, hands-on experience, or other acceptable means, utilizing Genentech's provided resources for education and professional development.
Comply with all laws, regulations, policies and procedures that govern the conduct of Genentech activities.
Supporting other duties and projects in functional areas such as operations, monitoring, auditing, investigations, policy, training, iHCP, FMV and transparency, as needed.