Job Description

Career Category Regulatory

ABOUT AMGEN
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
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 Amgen's 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 Amgen's 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 Amgen's global digital sites and projects for compliance purposes
• Promote compliance for Amgen's digital and social media asset inventory
• Provide guidance to inquiries regarding Amgen's 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:
Master's degree
OR
Bachelor's degree and 3 years of related experience
OR
Associate's degree and 5 years of related experience
Preferred Education and Experience:

• Master's or bachelor's degree
• Experience working in a Global Regulatory Affairs or Pharmacovigilance organization

AIN working hours for this position:
This position supports the Regulatory Promotion and Material Compliance activities serving Amgen's US Business Operations and thus the AIN working hours will need to be flexible with occasional overnight work time when needed to support product launches and new indications.
EQUAL OPPORTUNITY STATEMENT
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
.