Principal Healthcare Compliance Manager, Healthcare Compliance Office, Compliance Operations & Training
Duties and Responsibilities
- Provides subject matter expertise on compliance and risk management issues and topics and provides knowledge, skill, and problem-solving capabilities to intermediate- or advanced-level compliance and regulatory challenges.
- Has regular interactions with senior leaders and influences development of long range plans for the organization; decisions have significant impact on own function and related functions
- Contributes expertise and insights into ongoing development, refinement and implementation of healthcare compliance, ethics and related policies, guidelines, and Standard Operating Procedures (SOPs) healthcare compliance training and communications strategies, plans, content and associated materials
- Coordinates with the Healthcare Compliance Advisors (HCAs) to ensure knowledge transfer and integration and consistent understanding
- Responsible for implementation of HCO Policy & Training Strategy and delivery
- Serves as a training expert to HCO by identifying current gaps in training content and strategy, creating implementation plans and managing stakeholders.
- Owns, develops and delivers complex training (including live, virtual and e-learning formats) across several functional or business areas that drive role effectiveness for the targeted audience.
- Ensures that all healthcare compliance training designed and delivered are fully aligned with Genentech’s standards, operational objectives and compliance culture.
- Evaluates the effectiveness of the healthcare compliance training programs, delivery methods, content and training materials.
- Delivers live compliance trainings in group settings
- Works with HCO team to pull through policy changes to develop relevant training as required
- 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
- Contributes to annual and longer-range HCO Risk Assessment Plan and Work Plan development and implementation
- 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 Genentech’s overall healthcare and related compliance to provide forward input into future HCO plans and objectives
- Assists with implementation of compliance oversight of the company’s federal and state transparency reporting and timely submissions; coordinating across Genentech, Global Functions and ex-US affiliates
- Assists to ensure US HCO’s obligations to review iHCP requests by ex-US affiliates and functions are met
- Operates with a high degree of flexibility and interactivity in support of an agile-based, sprint-oriented model of business responsiveness
- Represent department on moderately complex departmental programs, cross functional projects and other deliverables
- Exercises significant latitude in determining objectives and approaches to assignments.
- Develops, maintains a strong understanding of current legislation and regulations that pertain to healthcare and privacy compliance and ethics for bio/pharma industry organizations
- Develops and maintains a solid understanding of Genentech’s business, organizational structure, reporting relationships, core business practices, policies & procedures, as these relate to healthcare compliance and ethics
- 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
- Acts as a coach for colleagues with less experience and helps them develop skills/expertise.
- May provide guidance and manage work activities of other staff members for specific projects or objectives.
- As assigned, assists with other HCO duties and/or projects.
- Where applicable, manages outside vendors and/or counsel to ensure on-time, on-target and within budget deliverables
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 problem
- Establishes Strong Collaborative Relationship: 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 and working across the compliance network
- 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 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 of experience with JD; or
- 12 or more years of experience with 10+ years of work experience in legal, compliance, policy, auditing, training, communications or related discipline in the bio/pharma/DIA industry
- 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.)
- Bachelor degree required (life sciences, law, public policy, or related discipline preferred)
- Graduate-level Degree preferred (JD, MBA, MS, PharmD or other PhD, or related discipline)
- Healthcare Compliance Certification (before or w/in 6 months of appointment)
- Based in South San Francisco
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 South San Francisco, California is $169,800 to $315,300. 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.
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