Provide healthcare compliance leadership and/or support of various US Oncology client groups, including cross-functional, intra and inter business unit pro-grams, teams and operations groups. Support the implementation of our ethics and compliance program, with emphasis on: policies, training, auditing, monitoring, risk assessments
Foster OBU culture of high integrity, and ensure adequate programs to man-age compliance and reputational risks, while striving to drive competitive ad-vantages.
Provide quality and timely corporate compliance and healthcare compliance advice to colleagues at various levels throughout the OBU
Anticipate changes in the external and internal environment and support the development and implementation of appropriate policies and standards.
Work collaboratively with Novartis E&C colleagues outside of the OBU as appropriate (e.g., US Pharma E&C; Global Oncology I&C)
Assist Oncology E&C in the development of a quality management platform to support business led oversight of activities such as: vendor oversight, di-rect to patient interaction, assessments and self-inspections.
Work collaboratively with cross-functional Business Partners to develop and implement quality management systems to ensure adherence to NPC policy, procedures and law and improve project execution.
Conduct field- and HQ-based programmatic and ad hoc compliance auditing and monitoring.
Support risk assessment, root cause analysis and other business-led monitory processes designed to enhance compliance risk awareness and mitigation strategies.
Serve as deputy to Lead E&C Advisor for the assigned Governance board or other like-functioning body charged with oversight and approval of projects, materials, events, etc pertaining to the respective Franchise or client group.
Key Performance Indicators:
Compliance with all regulatory obligations and Novartis policies
Effective operational management aligned with business demands.
Trust built with all legal and E&C stakeholders demonstrated by engagement and feedback
Ensuring strategic alignment of policy
Novartis seen as a credible, ethical and preferred partner
Quality/speed of advice provided to resolve issues, including consistency of advice (requiring strong collaboration across E&C and with BU Legal partner)
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Bachelor's Degree or equivalent 4 Year University Degree required
Advanced degree, preferred
Completion of relevant certification program, preferred (e.g., Seton Hall Healthcare Compliance Certification, CCEP, CHC)
- 5 plus years experience in the pharmaceutical industry
- In depth understanding of the operations of a pharmaceutical company including medical affairs, marketing, and sales.
- Strong knowledge of relevant regulatory/compliance requirements (e.g., Federal HealthCare Program and FDA laws, regulations, codes, guidances (e.g., OIG program guidance), Federal Sentencing Guidelines, NPC s CIA, NPC s policies and processes
- Excellent project management skills
- Excellent interpersonal skills and ability to develop trusting relationships with stakeholders
- Excellent writing and editing skills
- Strong technical skills for online system management (e.g.. Sharepoint, html)
- Strong policy and process management skills
- Strong analytical/reasoning, problem solving, organizational and multi-tasking skills
- Demonstrated knowledge of various electronic business tools and data applications
- Demonstrated ability to work with multiple teams in an effective, efficient and professional manner
- Ability to find effective and appropriate solutions to unexpected issues/obstacles to include proactively reaching out within the organization
- Must maintain professional standards and a high level of confidentiality in the secure handling of sensitive information and material
- Must be capable of working independently and as a team player
- Must be detail-oriented
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