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Manager, Labeling Strategy

Company: Otsuka Pharmaceutical
Location: Stamford
Posted on: November 25, 2022

Job Description:

Job SummaryDemonstrates understanding of labeling content requirements, regulations and guidance in support of labeling strategies worldwide reporting to the Director of Labeling Strategy Regulatory Affairs. Develops labeling and labeling components - including preparation, review, and content update in collaboration with the labeling sub team for review and approval by Otsuka Senior Management. Maintains Company Core Data Sheet (CCDS) and local/regional labels (US, EU, Canada). Evaluates and communicates strategies and anticipates risks associated with CCDS content updates and implementation. Assesses competitor labeling - understands precedents & opportunities. Leads response to Health Authority (HA) questions for labeling. Contributes to the continuous improvement of the end-to-end labeling process and supports labeling inspection / audit readiness activities.Job Description

  • Ensures that all labeling (for development and marketed products) is appropriately developed and maintained according to relevant laws and regulations.
  • Responds to labeling questions in an efficient manner to meet required timelines.
  • Supports all tracking, planning and storage activities related to labeling including any computer or manual system related activities
  • Follows and formulates improvements to labeling policies, processes, quality, and system tools.
  • Ensure policies and practices are maintained to ensure local labels are consistent with global labeling
  • Contributes to cross functional teams: Labeling Committees, Labeling Teams, and provides direction and support to Product Review Council teams, Legal and other groups as needed.
  • Analyzes and interprets new regulations and Guidances as well as monitors and determines their impact on product labeling.
  • Provides strategic advice on implementing new regulations as well as provides input for development of promotional messages as needed.
    QualificationsRequired
    • PhD/MS/DVM/MD/BS in life sciences, scientific, or engineering field.
    • 3-4 years of relevant experience in pharmaceutical regulatory/labeling environment.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 AccommodationThe 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 ScamsAt 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.

Keywords: Otsuka Pharmaceutical, Stamford , Manager, Labeling Strategy, Executive , Stamford, Connecticut

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