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Associate Director, Clinical Transparency Reporting & Systems Managmnt

Company: Novartis AG
Location: East Hanover
Posted on: May 16, 2022

Job Description:

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
Purpose:
The clinical transparency reporting and systems management lead is responsible for all clinical transparency data transfer/capture and system management/configuration between source systems and the Novartis aggregate spend solution. This individual will also be responsible for the successful review, validation, correction, and submission of clinical transparency data into the CMS portal. This role requires a high level of technical competencies with extensive knowledge of relational database management and data analysis ensuring systems are correctly producing required output and potential data errors are identified early and remediated in a timely manner
Major Accountabilities


  • Collaboration with CMS, industry groups, and external experts ensuring new and existing federal clinical transparency reporting requirements are in alignment with Novartis policy and identify / lead implementation of process improvements in collaboration with legal and ERC.
  • Responsible for communicating Novartis policy and technical requirements (functional / system specifications and data transfer requirements) to internal partners and external stakeholders ensuring Novartis policies / technical requirements are understood and deliverables are in alignment with Novartis expectations.
  • Technical management of the Novartis Aggregate Spend Solution back-end business rules and data mappings ensuring systems are producing the correct output to meet federal clinical transparency reporting obligations.
  • Responsible for the ongoing evaluation of system specifications ensuring both front-end interface and back-end relational databases are meeting Novartis expectations and successfully capturing, aggregating, and allocating payments and transfers of value to meet government reporting requirements.
  • As system or data-related issues are identified, generate root cause analysis, and ensure technical teams (both Novartis Aggregate Spend and Source Systems) understand root cause and lead corrective action plan from technical enhancements through implementation and testing.
  • Proactively perform advanced analytics through the development/generation of relational database queries identifying clinical data issues originating by source systems or within the Novartis Aggregate Spend Solution (i.e., record duplication, transactional outlier analysis, incomplete records, errors with mapping or business rules, etc.).
  • Proactively perform advanced analytics through the development/generation of relational database queries identifying clinical data issues within the CMS submission file prior to sending files to the federal government (i.e., validation of covered recipients, duplication submission records, aggregate outlier analysis, etc.)
  • Lead the successful review, validation, and correction of clinical transparency data and responsible for the submission of clinical transparency data into the CMS portal ensuring data is complete and accurate.
  • Manage 2-4 direct reports ensuring the successful collaboration between Novartis and third-party Clinical Research Organizations (CROs) overseeing communications, developing / establishing processes, driving alignment on policy and technical requirements, and implementing technical quality checks.
  • Support ad-hoc clinical reporting requests from legal, ERC and other internal functions through the development/generation of relational database queries (i.e., CRO utilization, Clinical Trail payments and transfers of values, and other metrics).
  • Oversee dispute management process for all clinical transparency data inquires ensuring the appropriate resolution is provided in a timely manner.
  • Establish business partner relationships with internal (e.g., cross-functional teams, affiliate organizations, global teams, etc.) and external stakeholders influencing peers and gaining alignment on policy and processes across the organization

    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
    Education:

    • Bachelor's Degree (or equivalent 4-Year University degree) required
    • Computer Science Degree (or equivalent) desired

      Experience:

      • 7+ years of Pharmaceutical Industry experience preferred
      • Experience/familiarity with regulatory Pharma guidelines (Sunshine Act, EFPIA, OIG, etc.)
      • Extensive experience in Systems Management, Relational Database Management, and Advanced Analytics.
      • In-depth knowledge of Relational Databases and ability to develop/generate complex queries (utilizing tools such as SQL, MS Access, etc.)
      • Experience with Aggregate Spend Reporting and associated processes, technologies, and systems.
      • Familiarity with Clinical Trails and associated payments and transfers of value (ToV) for Sunshine Reporting (i.e., Study Drug, Equipment, etc.)
      • Excellent data interpretation, analysis, and system processing skills
      • Demonstrated track records of success in contributing to the business, including enhancing business models and performance
      • Ability to establish business partner relationships with internal stakeholders and skilled at influencing peers across the organization
      • Strong communication skills, which includes verbal, presentation, and written communication skills. Ability to communicate across all levels of the organization.
      • Ability to manage complex projects and multiple projects simultaneously

        Preferred Requirements

        • Experience with, and responsibility for, clinical transparency and other aggregate spend initiatives in a pharmaceutical, biotech or medical device manufacturer
        • In-depth knowledge of relational databases and ability to develop/generate complex queries (utilizing tools such as SQL, MS Access, etc.)
        • Strategic problem-solving skills
        • Previous experience manages teams

          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 at Novartis!
          Commitment to Diversity & Inclusion:
          Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.
          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:
          Accessibility and reasonable accommodation
          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.

          Division
          PHARMA
          Business Unit
          US PHARMA
          Location
          USA
          Site
          East Hanover, NJ
          Company / Legal Entity
          Novartis Pharmaceuticals
          Functional Area
          Legal & Intellectual Property & Compl.
          Job Type
          Full Time
          Employment Type
          Regular
          Shift Work
          No

Keywords: Novartis AG, New York , Associate Director, Clinical Transparency Reporting & Systems Managmnt, Executive , East Hanover, New York

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