GSIM Regulatory Data Management - Associate (Amgen)

Roles and Responsibilities

Role -GSIM Regulatory Data Management - Associate

Organization -​​Global Regulatory Affairs Execution Team​

Team -Global Submission & Information Management (GSIM)

Group Purpose -Ensure the smooth compliant flow of information between all Functional areas, internal and external to GRAAS, local offices, external partners and regulatory authorities.

Job Summary

• Monitoring data quality/health, including collaboration with other internal functions to maintain planned submission and approval dates

• Integrations:

• Updating the Regulatory Submissions and Document Information Management System (RSDIMS) and Analytics:

• Metrics compilation and analysis

• Liaison with internal customers to improve efficiencies within RDA and other functional areas

• Manages requests within the Regulatory Intake System to comply with data management of a GMP system

Key Activities

• Maintain Regulatory document management and tracking systems

• Create/archive Clinical Trial and Marketing Application submissions/Health Authority correspondence

• Responsible for maintaining the on-site hard copy Regulatory archive and overseeing incoming/outgoing off-site Regulatory document storage

• Point of contact between Regulatory Representatives/CMC and publishing teams

• Manage the Protocol Amendment New Investigator (PANI) submissions and PI updates/additions

• Ensuring Regulatory compliance with SOPs and Regulatory authorities

• Provide support to RDA team members and other functional areas, including vendors

• Collaboration with external partners/outsourced CROs

• Manage 1572 forms for FDA submission

Knowledge and Skills

• Working in teams

• Minimal familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance

• Basic understanding of the Veeva Vault system

• Good written and verbal communication skills and detail oriented

• Independent time management and prioritization skills

• Ability to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy, and respect

• Critical thinking skills

• Appropriate software skills as required

Education & Experience (Basic)

Bachelor’s degree

OR

Associate’s degree & 4 years of directly related experience

OR

High school diploma / GED & 6 years of directly related experience

Education & Experience (Preferred)

• Experience in an operationally focused role within Regulatory Affairs