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Senior Manager, Compliance

Employer
Gilead Sciences, Inc.
Location
Foster City
Salary
See job description.
Closing date
Oct 16, 2021

View more

Discipline
Other, Manufacturing/QA/QC
Position Type
Full Time
Job Type
Manager
Organization Type
All Industry, Pharma


Senior Manager, Compliance
Canada - Ontario - Mississauga

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

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Working collaboratively with other members of the Legal and Business Conduct team, the individual will help support our compliance program at Gilead Sciences Canada. The individual will help develop and carry out policies and procedures; provide business conduct and compliance support to Gilead's Commercial, and Medical Affairs teams; and assist in informing training and communication plans. This role will support evaluation and assessment of Gilead's Commercial, and Medical Affairs activities in light of current laws, regulations, enforcement environment and best practices related to the marketing and sale of prescription medications. Based on this assessment, the role will help implement and execute a monitoring plan that evaluates key metrics on Gilead's compliance with its policies and standard operating procedures. Additionally, this role will work in close coordination with colleagues in Legal, Business Conduct, Commercial Operations, Medical Affairs, Internal Audit, Finance, as well as other departments to complement existing compliance activities.

Monitoring
  • Develop compliance insights to efficiently and effectively execute and support monitoring efforts across Commercial and Medical Affairs activities; support decision making across the organization based on insights;
  • Coordinate with stakeholders to ensure corrective actions have been sufficiently completed in a timely manner;
  • Interact with outside vendors to assist in the design of compliant business activities and counsel regarding the collection, analysis and reporting of monitoring metrics;
  • Responsible for independent assessment of compliance processes that may have significant impact on business operations within focus area;
  • Keep informed of external enforcement environment and recommend improvements to the company's monitoring and business conduct program based on identified industry best practices.


Compliance Reporting & Analytics
  • Develop understanding of Gilead's database reporting capabilities, including metrics Gilead possesses or can develop that reflect Business Conduct issues that may be gathered and held in Business Conduct or in other departments;
  • Analyze key compliance data sets to perform comparative analytics and trends across business activities and recommend process improvements to ensure compliance and executional efficiencies;
  • Proactively identify trends influencing Gilead's overall compliance and propose monitoring and auditing tactics to assess and evaluate the trends;
  • Provide routine analysis and reporting including ad hoc requests.
  • Support decision making by Canadian leadership team on compliance issues though delivery of compliance analysis and insights.
  • Lead and champion Business Conduct events and tactics such as compliance week, National Business Meeting Trainings, Business Conduct Manual, and Quarterly Commercial Compliance Reviews


Cross-functional Partner
  • Independently assess legal compliance issues relative to their day-to-day activities and contribute effectively to business conduct and cross functional projects;
  • Provide day to day compliance support to all functional groups at Gilead Canada to advance the Company's business conduct program and act as a business partner in providing compliance guidance and support;
  • Collaborate with other functional groups and relevant stakeholders to advance the Company's business conduct program;
  • Assist in providing day-to-day guidance, support and problem solving to internal stakeholders regarding, policy, monitoring and training issues;
  • Gather the information necessary to escalate an issue of critical importance or controversy to the appropriate levels.


Education & Experience
  • 7-8+ years of prior relevant experience in biotechnology or pharmaceutical industries
  • Experience with databases, data mining & analytical software tools
  • Demonstrated leadership and project management in cross-functional projects
  • Awareness of and relevant experience with laws, industry codes and best practices related to the promotion of prescription medications preferred (e.g., Food & Drug Act; IMC Code of Ethical Practices)
  • Demonstrated experience with laws, regulations and policies regarding pharmaceutical manufacturer interactions with Health Care Professionals


Critical Competencies
  • Must have excellent written and verbal communications skills
  • Must have excellent analytical skills and comfort with multiple data sets, with the ability to draw conclusions and make informed recommendations
  • Must have advanced Excel skills (i.e., Formulas, Pivot Charts, Pivot Tables, Formatting, etc.)
  • Intellectually curious with ability to process a great deal of information in a fast-paced environment; willing to take initiative
  • Demonstrate integrity to manage sensitive and confidential information
  • Ability to present complex information in an accurate and persuasive manner to all levels of management
  • Must have strong client service orientation and demonstrated high level of customer focus, independence and initiative
  • Should have experience working with vendors to solicit proposals, manage budgets and effectively manage a project from its initiation to delivery
  • Must be a team player who can easily handle shifting priorities, multi-tasking in a deadline-oriented environment
  • A manager should be able to independently identify the legal compliance issues relative to their day-to-day activities and will be able to identify many of the legal compliance and business issues associated with increasingly complex matters. The manager should be able to appropriately analyze these issues, begin to develop expertise in specific areas of compliance and contribute effectively to business conduct and cross functional projects
  • A manager must exhibit strong and improving judgment. Part of this judgment is demonstrated by how the manager reasons through issues and identifies those issues where the judgment of a more Business Conduct professional may be required before moving forward


Gilead Core Values
  • Integrity (always doing the right thing),
  • Teamwork (collaborating in good faith),
  • Excellence (working at a high level of commitment and capability)
  • Accountability (taking personal responsibility).
  • Inclusion (encouraging diversity)


Gilead Leadership Commitments
  • I AM BOLD in aspiration and AGILE in execution.
  • \u200bI CARE and make time for people.
  • \u200bI LISTEN, speak openly and explain the "why."
  • \u200bI TRUST others and myself to make sound decisions.
  • \u200bI OWN the impact of my words and actions.



For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.
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To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/Canada---Ontario---Mississauga/Senior-Manager--Compliance_R0021626-1





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