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Associate Director Data Ops & Analytics, Rdq

7+ years
Not Disclosed
10 Oct. 30, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Summary

As the Research & Development Quality (RDQ) representative, you will support key business processes related to Database Development, Data Management, Statistical Programming, and Analytics. Your expertise will ensure that clinical data flow, management, and analysis processes meet Novartis standards, Health Authority regulations, and GCP guidelines. You will engage with R&D business and quality teams to identify potential quality risks and provide guidance on control and mitigation measures.

About the Role

Key Responsibilities:

  • Provide quality advice and oversight to ensure compliance with required standards and regulations throughout data flow and analysis processes.
  • Support relevant business functions during audits and inspections, including CAPA creation.
  • Partner with various divisions to implement digital capabilities and new technologies in drug development and clinical trial processes.
  • Act as an ambassador for Novartis values and behaviors.
  • Collaborate across functions to develop effective business strategies for Database Development, Data Management, Statistical Programming, and Analytics.
  • Ensure quality documents are fit for purpose and compliant with Novartis standards and regulations.
  • Assess new processes and technologies for quality risks.
  • Identify regulatory and compliance risks and help establish mitigation mechanisms.
  • Provide guidance in investigations, root cause analysis, and quality incident assessments.
  • Contribute to cross-functional projects aimed at improving Novartis standards and processes.
  • Foster a culture of collaboration and capability building through educational initiatives and training.

Essential Requirements:

  • Over 10 years of relevant experience in the pharmaceutical industry or public health sector, focusing on Quality, Information Technology, Data & Digital, or Clinical Development.
  • Strong background in GCP, PV, and Health Authority regulations, with an understanding of CSV and privacy regulations.
  • Exemplary interpersonal skills reflecting Novartis values of collaboration, quality, and integrity.
  • Flexibility in problem-solving and innovative thinking.
  • High learning agility and comfort with complexity and diversity.
  • Excellent communication skills across various organizational levels.
  • Proven ability to build effective relationships with internal and external partners.
  • Change management skills to sustain a culture of compliance and high ethical standards.

Desirable Requirements:

  • Bachelor’s degree in Life Sciences, Statistics, Information Technology, or related fields; a Master’s degree is a plus.

Why Novartis?

Our purpose is to reimagine medicine to improve and extend people’s lives. Our vision is to become the most valued and trusted medicines company in the world. We believe that our people drive our ambitions every day. Join us in this mission!

Benefits and Rewards:

Learn more about our benefits and rewards in the Novartis Life Handbook: Benefits & Rewards

Join Our Network:

If this role isn’t the right fit for you but you wish to stay connected with Novartis, join our talent community: Novartis Network

Accessibility and Accommodation:

Novartis is committed to providing reasonable accommodations to individuals with disabilities. For assistance during the recruitment process, please contact us at diversityandincl.india@novartis.com, including the job requisition number.

Commitment to Diversity:

Novartis is dedicated to building an inclusive work environment with diverse teams that reflect the communities we serve.