Sr Associate Digital Governance

1 day ago

Hyderabad, Telangana, India Amgen Inc Full time ₹ 9,00,000 - ₹ 12,00,000 per year

ABOUT THE ROLE

The Digital Governance team supports the Global Regulatory Affairs and Strategy organization in the constant pursuit of Execution Excellence. They do this by managing the tracking and documentation of Amgens global digital sites and projects for compliance purposes.

The Sr. Associate Digital Governance will support the Digital Governance Business Process Owner (DSR BPO) in maintaining the accuracy of Amgens global digital site database. They are responsible for ensuring database records are kept up to date, responding to inquiries for database reports, following up on pending actions, and assisting users with process-related questions. This role will be on a flex shift to allow for live training and collaboration.

Roles & Responsibilities:

  • Support tracking and documentation of Amgens global digital sites and projects for compliance purposes
  • Promote compliance for Amgens digital and social media asset inventory
  • Provide guidance to inquiries regarding Amgens global digital database
  • Assign training as needed to Amgen employees who manage or support digital assets
  • Update formal process documents (SOPs, guidance/training documents) as needed
  • Quality check digital assets against database information to ensure accuracy
  • Follow up on overdue database task assignments
  • Work with Domain Law to register Amgen URLs
  • Support Digital Governance management in identifying areas of risk and concern
  • Execute and document effectiveness checks
  • Support corrective actions and regulatory inspections
  • Maintain weekly and quarterly database reports
  • Test digital site contact information to ensure compliance
  • Provide Project Management support to key initiatives
  • Maintain project management standards and methodology
  • Provide change management support to key initiatives

Required Knowledge and Skills:

  • Deep knowledge of Veeva PromoMats database management processes
  • Excellent written/oral communication skills and attention to detail
  • Strong problem-solving skills and the ability to navigate complex situations
  • Adaptability to assist in meeting urgent goals in a complex environment
  • Familiarity with pharmaceutical regulatory compliance requirements (US and global)
  • Experience with social media and website management
  • Knowledge of Excel
  • Ability to work collaboratively in a team environment
  • Project Management
  • Change Management

Preferred Knowledge and Skills:

  • Understanding of pharmaceutical regulatory compliance requirements in a global database environment
  • Awareness of social media requirements and processes

Basic Education and Experience:

Masters degree

OR

Bachelors degree and 3 years of related experience

OR

Associates degree and 5 years of related experience

Preferred Education and Experience:

  • Masters or bachelors degree
  • Experience working in a Global Regulatory Affairs or Pharmacovigilance organization

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