Senior Coordinator Pharmaceutical Labeling Operations

Year    Hyderabad, Telangana, India

Job Description


Working with Us
Challenging. Meaningful. Life-changing. Those aren\xe2\x80\x99t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You\xe2\x80\x99ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: .

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.

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.

Supporting the Labeling Operations team with Labeling Document Creation.

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, SPL draft word document and annotated document, annual reports, 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.
  • Supporting the Labeling Operations team with Labeling Document Creation.
Qualifications & Experience
  • Bachelor\xe2\x80\x99s 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
  • Labeling document preparation 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, project management 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
#HYDDD #LI-Hybrid

If you come across a role that intrigues you but doesn\xe2\x80\x99t 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 \xe2\x80\x9cTransforming patients\xe2\x80\x99 lives through science\xe2\x84\xa2 \xe2\x80\x9d, 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 an inclusive culture, promoting diversity 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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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 . Visit to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Bristol-Myers Squibb

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Job Detail

  • Job Id
    JD3132010
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Hyderabad, Telangana, India
  • Education
    Not mentioned
  • Experience
    Year