Associate Director Graas Operations

14-20 years

Not Disclosed

Hyderabad

10 Dec. 3, 2024

Job Description

Job Type: Full Time Education: PhD/BSc/MSc/DPharma/PharmD/MBBS/BDS/BAMS/BHMS/MD 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

Let’s Do This. Let’s Change the World.

In this vital role, you will lead operational excellence, innovation, and technical compliance for Amgen's global regulatory submission and information management. By driving smooth, compliant data flows and fostering collaboration among internal teams, external partners, and regulatory authorities, you will design and implement improvements in processes, technologies, data standards, and organizational change management.

As a Global Submission and Information Management Associate Director, you will shape and execute the strategic framework for regulatory submissions and systems. Your leadership will harmonize global submission portfolios with regulatory system strategies, ensuring compliance, operational excellence, and a forward-thinking approach to innovation.

Key Responsibilities

Leadership & Strategy

Manage and mentor a high-performing AIN team responsible for submissions, data management, and regulatory systems.
Develop resourcing strategies leveraging internal teams and external partners for submission-related activities.
Shape and execute strategies to align submission systems with evolving business and regulatory needs.

Operational Excellence

Drive process improvements in submission tools, workflows, and methodologies.
Maintain and optimize data models, including IDMP, SPL, and other regulatory standards.
Ensure compliance with global and regional regulatory requirements and data security standards.

Collaboration & Vendor Management

Oversee vendor collaborations to enhance system capabilities and influence product roadmaps.
Build strong relationships with internal teams and regulatory authorities to align on submission and data strategies.

Innovation & Compliance

Champion innovative technologies and process enhancements to drive efficiency and industry leadership.
Monitor and adapt to trends in regulatory landscapes, integrating them into system updates and process improvements.

What We Expect of You

We value diverse perspectives and contributions in our mission to serve patients. The professional we seek is a dynamic leader with the following qualifications:

Basic Qualifications:

Doctorate degree and 3+ years of experience in regulatory submissions or systems OR
Master’s degree and 10–14 years of experience OR
Bachelor’s degree and 14–16 years of experience OR
Diploma and 18–20 years of experience.

Preferred Knowledge and Skills:

Proven leadership in regulatory submissions and information management.
Advanced knowledge of global and regional regulatory requirements, including eCTD and related software.
Expertise in regulatory information management systems (RIMS) and data models (IDMP, SPL).
Strong program/project management skills, with experience managing cross-functional teams.
Analytical problem-solving skills to address complex regulatory and system challenges.
Experience with large-scale enterprise systems in the Biotech/Pharmaceutical industry.
Comprehensive understanding of regulatory operations, submission management, and data standards.

What You Can Expect from Us

At Amgen, we are committed to your professional and personal growth. Our comprehensive benefits and inclusive, collaborative culture support you every step of the way.

Competitive base salary with Total Rewards Plans aligned to industry standards.
A dynamic environment that fosters innovation, collaboration, and excellence.

Apply Today
Transform the lives of patients while redefining your career. Visit careers.amgen.com to apply.

Amgen is an Equal Opportunity Employer
We are committed to fostering diversity and inclusivity and providing reasonable accommodations for individuals with disabilities during the hiring process and beyond. Contact us for assistance as needed.

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Associate Director Graas Operations

Job Description

Key Responsibilities

What We Expect of You

Basic Qualifications:

Preferred Knowledge and Skills:

What You Can Expect from Us

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