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Position Summary
• The specialist is 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.
• Will represent the assigned countries or region as a Subject Mater Expert as needed in meetings regards change impact assessment, status or implementation for project teams, and if needed during strategy assessments affecting their core product or region.
• Supporting the Labeling Operations team with Labeling Document Creation.
• Supports US/EU/ILO teams as per the business need.
Duties/Responsibilities
• Quality review of CCDS and country specific labeling documents (as prescription drug labeling, packaging and submission documents) for US, EU & International markets
• Review of documents for accuracy, clarity, and consistency of content and format; correct spelling, grammar, and punctuation
• Coordinate and collaborate with internal and external stakeholders to ensure delivery timelines are met
• Highlight (for additional review) other non-grammatical inconsistencies observed such as with artwork or layout when proofreading materials
• Perform administrative tasks in support of Labeling Operations team, e.g. maintaining files and documentation, updating spreadsheets, coordinating workflows.
• Supports US/EU/ILO teams as per the business need.
• Proactively identifies risks and issues, and develops solutions to challenging areas related to assigned projects / countries in the interest of keeping projects streamlined and moving forward.
• May work directly with external and global project teams (e.g. Local Regulatory, Global labeling Strategy, International Strategy leads, Artwork Team, Supply Chain and manufacturing operations sites) as required to support the country, region and/or products assigned.
• Maintains up-to-date knowledge and understanding of regulatory labeling requirements of assigned region or countries.
• Support creation of labeling documents, such as Composition copy, SPL draft word document and annotated document, annual reports, in support of the Labeling teams.
• May work under the guidance of the Regional Labeling Operations Lead and serves as a back-up for the Regional Labeling Operations Lead.
• 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.
• Supporting the Labeling Operations team with Labeling Document Creation.
Qualifications Specific Knowledge, Skills, Abilities:
• 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
• Good organizational skills, project management skills and a meticulous eye for details
• 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
Education/Experience/ Licenses/Certifications:
• Bachelor’s degree (Science or English) preferred
• A minimum of 2 years of experience in a regulated environment, including use of a range of electronic tools.
• Experience formatting and editing labelling documents in MS Word and Adobe Acrobat. Ability to troubleshoot complex document issues
• Experience in including prescription drug labeling is a plus.
• Experience working on multi-disciplinary teams and projects
• Prior experience with electronic proofreading tools a plus
• Direct BMS experience may be considered instead of Labeling experience/ college degree/ managerial experience.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
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R1604793 : Specialist, Global Labeling