Director Ethics, Risk and Compliance R&D

Employer
Novartis
Location
Hyderabad, India
Salary
Competitive
Closing date
Feb 6, 2023

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Sector
Pharmaceutical, Regulatory Affairs
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Professional
Job Description

Millions! Novartis made a decision to pursue early discovery research internally to allow us to quickly translate the most impactful discoveries into therapeutics for millions of patients.

Be a trusted business partner that inspires associates to be curious and embrace principle-based thinking to help deliver innovative ethical, risk and compliant solutions. Serve as an advocate that understands the changing compliance landscape and specific ethical chal-lenges related to NIBR/Research and GDD/Development (R&D) in India and serve as an enterprise connector. Identify proactive strategies/solutions to address business needs and potential risks, and help ensure that activities and processes comply with all applicable poli-cies, laws, regulations, practices and codes.

Major Accountabilities :
• Competent Advisory Services: Provide sound leadership and business decision advisory support to the India R&D organizations as an independent Ethics, Risk and Compli-ance (ERC) associate. Enable the achievement of business goals, objectives, and innovative new approaches in a manner that complies with company policy, laws and regulations, relevant guidance, codes requirements. In addition, drive simplification of the pro-cesses and procedures. Advise local R&D leadership team regarding ethical challenges, compliance obligations, risks & resilience and actual or potential ERC related issues.
• Strategic Vision Alignment: Support the Global and India ERC Programs and related culture of integrity, in collaboration with the strategic partners within R&D India and ERC. Perpetuate a “tone at the top” and “middle” with India R&D leadership team that reflects R&D’s commitment to ethical business conduct.
• Risk Assessment, Monitoring, and Remediation Plans: Leverage structured risk framework and facilitate an integrated risk management approach that enhances the ability to detect risks early and to mitigate, monitor and remediate the risks. Provide guidance and input into R&D’s Risk Assessment Plan, related self-monitoring plans, aggregated risks and any other relevant remediation plans.
• Monitoring and Investigations Oversight: Complete relevant training in response to monitoring or inquiries assigned by the Speak Up Office related to India R&D organizations according to monitoring and investigation protocols. Identify and oversee inquiries for review and coach the business on proper ethical or compliant conduct.
• Compliance Reporting, Data Analytics, and Root Cause Analysis: Proactively ad-dress organization trends by liaising with India R&D associates to help ensure aware-ness and mitigation planning related to the results of any dashboard/KPI metrics and re-porting pertaining to the effectiveness of the compliance program as it relates to India R&D's specific activities and results.
• Compliance Projects: Support the implementation and execution of new compliance-related policies, practices or projects including the new Code of Ethics, professional practices policy, Conflict of Interest policy, etc.
• Culture: Promote and facilitate a continuous learning environment via the identification and communication of actual or suspected gaps or failure to adhere to Novartis policy, laws and regulations by R&D associates in accordance with relevant Code of Ethics re-porting obligations.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

• Bachelor's Degree or equivalent 4 Year University Degree required. Advanced degree e.g., Masters in Juris Prudence, JD, or other high-level education relevant to the practice of law and/or healthcare compliance expertise preferred. Completion of relevant certification program preferred (e.g., Seton Hall Healthcare Compliance Certification, ECI LPEC Certification, CCEP, CHC).
• 10+ years’ experience in the pharmaceutical industry. In depth understanding of the operations of a pharmaceutical company including manufacturing, marketing, sales, and distribution.
• Strong knowledge of relevant regulatory/compliance re-quirements (e.g., Federal HealthCare Program and FDA laws, regulations, cGCP, codes, guidance (e.g., OIG pro-gram guidance), Federal Sentencing Guidelines, NPC CIA
• Excellent interpersonal skills and ability to develop trusting relationships with stakeholders. Strong partnering skills to identify and leverage knowledge from across the organization.
• Strong track record of partnering with business to establish a common vision to enhancing business performance. Strong analytical/reasoning, problem solving, organizational and multi-tasking skills
• Strong policy, process and project management skills
• Excellent presentation skills, including ability to prepare and deliver analytical, written and oral communications appropriate-ate for multiple audiences and levels within the organization
• Demonstrated ability to establish strong external networks accessed and relationships built with experts in the field, industry peers and regulatory authorities to remain current on compliance and other industry related trends
• Experience developing content and delivering quality education programs
• 10-30% travel required

Why consider Novartis?

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

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