Senior Manager GRAAS Operations

Amgen Inc.

3.6

(9)

Hyderabad, India

Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging
  • #R-202074

    Position summary

    ndscapes and technology trends.

    • System Process Simplification: Find opportunities to simplify and streamline system-based processes and user interfaces

    • Team Leadership: Lead a team of experts responsible for the implementation, maintenance, and continuous improvement of regulatory information systems and data management processes.

    • Vendor Management: Collaborate with external vendors and technology partners to optimize system capabilities and influence product roadmaps to meet organizational needs.

    • Data Model Expertise: Serve as a data model expert with a focus on IDMP, ensuring that the organization's regulatory information aligns with evolving data standards and requirements

    • Enterprise User Base Support: Provide guidance, training, and support to a large user base, ensuring successful utilization of regulatory information systems.

    • Compliance Assurance: Ensure that all regulatory information systems and adhere to relevant regulatory requirements, standards, and data security protocols.

    What we expect of you
    We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

    Basic Qualifications:
    • Doctorate degree and 2 years of regulatory systems experience OR
    • Master's degree and 8 to 10 years of regulatory systems experience OR
    • Bachelor's degree and 10 to 14 years of regulatory systems experience OR
    • Diploma and 14 to 18 years of regulatory systems experience

    Preferred Qualifications:

    • Leadership: Implement the strategic roadmap for regulatory information systems, aligning technology initiatives with organizational goals and regulatory compliance requirements.

    • Subject Matter Expertise: Serve as an in-house domain expert (SME) on regulatory information management, keeping abreast of evolving regulatory landscapes and technology trends.

    • System Process Simplification: Find opportunities to simplify and streamline system-based processes and user interfaces

    • Team Leadership: Lead a team of experts responsible for the implementation, maintenance, and continuous improvement of regulatory information systems and data management processes.

    • Vendor Management: Collaborate with external vendors and technology partners to optimize system capabilities and influence product roadmaps to meet organizational needs.

    • Data Model Expertise: Serve as a data model expert with a focus on IDMP, ensuring that the organization's regulatory information aligns with evolving data standards and requirements

    • Enterprise User Base Support: Provide guidance, training, and support to a large user base, ensuring successful utilization of regulatory information systems.

    • Compliance Assurance: Ensure that all regulatory information systems and adhere to relevant regulatory requirements, standards, and data security protocols.

    Preferred Knowledge and Skills:

    • Advanced knowledge of Enterprise Information management systems such ERP, QMS, & Change Management,

    • Familiarity with global regulatory requirements and standards beyond the organization's primary market.

    • Proficiency in Agile methodologies, including Scrum or Kanban, to enhance collaboration, efficiency, and adaptability within an Agile work environment.

    • Experience with regulatory documents in Regulatory Affairs, Research, Development, Quality Management, or related area

    • Experience in implementing large scale enterprise systems in the Biotech/Pharmaceutical industry

    What you can expect of us
    As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
    In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
    Apply now
    for a career that defies imagination
    Objects in your future are closer than they appear. Join us.
    careers.amgen.com

    .

    Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging