Associate Data Management

Amgen Inc

5 - 10 years

2 - 5 Lacs

Hyderabad

Posted:2 months ago| Platform:

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Skills Required

data management data analysis information management veeva vault kubernetes project management sfdc business analysis knowledge management autocad sql docker ansible apex salesforce salesforce crm autodesk inventor java git linux jenkins aws

Work Mode

Work from Office

Job Type

Full Time

Job Description

As an Associate, Regulatory Data Management you will help ensure the compliance of our regulatory data via the smooth compliant flow of information across our systems and processes. Roles & Responsibilities: Provide support on maintaining our Regulatory Information Management (RIM) system. Create and archive clinical trial, marketing application submissions and health Authority correspondence within the organisation RIM system. Serve as a point of contact between regulatory representatives, CMC, safety, partners and the submission management team. Provide support on creating, running and analysing reports for data streamline projects. Provide support within data management global team on US Certificate of Pharmaceutical Product (CPP) and EU Certificate of Medicinal Product (CMP) during additional workload periods. Adhere to Amgen processes, policies, guidelines, SOPs and training documentations. Required Knowledge and Skills: Highly motivated, organised, and detailed oriented team player. Familiarity with regulatory procedures and filings. Familiarity with global clinical and regulatory health authorities’ requirements e.g. FDA, EMA, MHRA etc. Preferred Knowledge and Skills: Working knowledge of the Veeva Vault platform is preferred Basic Education and Experience: Master’s degree and some directly related experience OR Bachelor’s degree and 2 years of directly related experience OR Associate’s degree and 4 years of directly related experience OR High school diploma / GED and 5+ years of directly related experience Preferred Education and Experience: Practical experience with regulatory data standards, such as IDMP