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PROOFREADER / LABELING
100% Remote Role!
Pay Ranges from $24.50 – $28.74 an hour!
Position is 20-40 hours per week – Average hours per week would be 30.
Required Skills:
- 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 Microsoft Office Suite.
- Good understanding of pharmaceutical or medical terminology.
- Experience in proofreading, including prescription drug labeling.
- Familiarity with labeling-related regulations and industry practice a plus.
- Prior experience with electronic proofreading tools a plus.
- Spanish, or other international market proofreading capabilities will be an advantage.
Project Description:
- 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 affected supplements.
- Proofread prescription drug labeling, packaging, and submission documents for US & International markets -primarily in English.
- Review documents for accuracy, clarity, and consistency of content and format; correct spelling, grammar, and punctuation.
- 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.
This 6+ month position starts ASAP.
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE