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Regulatory Data & Systems Senior Associate

5+ years
Not Disclosed
10 March 2, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Job Title: Regulatory Data & Systems Senior Associate

Company: Amgen

Location: Hyderabad, India

Work Type: On-Site

Employment Type: Full-Time

Job Requisition ID: R-206526

Career Category: Regulatory

Posted On: 13 Days Ago

Job Description:

The Regulatory Data & Systems Senior Associate will be responsible for interpreting and executing business requirements by leveraging industry best practices and Amgen’s regulatory processes. This role involves optimizing complex data systems supporting the health authority submission process while ensuring compliance with regulatory regulations and guidance. The ideal candidate should have expertise in system analysis and data science/AI within a regulated industry.

Roles & Responsibilities:

  • Data Administration/AI: Optimize and maintain complex data models, ensuring integration, efficiency, and regulatory compliance.
  • Regulatory Business Analysis: Interpret and implement regulatory requirements, ensuring systems and processes align with industry standards.
  • Project Coordination: Assist in planning, tracking, and executing departmental projects and initiatives.
  • Stakeholder Communication: Liaise with internal and external stakeholders to ensure timely and accurate communication regarding regulatory requirements and system updates.

Required Knowledge and Skills:

  • Strong interpersonal and teamwork skills, with the ability to collaborate with business users, technical IT groups, project managers, senior management, outsourced service providers, and vendors.
  • 5+ years of experience as a business analyst, with expertise in business analysis techniques, tools, SDLC, and agile system development methodologies.
  • Excellent oral and written communication skills, with the ability to present ideas convincingly.
  • Ability to operate effectively in a matrix environment; team player with the capability to work independently with minimal direction.
  • Familiarity with GxP requirements and systems validation.
  • Experience in the life sciences, biotech, or pharmaceutical industry.

Preferred Knowledge and Skills:

  • Advanced knowledge of Veeva Vault.
  • Familiarity with global regulatory processes and standards.
  • Proficiency in Agile methodologies, including Scrum or Kanban, for enhanced collaboration and efficiency.

Basic Education & Experience:

  • Bachelor’s degree and 2 years of directly related experience.
  • Associate’s degree and 6 years of directly related experience.
  • High school diploma/GED and 8 years of directly related experience.

Preferred Education & Experience:

  • Practical experience with regulatory data standards, such as IDMP.
  • 5+ years of experience in data management, machine learning, or related fields.