Senior Manager, Global Labelling Operations

Otsuka Pharmaceutical Companies (U.S.); United States; On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401(k) match

Paid holidays

Paid leave

Job summary

Otsuka Pharmaceutical Companies (U.S.) is seeking a labeling professional to support development and lifecycle management of CCDS and local labeling, working with the Global Labeling Lead and regulatory teams. This role collaborates with worldwide Otsuka colleagues, alliance partners, and cross-functional teams to ensure compliant, publication-ready labeling and timely submissions.

The ideal candidate will have strong proofreading/editing skills, experience with regulatory documentation, and the

Qualifications

• Bachelor’s Degree plus at least 5–6 years of labeling experience in drug development.
• Experience with electronic document management systems and electronic submissions.

Responsibilities

• Maintain labeling components according to laws and regulations.
• Ensure labeling formatting and quality requirements met; monitor impact on labeling.
• Suggest improvements to labeling policies, processes, and tools.
• Track labeling changes for assigned regions; monitor compliance metrics.
• Review labeling processes and act as SMEs when new labeling tech is evaluated.

Skills

US labeling regulations

Attention to detail

Communication skills

Problem solving

Document management systems

Proofreading

Education

Bachelor’s Degree in life sciences or related field

Tools

Documentum

RIMS

XML-based QA

Job description

• Support of RA Global Labeling Lead (GLL)/Labeling Strategist during the development and life-cycle management of the Company Core Data Sheet (CCDS) and Local Labeling, as needed.
• Partner with RA Global Labeling Lead GLL/Labeling Strategist in development, update and maintenance of package labeling (artwork).
• Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate.
• Collaborate with global Otsuka colleagues, Otsuka affiliates and Alliance partners, as needed.
• Create competitor labeling and precedent documents to support development of labeling.
• Ensure labeling is in accordance with all current regional regulatory regulation, guidance and requirements. Content reviews and QC checks are performed to ensure consistency between internal labeling documents (i.e.., Core Data Sheet and other core labeling documents) and all local/regional labeling and supportive documents, including artwork.
• Support creation, compliance, update and submission of SPL, including drug listing and establishment registration activities. Ensure that FDA postings (DailyMed, NDC Directory, Establishment Directory, etc) remain current.
• Manage and maintain labeling documents in document management systems; Manage label review and approval
• Partner with Regulatory Managers to ensure that all labeling is submission ready and available for publishing
• Partner with Technical Operations and Supply Chain for preparation of labels and labeling into artwork for submission and/or implementation into packaging.
• Author, contribute, and/or review labeling sections of various periodic reports (i.e., Annual Report, PSUR, PADER, etc)
• Contribute to the continuous improvement of the end-to-end labeling process including excellent proofreading / editing skills and compiling supportive documentation
• Support and maintain Global Labeling Compliance activities and initiatives, including metrics, tracking and documentation
• Support labeling inspection/audit readiness activities
• May be assigned additional responsibilities, as deemed necessary

Position Summary

• Support of RA Global Labeling Lead (GLL)/Labeling Strategist during the development and life-cycle management of the Company Core Data Sheet (CCDS) and Local Labeling, as needed.
• Partner with RA Global Labeling Lead GLL/Labeling Strategist in development, update and maintenance of package labeling (artwork).
• Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate.
• Collaborate with global Otsuka colleagues, Otsuka affiliates and Alliance partners, as needed.
• Create competitor labeling and precedent documents to support development of labeling.
• Ensure labeling is in accordance with all current regional regulatory regulation, guidance and requirements. Content reviews and QC checks are performed to ensure consistency between internal labeling documents (i.e.., Core Data Sheet and other core labeling documents) and all local/regional labeling and supportive documents, including artwork.
• Support creation, compliance, update and submission of SPL, including drug listing and establishment registration activities. Ensure that FDA postings (DailyMed, NDC Directory, Establishment Directory, etc) remain current.
• Manage and maintain labeling documents in document management systems; Manage label review and approval
• Partner with Regulatory Managers to ensure that all labeling is submission ready and available for publishing
• Partner with Technical Operations and Supply Chain for preparation of labels and labeling into artwork for submission and/or implementation into packaging.
• Author, contribute, and/or review labeling sections of various periodic reports (i.e., Annual Report, PSUR, PADER, etc)
• Contribute to the continuous improvement of the end-to-end labeling process including excellent proofreading / editing skills and compiling supportive documentation
• Support and maintain Global Labeling Compliance activities and initiatives, including metrics, tracking and documentation
• Support labeling inspection/audit readiness activities
• May be assigned additional responsibilities, as deemed necessary

Key Job Responsibilities

Key job responsibility Percentage of time spent on performing it The importance rank *

• Ensures that all labeling components are appropriately maintained according to relevant laws and regulations. 35 1
• Ensures compliance with new formatting and quality requirements and monitors and determines their impact on product labeling
• Proactively suggests improvements to labeling policies, processes, quality, and system tools 15 2
• Tracks all labeling changes and implementation for assigned regions 35 1
• Review and monitor compliance metrics for end to end labeling process
• Acts as labeling operations subject matter expert when a new labeling technology and/or system is being evaluated 15 2

2=Very important

1=Critical

Knowledge, Skills, And Competencies

• Highly motivated and results-oriented individual, with concerns for quality and collaboration. Should demonstrate initiative and the drive to continue to develop and acquire new expertise
  • Solid understanding and interpretation of US labeling regulations, guidance and precedent
  • Solid understanding of requirements for tracking of labeling updates
  • Solid understanding of the structure of the product labeling
  • Solid understanding of the pharmaceutical industry drug development process
  • Attention to detail
  • Possess problem-solving and decision making skills with the ability to recognize and escale issues
  • Excellent written and oral communication and organizational skills
  • Problem Solving
  • Prior experience with document management systems and/or electronics submissions is required.
  • An aptitude for the use of IT systems; preferable that they have knowledge of Documentum/electronic document management, Regulatory Information Management Systems (RIMS), XML-based and comparative text quality control systems. Proficiency in standard office technology, including Microsoft Word/Suite, Outlook Mail/Calendar and willing to learn additional applications as needed
  • Proofreading of labeling documents
  • Assist Global Labeling Lead/Labeling Strategist with other tasks, as needed

The ideal candidate should be action oriented, customer focused, can manage workloads, and set priorities. In addition, he/she should be capable of dealing with ambiguity and be comfortable working with multifunctional teams.

Education And Related Experience

Required:

• Bachelor’s Degree plus at least 5-6 (Manager) years of experience in labeling for drug development
• Candidates having electronic document management systems use and or electronic submission experience

Competencies

Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.

Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.

Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.

Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.

Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.

Empowered Development - Play an active role in professional development as a business imperative.

Application Deadline

This will be posted for a minimum of 5 business days.

Company benefits

Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting [e-mail].

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.