HireMO

Remote

Full time

R13189

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 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

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.

Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

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.

Come discover more about Otsuka and our benefit offerings; https://ah-prod.com/multi/videoplayer/player.html?v=6385356920112 .

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Senior Manager, Global Labelling Operations

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