This is a 100% Remote
Position is 20-40 hours per week. Average hours per week would be 30. Hours are based on work volume.
- 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