Director, Global Labeling
Otsuka Pharmaceutical

Princeton, New Jersey

Posted in Pharmaceuticals


This job has expired.

Job Info


Position Summary

  • Leads preparation, review, and update of content for the development and maintenance of labeling and labeling components.
  • Provides leadership, people management and tactical input on the planning and execution of labeling initiatives
  • Formulates improvements to labeling policies, processes, quality, and system tools.
  • Lead continuous improvement efforts of the end-to-end labeling process
  • Develop and implement strategies to enhance global labeling awareness and tracking
  • Demonstrate a high-level understanding of labeling content requirements, regulations and guidance in support of labeling strategies.
  • Support inspection readiness activities related to all global labeling components
  • May be assigned additional responsibilities as deemed necessary.
  • Develop and maintain Target Product Profile, Company Core Data Sheet (CCDS) and local labels (US, EU, Canada)
  • Evaluate and communicate risks associated with CCDS content updates and implementation strategies
  • Understand and address key scientific, clinical, medical and payer needs, including commercial differentiation strategies
  • Assess competitor labeling - understand precedents & opportunities for Health Authority (HA) discussions
  • Support global HA interaction strategy to discuss key labeling elements
  • During HA reviews, continuously assess dossier review comments for potential labeling impact, development of alternate proposals, and negotiation strategies
  • Develop clear communications for senior management and SOP approvers to streamline and facilitate final label negotiations and approval


Key job responsibility
  • Ensures all labeling components (for new and existing product labels and labeling) are appropriately developed and maintained according to relevant laws and regulations - including the response to labeling request changes in an efficient manner to meet required timelines.
  • Leads or contributes to cross functional teams: Labeling Committees, Labeling Teams, and provides direction and support and leadership to Product Review Council teams, Legal and other groups as needed.
  • Present to Labeling Oversight Committee: Ensure Core Data Sheet accurately reflects current understanding of benefit/risk profile.
  • Follows and formulates improvements to labeling policies, processes, quality, and system tools.
  • Ensure policies and practices are maintained so that local labels are consistent with global labeling.
  • Contribute, develop & implement solutions to build awareness and global strategic mindset
  • Support all tracking, planning and storage activities related to labeling including any computer or manual system related activities
  • Support inspection readiness activities related to all global labeling components
  • Analyses 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.

Knowledge, Skills, and Competencies
  • Solid understanding of global labeling regulatory requirements and industry practice
  • Solid understanding of medical concepts and terminology
  • Strong written and oral communication skills
  • Excellent computer skills including experience with Regulatory Information Management System (RIMS), EDMS, XML including SPL systems and MS Office: Word, Excel, PowerPoint, SharePoint and Outlook
    • Ability to generate problem solving innovative solutions and motivate others to be innovative
    • Ability to recognize and escalate issues
    • Managing and Measuring Work
    • Presentation Skills
    • Interpersonal and Negotiation Skills

The ideal candidate should be action oriented, customer focused, able to manage workloads, set priorities, and have demonstrated the ability to build effective teams. In addition, he/she should be capable of dealing with ambiguity, be creative, be comfortable working with multifunctional teams and show strong business acumen.

Physical Demands and Work Environment

Travel (approximately 10%)

Education and Related Experience
  • PhD/MS/DVM/MD/BS in life sciences, scientific, or engineering field.
  • 10+ years of relevant experience in pharmaceutical regulatory/labeling environment.
  • Experience writing CCDS and USPI documents for new products.
  • Demonstrated ability to work with and manage people in a global, dynamic environment to deliver value-added results.


#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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