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Sr. Associate - Strategic Planning & Operations

3+ years
Not Disclosed
10 Nov. 19, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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

Senior Associate – Strategic Planning & Operations

Location: India, Hyderabad
Work Type: On-Site
Job ID: R-228339
Date Posted: November 3, 2025
Category: Clinical Development

Overview

Amgen’s Center for Observational Research (CfOR) is a global leader in Real-World Evidence (RWE) generation, supporting drug development, regulatory submissions, and commercialization strategies across the full product lifecycle. With increasing demand from regulatory and reimbursement authorities, observational research is a critical component of modern clinical development.

The Senior Associate, Strategic Planning & Operations, will support CfOR’s operational programs, non-interventional studies, and enterprise-wide initiatives. This role requires strong project management capability, operational excellence, and comfort with emerging AI tools to streamline processes and enhance productivity.

Key Responsibilities

  • Provide operational and specialized support to Observational Research Scientists managing global RWE studies.

  • Deliver comprehensive documentation and study support across multiple regions and therapeutic areas.

  • Drive adoption of productivity platforms such as Smartsheet, AI tools, Microsoft Teams, and Miro to enhance collaboration and project tracking.

  • Support strategic initiatives, including operational pilots and change-management programs, to strengthen CfOR capabilities.

  • Ensure quality and accuracy of assigned deliverables, contributing to overall departmental performance.

  • Communicate project status, operational risks, and updates across CfOR and with cross-functional partners.

  • Assist in study start-up and study close-out activities, ensuring compliance with internal processes.

  • Identify opportunities for process automation, operational efficiency, and workflow consistency.

  • Develop, maintain, and evaluate process flow diagrams to support high-quality operational execution.

  • Track, reconcile, and report study milestones and deliverables using internal systems.

  • Conduct regular meetings with study leads to monitor operational progress and address issues.

  • Identify and support cross-functional process improvement initiatives.

  • Manage financial transactions, including purchase order creation, invoice verification, payment processing, and engagement with finance partners using systems such as Anaplan, Ariba, or SAP.

Basic Qualifications

  • Bachelor’s degree with 6+ years of scientific or operations experience, or

  • Master’s degree with 4+ years of scientific or operations experience.

Preferred Qualifications and Skills

  • Minimum 3 years of project management experience, including 2+ years in pharma/biotech or regulated clinical environments.

  • Experience in budgeting, vendor management, and regulated document management systems.

  • Strong organizational skills with the ability to manage multiple priorities independently.

  • Demonstrated analytical skills and adaptability to new technologies, concepts, and workflows.

  • Effective communication skills across written, verbal, and presentation formats.

  • Ability to build collaborative relationships with a proactive and solutions-oriented approach.

  • Proficiency with modern productivity and collaboration platforms, including ChatGPT, Copilot, Smartsheet, Miro, SharePoint, Microsoft Teams, and Office 365.

  • Familiarity with drug commercialization processes and business operations.

  • Working knowledge of Good Clinical Practice (GCP), FDA regulations, and key compliance frameworks relevant to clinical and commercial operations.

How to Apply

Interested candidates may submit their applications through the official portal.