4931 George Road Tampa, FL 33634 US
Target Pay Rate: 20-28.74/hr **salary will be commensurate with experience
Candidate is responsible for proofreading labeling documents including US package inserts and CPLP/CCDSs. Additionally, he/she is responsible for data entry, data tracking and assisting with document distribution globally. Can also be responsible for proofreading labeling documents including US package inserts and components, and harmonized Spanish and English inserts and components for Export markets. He/she is responsible for performing labeling operational activities for assigned projects associated with annual reports, prior approval supplements and changes being effected supplements.
- Proofread prescription drug labeling, packaging and submission documents for US & International markets -primarily in English. Spanish, or other international market proofreading capabilities will be an advantage.
- Review documents for accuracy, clarity, and consistency of content and format; correct spelling, grammar, and punctuation
- Electronic proofreading software experience, a plus.
- Highlight (for additional review) other non-grammatical inconsistencies observed such as with artwork or layout when proofreading materials
- Coordinate and collaborate with internal stakeholders to ensure delivery timelines are met
- Create supporting US labeling documents: Composition copy, SPL, core template; coordinate with other Coordinators and Labeling Specialists to meet delivery standards and deadlines
- Verify language sources from SmPC and USPI for international markets; mark up inconsistencies and escalate to Labeling Specialist for review and remediation
- Ensure recent major USPI changes are applied, verifying hyperlinks in annotated documents and ensure accuracy of cross references in labeling
- Bachelor's degree (Science or English) preferred`
- A minimum of 1 year of labeling proofreading experience in a regulated environment, or at least 3 years other specialized proofreading or pharmaceutical experience
- Excellent command of English grammar, spelling and punctuation.
- Prior experience proofreading, preferably in a regulated environment, including use of a range of tools
- Demonstrated capabilities in meticulous work practices, attention to detail and working in a team environment
- Proficiency in standard office technology, including the Microsoft Office Suite
- Good understanding of pharmaceutical or medical terminology
Ideal Candidates Would Also Have:
- Familiarity with labeling-related regulations and industry practice a plus
- Experience in proofreading, including prescription drug labeling
- Prior experience with electronic proofreading tools a plus
**CO/NY candidates may not be considered
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