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Associate Director, Global Labeling

Remote: 
Full Remote
Contract: 
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Offer summary

Qualifications:

MS/BS in life sciences or related scientific field., 6-8 years of experience in pharmaceutical regulatory or labeling environment., Knowledge of scientific principles and regulatory systems relevant to drug development., Experience in writing CCDS and local labeling documents for new products..

Key responsabilities:

  • Act as Global Labeling Strategy Lead for assigned compounds.
  • Lead cross-functional labeling teams to align content and strategy.
  • Evaluate risks associated with CCDS content updates and implementation strategies.
  • Manage labeling documents and support global health authority interactions regarding labeling.

Otsuka Pharmaceutical Companies (U.S.) logo
Otsuka Pharmaceutical Companies (U.S.) Pharmaceuticals Large https://www.otsuka-us.com/
1001 - 5000 Employees
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Job description

Job Summary

Responsible for working with cross-functional teams across the organization to drive and align the development and maintenance of global labeling (e.g. CCDS, regional product labels, and patient labeling) for assigned compounds. Makes recommendations and provides labeling advice and feedback for labeling content, processes, and timelines to ensure compliance with labeling regulations and guidance. Delivers high-quality submission labeling and artwork for complex drug products, specific therapeutic/disease areas, and cross functional teams. Actively contributes to continuous improvement of end-to-end labeling processes and systems.

Job Description

  • Act as Global Labeling Strategy Lead, supporting preparation, review, and update of content for the development and maintenance of Company Core Data Sheet (CCDS), local labeling and labeling components.
  • Lead the cross-functional labeling team for assigned compounds to drive alignment of labeling content and strategy.
  • Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the product global strategy and key messaging.
  • Evaluate and communicate risks associated with CCDS content updates and implementation strategies.
  • Drive labeling for package labeling (artwork) development, update, and maintenance through collaboration with a cross-functional team.
  • Support global HA interaction strategy regarding all aspects of labeling, including submissions, responses to questions, and negotiations.
  • Demonstrate understanding of current labeling content requirements, regulations, and guidance to ensure all assigned compound labeling documents are accurate, consistent, and compliant.
  • Assess competitor labeling in the same therapeutic class, competitor labeling and labeling trends, proposing content as relevant to support optimized labeling
  • Support creation, compliance, update, and submission of SPL, including drug listing and establishment registration activities. Ensure that FDA postings are current and accurate (DailyMed, NDC Directory, Establishment Directory, etc).
  • Manage and maintain labeling documents in document management systems; Manage label review and approval.
  • Author, contribute, and/or review labeling sections of various periodic reports (i.e., Annual Report, PSUR, PADER, etc.).
  • Support inspection readiness activities related to all global labeling components.
  • 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.
  • Develop clear communications for senior management and labeling stakeholders, to streamline and facilitate label development, negotiations, and approval.
  • Review and propose continuous improvements to Global Labeling policies, end-to-end processes, quality, and system tools.
  • May be assigned additional responsibilities, as deemed necessary.

Qualifications

Required

  • MS/BS in life sciences or other scientific field.
  • 6-8 years of relevant experience in pharmaceutical regulatory/labeling environment and/or drug development
  • Knowledge of scientific principals and regulatory systems, relevant to drug development
  • Experience writing CCDS and local labeling documents for new products.

Preferred

Knowledge and skills

  • Solid understanding and practical knowledge of labeling regulatory requirements, regulations and guidance required
  • Solid understanding of implications of global labeling across the organization and globally
  • Solid understanding of the structure of product labeling
  • Experience in effectively/appropriately prioritizing and managing multiple high to medium complex projects simultaneously
  • Ability to work independently or in teams, globally. Ability to lead broad range of stakeholders at all levels internally and externally to the company.
  • Effective 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 think strategically, communicate risks, and recommend 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.

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 $164,530.00 - Maximum $245,985.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.

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://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 employerAll 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 disabilityYou can request reasonable accommodations by contacting Accommodation Request. 

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Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities.  All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property.  No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Required profile

Experience

Industry :
Pharmaceuticals
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Communication
  • Microsoft Office
  • Detail Oriented
  • Strategic Thinking
  • Problem Solving
  • Social Skills
  • Time Management
  • Teamwork

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