The Senior Associate, Data Management, will help drive key business operation initiatives within Veeva RIM Vault, ensuring alignment with global regulatory requirements such as IDMP, EU CTR, and other emerging regulations. You will lead efforts to implement and support regulatory processes, ensuring compliance, efficiency, and the delivery of high-quality regulatory information. As a subject matter expert in Veeva RIM Vault, you will collaborate with cross-functional teams to guide regulatory initiatives, ensuring the smooth adoption of new processes and system use. You will also play a key role in training and developing data standards, ensuring teams are equipped to meet the evolving demands of the regulatory landscape. Your expertise will help shape the future of regulatory operations by streamlining processes and driving compliance across global markets.
Responsibilities:
- Responsible for maintaining data within the Regulatory Information Management (RIM) system
- Create and archive clinical trial, marketing application submissions and health Authority correspondence within Amgen’s RIM system
- Serve as a Data Management SME within cross-functional collaborative initiatives
- Deliver the implementation of new processes within Veeva Vault, XeVMPD, IDMP and other key regulatory initiatives, ensuring alignment with global regulatory standards and business objectives
- Provide support on creating, running and analysing reports for data streamline projects
- Develop and deliver training materials and presentations to a global audience
- Manage the protocol Amendment New Investigator (PANI) submission updates
- Manage 1572 forms for FDA submission
- Provide support within the global data management 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.
Requirements :
- Master’s degree and 1-2 years of directly related experience OR
- Bachelor’s degree and 2-3 years of directly related experience OR
- Associate’s degree and 3-5 years of directly related experience OR
- High school diploma / GED and 5+ years of directly related experience
- Advanced knowledge of Veeva Vault RIM
- Be open to working in a dynamic environment embracing change as a constant and adopting new technologies
- Working in global teams and matrix organizations
- Able to follow through on tasks and motivate others to meet deadlines
- Practical experience with CTIS system
- Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance
- In depth understanding of the Veeva Vault system
- Good written and verbal communication skills
- Detail oriented
- Independent time management and prioritization skills
- Work efficiently with little support and minimal to no supervision
- 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
- Strong analytical and problem solving, communication and presentation skills
- Good understanding of business complexity and project inter-dependencies
- Be a great teammate who can work effectively at all levels of an organization with the ability to influence others to move toward consensus
- Fluent in English, both in oral and written communication
- Experience in supporting projects / improvement initiatives