South San Francisco, California, United States of America
12 hours ago
Compliance Management - Affiliate
The Position

RESPONSIBILITIES 

Reports into the Deputy Healthcare Compliance Officer and will play a critical leadership role at Genentech as a player/coach

Primary responsibility for  the development, implementation, maintenance, and refinement of strategic operations for Funding Review and Advisory Board Operations, HCP, Patient, and Social Medial Influencer Fair Market Value (FMV) Operations, and iHCP Review Operations 

Leads development, refinement, and adherence to HCO’s Service Level Agreements (SLAs) for Funding Review & Advisory Board Operations, HCP, Patient, and Social Media Influencer FMV Operations, and iHCP Review Operations

Responsible for hiring, onboarding, coaching, development and engagement of a program operations team that executes core operational aspects of our corporate compliance program, compliance monitoring, and governance; similarly, manage the work outputs of operations team, external vendors and partners as necessary to ensure work is delivered on-time, within budget, and is delivered to the quality expectations set forth by Genentech

Acts as functional lead for the areas above to manage, oversee and enhance program operations team performance through reports and data analyses; guide program operations team through escalations, complex issues, and long-term strategic planning; provide ongoing guidance to internal business stakeholders; 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

Accountable decision maker for all escalated funding requests and exceptions, managing communications with senior leaders regarding denied funding applications

Accountable decision maker for exception requests related to the internal fee/rate schedule for HCPs, Patients, and Social Media Influencers 

Secondary reviewer and accountable decision maker for all funding requests of a certain dollar amount and entity type

Responsible for evaluating results of a legal assessment and the implications to funding approval decisions

Ensures alignment within HCO and across the business on compliance related matters and decisions

Responsible for leading large and/or highly complex departmental programs, cross functional projects, and other deliverables

Exercises wide latitude in determining objectives and approaches to assignments and consistent understanding 

Ensures consistency with and adherence to Genentech standards, laws, regulations, and policies that govern the conduct of Genentech activities.  Complies with all laws, regulations, policies and procedures that govern the conduct of Genentech activities.  

Proactively identifies trends, dynamics or other factors influencing HCO plans and objectives

Collaborates with legal and business partners and others within Compliance to identify and understand business priorities; contributes to annual and longer-range HCO Risk Assessment Plan and Work Plan development and implementation

Identifies and communicates to partners the key accomplishments and Work Plan progress throughout the year, including compliance committee discussions

Challenges status-quo and effectively integrates compliance risk/context and business knowledge to address unusually complex problems

Represents department on cross-functional review/decision-making committees of significant impact across the organization 

Creates and enables a formal network of senior leaders, experts and key decision makers to directly or indirectly influence others to achieve results in a complex environment. 

Broadly develops, maintains and shares in-depth understanding of Genentech’s business, organizational structure, reporting relationships, core business practices, policies, procedures, as they relate to healthcare compliance and ethics

Broadly develops, maintains and shares in-depth understanding and mastery of current legislation and regulations that pertain to healthcare compliance and ethics for bio/pharma industry organizations

Responsible for accurately forecasting project timelines and budgets and managing the same.

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

EXPERIENCE

10 or more years experience with JD

7+ years direct experience in a legal or corporate compliance group in the bio/pharma/DIA industry 

15 or more years of experience without a JD 

10+ years direct experience in a legal or corporate compliance group in the bio/pharma/DIA industry 

5+ years of people management experience and/or leading teams on projects, including responsibility for guiding, mentoring, and coordinating the work of others

Extensive experience in significant kickback risk issue spotting and analysis

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.)

QUALIFICATIONS

Bachelor degree required (life sciences, law, public policy, or related discipline preferred)

JD preferred

Healthcare Compliance Certification (before or w/in 6 months of appointment)

Based in South San Francisco

Ability to travel


 

CAPABILITIES/SKILLS

Has impeccable ethics  

Leadership: has strong cross-functional team leadership skills and has excelled as a cross-functional team leader; consistently 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 relationships; fosters an exchange of ideas and support amongst colleagues.  Works effectively with other people over whom he or she has no direct authority

Decision Making: consistently demonstrates independent good  judgment and effective decision making skills even in the face of ambiguous circumstances or contradictory requirements; 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; expertise in dealing with different stakeholders across the enterprise and working across the compliance network

Business Acumen: understands how the business “works, its landscape and its future direction; proactively integrates business knowledge with compliance analysis to enable desired business outcomes

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 expert knowledge and exceptional ingenuity in strategic problem solving to deliver advanced solutions

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 exceptional 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; highly 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

Thinks “Outside of the Box” for Solutions: develops solutions to frequently unique challenges of unusual complexity which require a high degree of creativity and innovativeness to effectively address compliance risk and may serve as precedent for future decisions.

The expected salary range for this position based on the primary location of California is $207,600 - $385,500.  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.

Benefits

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.

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