Sr US labelling lead - Ampcus Incorporated
chicago, IL
About the Job
The Senior US Regulatory Labeling Lead is responsible for conducting independent and comprehensive reviews of US PI labeling documents to ensure regulatory compliant labeling. Before US Label and Approval (US LAT) review and following
FDA approval of final US product labeling, this position partners with RA (or RegCMC) managers and performs final quality checks, confirming that all FDA-approved labeling changes are accurately incorporated into internal master U.S. product labeling documents prior to their being forwarded for use by other groups within e.g.: product packaging and US promotional materials/activities."
Responsibilities
• "Performs US Labeling quality review of US PI in accordance with relevant company policies and procedures.
• Provide recommended changes along with justifications to RA Managers for their product labeling documents based on FDA Guidance, AMA Manual of Style Guide and ISMP’s List of Error-Prone Abbreviations, Symbols, and Dose Designations.
• Provide additional up-front review (before US Labeling Approval Team review) to address potential areas of concern rather that correcting approved prescribing information.
• Support PLLR implementation initiatives according to the PLLR Implementation plan and collaborate with RA Managers on USPI conversions Support proofreading activities of text for labeling of pharmaceutical products as required by FDA (21 CFR 201); ensures SPL/PLLR compliance within package insert; identifies inconsistencies and errors as needed.
• Provides guidance/support to RA/GL Managers and liaises with other BUs/BFs or Hyderabad US Labeling Team to ensure achievement of business objectives/timelines.
• Following FDA approval of final US product labeling, partners with RA (or Reg-CMC) managers and performs final quality checks, confirming that all FDA-approved labeling changes are accurately incorporated into internal master U.S. product labeling documents prior to their being forwarded for use by other groups within e.g.: product packaging and US promotional materials/activities."
Experience
• "8+ years of experience in RA, QA, pharmaceutical product labeling or equivalent experience. Effective planning, organizational, and interpersonal skills.
• Computer skills (i.e., MS Office, etc.). Strong written and verbal skills. Ability to work with and/or lead project teams; multi-task.
• Knowledge/experience of U S regulations, guidelines. "
FDA approval of final US product labeling, this position partners with RA (or RegCMC) managers and performs final quality checks, confirming that all FDA-approved labeling changes are accurately incorporated into internal master U.S. product labeling documents prior to their being forwarded for use by other groups within e.g.: product packaging and US promotional materials/activities."
Responsibilities
• "Performs US Labeling quality review of US PI in accordance with relevant company policies and procedures.
• Provide recommended changes along with justifications to RA Managers for their product labeling documents based on FDA Guidance, AMA Manual of Style Guide and ISMP’s List of Error-Prone Abbreviations, Symbols, and Dose Designations.
• Provide additional up-front review (before US Labeling Approval Team review) to address potential areas of concern rather that correcting approved prescribing information.
• Support PLLR implementation initiatives according to the PLLR Implementation plan and collaborate with RA Managers on USPI conversions Support proofreading activities of text for labeling of pharmaceutical products as required by FDA (21 CFR 201); ensures SPL/PLLR compliance within package insert; identifies inconsistencies and errors as needed.
• Provides guidance/support to RA/GL Managers and liaises with other BUs/BFs or Hyderabad US Labeling Team to ensure achievement of business objectives/timelines.
• Following FDA approval of final US product labeling, partners with RA (or Reg-CMC) managers and performs final quality checks, confirming that all FDA-approved labeling changes are accurately incorporated into internal master U.S. product labeling documents prior to their being forwarded for use by other groups within e.g.: product packaging and US promotional materials/activities."
Experience
• "8+ years of experience in RA, QA, pharmaceutical product labeling or equivalent experience. Effective planning, organizational, and interpersonal skills.
• Computer skills (i.e., MS Office, etc.). Strong written and verbal skills. Ability to work with and/or lead project teams; multi-task.
• Knowledge/experience of U S regulations, guidelines. "
Source : Ampcus Incorporated