1+ months

Compliance Manager, HCO

Roche
South San Francisco, CA

Healthcare Compliance Office (HCO) Compliance Manager

The Healthcare Compliance Office offers coordination and oversight for all healthcare compliance matters at Genentech and is responsible for the following key areas: Privacy, Compliance Policy Development; Compliance. and Ethics Training & Communications; Auditing; Monitoring and Investigations. As part of its mission to better serve the organization, all members of the HCO team are expected to develop both the their depth and breadth of their expertise in one or more of these areas.

RESPONSIBILITIES:

  • Develops and maintains an in-depth understanding of Genentechâs business, organizational structure, reporting relationships, core business practices, policies & procedures, as these relate to healthcare compliance and ethics
  • Plays role in proactive research, evaluation and 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 & policy guidelines
  • Contributes to annual Work Plan development and implementation
  • Effectively integrates compliance risk/context and business knowledge to address complex problems across all HCO functions
  • Keeps current in the area of healthcare compliance and ethics. Proactively identifies and addresses compliance issues
  • Has ability to create policy changes and pull through to develop relevant training as required
  • Recommends new or amended healthcare and related compliance and ethics policy statements to HCO and cross-functional leadership, partners and other stakeholders. Includes specifying actual or potential implications to existing business operations, procedures and practices
  • Leads and/or participates, with limited direction, in complex cross-functional internal committees charged with reviewing, creating, updating and maintaining Genentech compliance, ethics and related role-based compliance manuals.
  • Acts as a point-of-contact for 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
  • Assists, with limited direction, execution of the compliance training plan and developing training content
  • Helps others apply laws and regulations correctly and ensure consistent adherence. Is relied upon for sound compliance guidance and applies a strategic approach to problem-solving
  • As assigned, assists with other HCO duties and/or projects including but not limited to matters related to operations, privacy, audit and transparency areas.
  • Where applicable, manages outside vendors to ensure on-time, on-target and within-budget deliverables.

REQUIREMENTS:

  • Has impeccable ethics. Demonstrates, or has proven abilities to demonstrate, Roche Values & Leadership Commitments
  • Strong verbal and written business communication skills: highly adept at synthesizing and summarizing complex and/or voluminous content into clear, concise and actionable communications
  • Works well within teams
  • Strong process-orientation: has proven effectiveness in identifying, developing and implementing scalable/sustainable process and other continuous improvements to achieve organizational efficiencies and increase effectiveness
  • Strong influencing skills: proven track record and experience building and cultivating relationships with key partners and stakeholders across organizational levels
  • Thinks âœoutside of the boxâ for solutions. Applies creative problem-solving and appropriate business solutions to effectively address compliance risk
  • Excellent project management skills: can prioritize multiple tasks and goals to ensure timely, on-target and within-budget accomplishment of such
  • Demonstrates ability to identify appropriate resources. Exercises good judgment in terms of when to leverage internal resources
  • Strong business acumen: understands how the business âœworksâ and demonstrates consistently effective âœnavigationâ across the organization
  • Strong negotiation skills: can effectively drive discussions and decisions toward desired end-results
  • Must demonstrate in-depth knowledge of the bio/pharma industry (compliance, legal, clinical affairs, 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, government fraud & abuse, off-label promotion, PhRMA Code, etc.)
  • Experience in other compliance disciplines (privacy, healthcare auditing and monitoring, transparency)a plus
  • Ability to travel
  • Bachelors Degree (life sciences, law, public policy, marketing, business, education, finance/accounting or related discipline preferred)
  • Graduate-level Degree preferred (JD, MBA, MEd or related discipline)
  • Healthcare Compliance Certification (before or w/in 6 months of appointment)
  • 6 or more years of work experience in legal, compliance, policy, auditing, training, communications or related discipline in the bio/pharma 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
Posted: 2018-10-16 Expires: 2018-12-27

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Compliance Manager, HCO

Roche
South San Francisco, CA

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