We use cookies. Find out more about it here. By continuing to browse this site you are agreeing to our use of cookies.

Job posting has expired

#alert
Back to search results

Associate Director, Labeling Operations

Avanir Pharmaceuticals, Inc
United States, New Jersey, Princeton
August 03, 2023
Leads Global Labeling Compliance oversight for all aspects of the end-to-end labeling process and systems, including distribution, tracking, metrics and reporting. Leads Global Labeling inspection / audit activities. Acts as operational expert and lead for the Global Labeling tracking in RIMs or other systems. Determines, evaluates and investigates quality events, conducts root cause analyses and develops CAPA plans, where needed. Serves as Global Regulatory Affairs contact for PSMF activities. Demonstrates understanding of labeling requirements, regulations and guidance in support of labeling strategies worldwide. Support of Labeling Operations activities, where needed.
  • Lead oversight of global distribution, tracking, and reporting of approved labeling and labeling updates.
  • Lead the monitoring and reporting of compliance metrics for end-to-end labeling processes.
  • Act as operational expert and lead for the Global Labeling tracking in RIMs or new technology / systems under evaluation
  • Lead labeling inspection / audit activities, including CAPA development and implementation.
  • Serve as Global Regulatory Affairs contact for PSMF activities.
  • Lead the tracking of all labeling changes, implementation and deviations for assigned regions.
  • Evaluate and monitor compliance metrics for end-to-end labeling process.
  • Develop and report GL metrics and dashboards to support GL compliance oversight.
  • Determine, evaluate and investigate quality events, conduct root cause analyses and develop CAPA plans.
  • Collaborate with global colleagues, affiliates and alliance partners, as needed, for effective and efficient global distribution and tracking of labeling updates for products.
  • Collaborate for development, review and maintenance of labeling agreements with alliance partners and company subsidiaries.
  • Ensure labeling is in accordance with all current regional regulatory regulation, guidance and requirements.
  • Ensure content reviews and QC checks are performed for consistency between internal labeling documents (i.e., Core Data Sheet and other core labeling documents) and all local/regional labeling and supportive documents.
  • Manage and maintain labeling documents in document management systems; Manage label review and approval.
  • Contribute to the continuous improvement of the end-to-end labeling policies, processes, quality, and system tools.
  • Ensure development and maintenance of templates, collaboration features and system upgrades.
  • Act as GL subject matter expert when a new labeling technology and/or system is being evaluated.
  • Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate.
  • Support of Labeling Operations activities, where needed.
  • Responsibilities may include the managing of direct/indirect reports to assist with compliance tracking.
  • May be assigned additional responsibilities, as deemed necessary.

Knowledge and skills

  • Solid understanding and interpretation of US labeling regulatory requirements, preferred.
  • Solid understanding of pharmaceutical regulatory affairs and willingness to learn global labeling regulatory requirements and industry practice.
  • Solid understanding of requirements for tracking of labeling updates
  • Solid understanding of the structure of product labeling
  • Strong written and oral communication and organizational skills
  • Strong attention to detail
  • Solid aptitude for use of IT systems; preferable knowledge with Regulatory Information Management System (RIMS) and electronic document management system (EDMS); Proficiency in MS Office suite; Willing to learn additional applications
  • Ability to generate problem solving innovative solutions
  • Ability to recognize and escalate issues
  • The ideal candidate should be action oriented, customer focused, ability to manage workloads and set priorities. In addition, he/she should be capable of dealing with ambiguity, be creative, be comfortable working with multifunctional teams.

Qualifications

  • MS/BS in life sciences or another scientific field.
  • 6-8 years of relevant experience in pharmaceutical regulatory/labeling environment and/or drug development
  • Global Labeling tracking experience (concepts & systems)
  • Electronic document management systems use and / or electronic submission experience.

#MZ1 #LI-remote #labeling

Come discover more about Otsuka and our benefit offerings; .

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 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 .

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 .

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: , or your local authorities.

(web-86bf545f88-sggxd)