Duration: 10 Months with high possibility of extension

Qualifications:

Works closely with various stakeholders to ensure high quality of regulatory data in application. The incumbent will assess and triage global change requests as well as update or create new entities as needed. In this role, the specialist/manager will ensure timely execution of routine assignments and communicate with SMEs in various areas as necessary.

Support and execution of Data Quality initiatives, monitoring findings, contributions to execution resources and communication with other applicable regional areas.

Technical Skills

1. Superior oral and written communication skills to support customer-facing role
2. Ability to be flexible, collaborative, and work independently
3. Advanced knowledge of MS Word, Excel, and SharePoint
4. Familiarity with regulatory systems
5. Superior attentiveness to detail
6. Strong interpersonal and communication skills
7. Effective time management and organizational skills to efficiently manage multiple, time-sensitive assignments simultaneously
8. Ability to independently resolve straightforward problems that arise within job responsibilities and expectations
9. Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures

Experience:

1. Any experience using Veeva (highly preferred)
2. 3+ years experience with Registration Tracking Systems

Responsibilities:

1. Assist in managing the change control process for application's data as follows:
1. Provide support to ensure the accuracy of HRM through the monitoring, triage, and execution of ORION change requests for the US/Canada
2. Execute requests to withdrawal entities in application
3. Manage shared mailbox, respond to inquiries, and action requests
4. Provide oversight, as needed to offshore data entry personnel
5. As necessary, assist with preparation, launch and execution of HRM Data Quality initiatives
6. Maintain compliance with all required Merck training by due date
7. Supporting Regional HRM, as needed
8. As required, attend general HRM meetings as needed (HRM DQ, HRM Team, Regional HRM, FACT)

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Other

Industries

Pharmaceutical Manufacturing