Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation.
Post : Pharmaceutical Labeling Operation Coordinator
Job Description
Position Summary
Responsible for proofreading labeling-related documents to support the Labeling Operations teams, including but not limited to the CCDS (Company Core Data Sheet) and US, EU, and International labeling and artwork documents.
Key Responsibilities
• Proofread CCDS and country specific labeling documents (as prescription drug labeling, packaging and submission documents) for US, EU & International markets
• 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 and external stakeholders to ensure delivery timelines are met
• Perform administrative tasks in support of Labeling Operations team, e.g. maintaining files and documentation, updating spreadsheets, coordinating workflows.
• Support creation of labeling documents, such as composition copy and SPLs, in support of the Labeling teams.
• Verify language sources from SmPC and USPI for international markets; mark up inconsistencies and escalate to Labeling operation team for review and remediation
• Maintain proofreading tracker; enter real-time data on status of proofreading activities
• Ensure recent major reference document changes are applied, verify hyperlinks in annotated documents and ensure accuracy of cross references in labeling
• Participate and work in team environment, working and communicating on multiple projects and tasks effectively and in a timely manner
• Supports the end-to-end process to minimize the risk and associated costs of a significant error occurring in the final labeling preparation that results in a product recall due to labeling.
Candidate Profile
• Bachelor’s degree (Science or English) preferred
• A minimum of 2 years of proofreading experience in a regulated environment, including use of a range of electronic tools. Labeling proofreading experience is a plus
• Excellent command of English grammar, spelling and punctuation.
• Demonstrated capabilities in meticulous work practices, attention to detail and working in a team environment
• Good understanding of pharmaceutical or medical terminology
• Proficiency in standard office technology, including Microsoft Suite, Outlook Mail/Calendar; willing to learn additional applications as needed
• Spanish, or other international market proofreading capabilities a plus
• Good organizational skills and a meticulous eye for details
• Experience in proofreading, including prescription drug labeling
• Proven ability to verify developed label content against source documents relying upon proofreading skills and electronic tools to include TVT and Global Vision.
• Good understanding of pharmaceutical or medical terminology
• The ability to work as part of a team that supports global functions with a high level of professionalism in the pharmaceutical and scientific documentation discipline
• Familiarity with labeling-related regulations and industry practice a plus
• Prior experience with electronic proofreading tools a plus
Additional Information
Qualification : Bachelor’s degree (Science or English) preferred
Location : Hyderabad
Industry Type : Pharma / Healthcare/ Clinical research
End Date : 10th August, 2023
See All Ph.D Alerts M.Pharm Alerts B.Pharm Alerts MBA Alerts
See All Other Jobs in our Database
.png)
