Principal Healthcare Compliance Manager, Healthcare Compliance Office Advisory
Duties and Responsibilities
● Healthcare Compliance Advisor (HCA)/Single Point of Contact (SPOC): Acts as
primary consultant for multiple business or functional units; has full strategic
responsibility to work across compliance ecosystem and for understanding business priorities, advising, and assessing and/or developing compliance policy, guidelines, Standard Operating Procedures (SOPs), business guidance and training and communications that cover multiple complex risk areas of significant
impact; spokesperson for the organization on significant matters pertaining to policies, programs, practices or objectives
● Has regular interactions with senior leaders; influences development of long range plans for the organization; decisions have significant impact on own function and related functions
● Proactively researches, evaluates and provides recommendations associated with evolving healthcare and related compliance and ethics legislation and regulations. Includes benchmarking and staying abreast of other industry and marketplace developments and best practices and determining requirements for Genentech policies
● Influences development of overall objectives and long range goals of Genentech
● Acts as a point-of-contact for questions about healthcare, ethics and related
compliance statements. Includes responding to inquiries and providing guidance on compliance and resources to support business operations, team and individual adherence
● Collaborates with legal and business partners and others within Compliance to identify and understand business priorities; contributes to annual and longer-range Healthcare Compliance Office (HCO) Risk Assessment Plan and Work Plan development and implementation
● Operates with a high degree of flexibility and interactivity in support of an agile-based, sprint-oriented model of business responsiveness
● Represents department on cross-functional review/decision-making committees of significant impact across the organization
● Challenges status-quo and effectively integrates compliance risk/context and
business knowledge to address unusually complex problems
● Develops relationships with Genentech personnel across functions and teams and provides healthcare compliance policy guidance and solutions as needed
● Proactively identifies trends, dynamics or other factors influencing HCO plans and objectives
● Leads or participates in large and/or complex departmental programs, cross functional projects and other deliverables
● Exercises significant latitude in determining objectives and approaches to assignments
● Develops, maintains and shares a strong understanding of current legislation and regulations that pertain to healthcare compliance and ethics for bio/pharma industry organizations
● Develops and maintains a strong understanding of Genentech’s business,
organizational structure, reporting relationships, core business practices, policies & procedures, as these relate to healthcare compliance and ethics
● Acts as a coach for colleagues with less experience and helps them develop
● May provide guidance and manage work activities of other staff members for specific projects or objectives.
● Advise Roche global partners on US changes or other evolutions and Genentech’s strategy and plan to address these. As appropriate, works with global partners to incorporate new or amended Genentech healthcare compliance, ethics and related policies into Roche global information
● As assigned, assists with other HCO duties and/or projects.
● Where applicable, manages outside vendors to ensure on-time, on-target and
Skills and Competencies
● Has impeccable ethics
● Leadership: has strong cross-functional team leadership skills and has excelled as a cross-functional team leader; regularly demonstrates the ability to deliver results both through self and others; challenges status-quo and develops new approaches to complex problems potentially influencing others to change their point of view and leading others to solve problems
● Establishes Strong Collaborative Relationships; fosters an exchange of ideas and support amongst colleagues, co-workers, key partners and stakeholders; works effectively with other people over whom he or she has no direct authority
● Decision Making: regularly demonstrates independent good judgment and effective decision making skills even in the face of ambiguous circumstances or contradictory requirements more than 50% of the time in matters of significance; presents a compelling case and facilitates effective and expeditious decision-making
● Compliance Acumen: recognized internally as an expert in one’s own job discipline. Has deep skills and expertise across multiple disciplines in the field; expertise in dealing with different stakeholders across the enterprise and working across the compliance network
● Business Acumen: understands how the business “works” and presents a compelling case and facilitates effective and expeditious decision-making
● Enterprise Thinking: understands the implications of compliance support and advice on business projects and teams beyond the current environment; influence teams toward achievement of annual and longer-range strategic goals and objectives demonstrates ability to apply advanced knowledge and establish solutions to address strategic and problems
● Strategic Agility: articulates wise, long-term objectives and strategies; provides focus and direction to successfully navigate complexity and uncertainty. Links his/her responsibilities with the mission of the whole organization. Focuses on activities that provide the most value to the HCO and organization.
● Technical and Business Expertise: demonstrates strong ability to read, analyze (i.e., issue spot) and interpret business, compliance and regulatory information and legal advice; demonstrates ongoing commitment to reduce complexity across the organization
● Verbal and Written Communication Skills; adept at synthesizing and summarizing complex and/or voluminous content into clear, concise and actionable communication; encourages direct and open discussions about important issues, and is able to eliminate churn and drive toward clarity
● Process Orientation: demonstrates effectiveness in identifying, developing and
implementing scalable/sustainable process and other continuous improvements to achieve organizational efficiencies and increase effectiveness
● Project Management Skills: strong ability to prioritize multiple tasks and goals to ensure timely, on-target and within-budget accomplishment of such deliverables.
● Thinks “Outside of the Box” for Solutions: develops solutions to complex challenges requiring regular use of ingenuity & innovation to effectively address compliance risk consistent with organizational objectives
● 7 or more years experience with JD; or
● 12 or more years experience with 6+ direct experience in a legal or corporate
compliance group in the bio/pharma/DIA industry advising or leading project teams in design, development and implementation of elements of a corporate compliance program or projects with significant organizational impact
● 4 or more years of previous experience leading large-scale cross-functional project teams or other forums in design, development and implementation of policies, programs or projects with significant organizational impact
● Demonstrated in-depth knowledge of the bio/pharma/DIA industry (compliance, legal, clinical affairs, and product marketing)
● Demonstrated in-depth knowledge of the legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma/DIA industry (includes anti-kickback statutes, government fraud & abuse, off-label promotion, PhRMA Code, etc.)
● Previous experience in federal and state transparency reporting a plus
● Bachelor degree required (life sciences, law, public policy, or related discipline preferred)
● JD strongly preferred
● Healthcare Compliance Certification (before or w/in 6 months of appointment)
● Based in South San Francisco
● Ability to travel
How to Apply
Relocation benefits are not available for this job posting.
The expected salary range for this position based on the primary location of California is $169,750 to $315,250. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.
Link to apply here.
Job Bank Sponsorship Opportunity
Each quarter, one law firm and one company will have the opportunity to show their support for diversity in the legal profession and help advance the careers of attorneys of color by becoming a CMCP Job Bank Sponsor.