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Senior Manager Graas Operations

14-18 years
Not Disclosed
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 a team, provide subject matter expertise, and collaborate with key stakeholders to drive innovation and efficiency within regulatory affairs. The Senior Manager will champion continuous improvement in enterprise regulatory systems, streamline data models, and influence vendor partnerships to ensure compliance while achieving measurable business outcomes.


Key Responsibilities

Leadership and Strategy

  • Implement the strategic roadmap for regulatory information systems, aligning technology initiatives with organizational goals and compliance standards.
  • Lead a team of experts responsible for implementing, maintaining, and improving regulatory information systems and data management processes.

Subject Matter Expertise

  • Act as an in-house domain expert (SME) on regulatory information management, staying informed about evolving regulatory landscapes and emerging technologies.
  • Provide expertise in data models, focusing on IDMP to ensure alignment with industry standards.

System Process Optimization

  • Identify opportunities to simplify and enhance system-based processes and user interfaces.
  • Collaborate with external vendors and technology partners to optimize system functionality and influence product development roadmaps.

Team and Stakeholder Engagement

  • Train, support, and guide a large enterprise user base to maximize the successful utilization of regulatory information systems.
  • Foster collaboration across teams to enhance system usability and regulatory compliance.

Compliance Assurance

  • Ensure all regulatory information systems adhere to global regulatory requirements, data security protocols, and organizational standards.

What We Expect of You

We value diversity and unique contributions in serving patients. The professional we seek is a strategic leader and innovative thinker with these qualifications:

Basic Qualifications:

  • Doctorate degree and 2+ years of regulatory systems experience OR
  • Master’s degree and 8–10 years of regulatory systems experience OR
  • Bachelor’s degree and 10–14 years of regulatory systems experience OR
  • Diploma and 14–18 years of regulatory systems experience.

Preferred Qualifications:

  • Advanced knowledge of enterprise information management systems, including ERP, QMS, and Change Management.
  • Familiarity with global regulatory requirements and standards beyond primary markets.
  • Expertise in Agile methodologies (Scrum or Kanban) to drive efficiency and adaptability.
  • Experience working with regulatory documents in Regulatory Affairs, Research, Development, or Quality Management.
  • Proven track record of implementing large-scale enterprise systems in the Biotech/Pharmaceutical industry.
  • Strong project management skills, with a focus on cross-functional collaboration and stakeholder engagement.

What You Can Expect from Us

At Amgen, we are committed to helping you grow both professionally and personally. With competitive benefits, a supportive culture, and a commitment to innovation, we provide the resources you need to succeed.

  • Competitive base salary and Total Rewards Plans aligned with local industry standards.
  • Opportunities for career development within a collaborative and innovative environment.

Apply Today
Take the next step toward a career that defies imagination. Join us at careers.amgen.com.


Amgen is an Equal Opportunity Employer
We welcome all qualified applicants and are committed to providing reasonable accommodations for individuals with disabilities during the application or interview process, as well as during employment. Please contact us to request accommodations.