Apr 19, 2022

Job Description

9 out of 10 prescriptions here in the US are filled by generic drugs. Sandoz is one of the top developers and manufacturers of life changing generic medicines and Sandoz has the aspiration to be the Leading Generic and Biosimilar Company in the world with a purpose of pioneering access for patients. We are looking for curious, innovative, driven people to help us get new generic and biosimilar products into the market to improve access for patients. Maybe that’s you.

The Associate Director, CIA Auditing and Monitoring position will primarily lead, conduct and coordinate activities needed to fulfil the auditing and monitoring related obligations in the Sandoz Corporate Integrity Agreement (CIA). For example, position will conduct annual audits associated with the Sandoz Risk Assessment and Mitigation Process (RAMP) and conduct monitoring activities associated with the Internal Monitoring Program. The position will be responsible for developing effective auditing/monitoring plans designed to assess adherence to Federal health care program requirements, company policies and procedures and CIA obligations. The role will also support various activities associated with the Sandoz ERC investigations, risk management, auditing, monitoring and the Independent Review Organization (IRO.)

Primary Responsibilities:
• Develops and leads internal audits required as part of the Sandoz CIA RAMP obligations.
• Support the Sandoz risk identification and prioritization processes, including annual CIA RAMP questionnaires and support US Sandoz functional risk assessment workshops and activities. Partner with key stakeholders to ensure alignment across ERC and the organization.
• Effectively communicate audit and monitoring observations and develop remediation plan with key stakeholders and executive management.
• Supports tracking the implementation of the corrective action plans to assess effectiveness of CIA RAMP activities.
• Conducts Contract Monitoring and Records Reviews required as part of CIA Internal Monitoring and Review Efforts obligations.
• Support Independent Review Organization (IRO) activities, including managing regular status update meetings, organizing document requests, and tracking observations / remediation efforts.
• Support Sandoz local matter investigation processes as required, including conducting investigations of local matters as assigned by the Executive Director, CIA Lead.
• Establish credible and collaborative business relationships across the organization with functional areas.
• Ensure adherence to and maintenance of established work programs and processes, timely and effective implementation of any new deliverables based on the outcome of audit and monitoring.
• Prepare reports, generate insights, create/track metrics and as required present findings / observations to leadership related to relevant risk, audit and monitoring activities.
• Provide support to other ERC risk, auditing monitoring activities (e.g., functional risk assessments and P3 related monitoring).

Diversity & Inclusion / EEO

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 other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

What you will bring to this role:
• Bachelor’s Degree or equivalent 4-Year University degree. Advanced degree preferred.
• 5-7 years industry pharmaceutical experience
• Preferred combination in jobs relating to analytical finance, auditing, consulting, IT, compliance/law and/or pharmaceutical project management experience
• Very strong written and verbal communication skills
• Strong understanding of key elements of pharmaceutical compliance program (e.g., CIA, policy, monitoring, risk assessment, reporting, etc.)
• Strong partnering skills and ability create productive working relationships with stakeholders

Why 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!

Commitment to Diversity & Inclusion:

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

Accessibility and Reasonable Accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected].

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
Princeton, NJ
Legal & Intellectual Property & Compl.
Full Time
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Associate Director, CIA Auditing and Monitoring

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