OVERVIEW

Provides support for the activities conducted by the RA Lead, RA Labeling Lead and GLLs (Global Labelling Leads).

QUALIFICATIONS

• Bachelor Degree in Health Sciences or related field.
• 1-3 years of experience in US labeling activities: requirements, submissions, legislation, compliance. OR. 2-4 years of experience in local (own country or LATAM) labeling activities.
• Advanced English: writing and speaking.
• Be proactive, attentive to details, good command of communication, willing to learn things and be autonomous.
  IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.co

• Ensures RIM systems are up-to-date with regard to Labeling CCDS events including creation of Global Project Plan (GPP)
• Distribution of CCDS to relevant stakeholders
• Ensures update of Regulatory Information System to capture submission due dates, deferred submission dates and CCDS events that are on hold due to pending basis label approvals.
• Supports the GLL with CCDS template/content transfers, Submission Ready Quality Check (SRQC)
• Assists the Labeling Lead and Global Labeling Leads with administrative tasks.
• Manages the Takeda Global Labeling (GL) mailbox in line with GL mailbox Job Aid. For single country product emails, redirects the email to either the concerned LOC or the Labeling Lead for escalation to Labeling Oversight.
• Manages the Labeling folders on the Share Point, Share Point and Electronic Content Management (ECM).
• Operates to QMS documents and non-QMS documents for the regulatory services provided, as specified in the Training Plan.
• Enters own labeling-related tasks in the IQVIA internal Project Management tool.
• Reviews all open deliverables on a weekly basis and updates as applicable
• Updates the deliverable information and moves status to “Complete” when the deliverable is complete.