Regulatory Affairs Senior Associate - REMOTE

HERE'S THE JOB DESCRIPTION:
Title: Regulatory Affairs Senior Associate #12671
Pay Rate: up to $38/hr
Location: Remote-Based
Length: 1 year contract + possible extension

Job Summary:
Sr. Associate - Records Information Management & Systems (RIMS)

As the Global Labeling Lead product lead for marketed products, leads product-specific global labeling development and maintenance activities throughout a product's life cycle.

Top Must Have Skills:

• Comfortable with learning new systems
• Experience managing content in SharePoint
• Working experience with the Six Sigma method
• 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.

Qualifications:

• Science/Technology-based degrees are preferred OR industry-specific experience. If the candidate has experience in performing the team’s tasks and would be able to do this job, the type of degree would not necessarily matter.
• Experience with managing content in SharePoint
• Working experience with the Six Sigma method
• Project Management experience
• Works well collaboratively, as there is a lot of teamwork involved in what we do.
• Detail oriented, to be able to monitor data quality.
• Comfortable learning new systems/processes. Someone who is able to follow instructions/guides, since we work in a framework based on rules/compliance.
• Good communication skills (verbal & written), resourceful critical thinker, detailed
• Once training is completed, this individual must then understand how to utilize the tools provided to complete needed tasks, which requires resourcefulness and critical thinking skills.