Senior Manager Global Labeling
Otsuka Pharmaceutical

Princeton, New Jersey

This job has expired.


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
  • Ensures that all labeling components are appropriately maintained according to relevant laws and regulations.
  • 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
  • Tracks all labeling changes and implementation for assigned regions
  • 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


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 escalate 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


#MZ1

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

Disclaimer:

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

Valid Proof of COVID-19 Vaccination or Accommodation

The COVID-19 Vaccination is mandatory for incoming new hires and employees. Uploading documentation with proof of full vaccination record or an Otsuka approved accommodation will be required during the pre-employment process as permitted by law. New hires must be fully vaccinated unless there is an approved accommodation prior to start date.

Statement Regarding Job Recruiting Fraud Scams

At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.

Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.

Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.

To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.

Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities.


This job has expired.

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