HERE'S THE JOB DESCRIPTION:
Title: Regulatory Affairs Senior Associate #13034 (2 openings)
Pay Rate: up to $39/hr
Location: Remote-Based
Length: 1 year contract possible extension

*This will be a 100% remote role. Looking for a candidate who is able to work standard hours (ex. 7a-4p or 8am-5p etc.), with EST timezone preferred. The candidate would need to have flexibility to shift their hours to start and end their day at a later time, if additional support is needed for the PST timezone.

Top Must Have Skill Sets:

• Good communication skills (verbal & written)
• Resourceful critical thinker
• Experience in process mapping and detail/data quality focused
• Regulatory Affairs understanding highly preferred**
• Any regulatory certifications (RAC) is desirable
• Interest in technical aspects of systems i.e. SQLs etc. will also be considered

Job Summary:
Sr. Associate - Records Information Management & Systems (RIMS)
In order to support our team's ongoing projects, we are seeking a candidate who is comfortable with learning new systems, has experience managing content in SharePoint, has working experience with the Six Sigma methodology, process mapping and project management experience.
Responsibilities:

• Support the implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives.
• Work with stakeholders to gather requirements and develop solutions.
• Provide Subject Matter Expertise in Veeva Vault Configuration and Regulatory Processes to a global user base.
• Develop and deliver training materials and presentations to a global audience.
• Author/review/approve quality Regulatory Information Management & Systems documents
• Analysis of the existing documentation and process explore avenues to simplify and streamline.
• Provide operational support for Regulatory Data Management, Submissions, and EU CTR.
• Develop and implement process improvements and automation.
• Lead and/or support team projects.
• Organize and present data in user-friendly, graphical, interactive informational summaries that illustrate how GRAAS is performing and allow us to understand and improve business
  performance
• Utilize the Six Sigma method to support team processes.

Basic Qualifications:

• Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
• Works well collaboratively.
• Detail oriented
• Comfortable learning new systems/processes.