Director, Global Labeling Strategy

Otsuka Pharmaceutical • Princeton, NJ • 4d ago

Drive Labeling Strategy, in-line with overall global regulatory strategy, by providing labeling expertise for Company Core Data Sheet (CCDS), USPI and local labeling from early-stage development through to product maintenance. Facilitate strategic development of labeling and labeling components, by leading a diverse cross-functional labeling subteam through discussion and decisions. Evaluate and communicate strategies and anticipate risks associated with CCDS content updates and implementation. Key role of providing labeling leadership, mentoring peers, driving strategic label development and execution of core labeling information.

Job Description

Demonstrate high-level understanding of labeling content requirements, regulations, and guidance in support of labeling strategies worldwide.
Leads or contributes to cross functional teams: Labeling Committees, Labeling Teams, and provide direction and support to Product Review Council teams, Legal and other groups, as needed.
Develop and maintain Target Product Label, Company Core Data Sheet (CCDS) and local labels.
Ensure that all labeling (for development and marketed products) is appropriately developed and maintained according to relevant laws and regulations.
High-level understanding of the dynamics and purpose of the Target Product Label and CCDS and the associated implications on labeling globally.
Evaluate and communicate risks associated with CCDS content updates and implementation strategies.
Ability to assess regional labeling to ensure compliance with CCDS.
Assess competitor labeling - understanding precedents & opportunities.
Ability to assimilate key clinical, scientific, and medical information and present it in a concise manner.
Ability to understand and address payer needs and commercial differentiation strategies.
During HA reviews, continuously assess dossier review comments for potential labeling impact, development of alternate proposals, and negotiation strategies.
Support global HA interaction strategy to discuss key labeling elements.
Lead response to Health Authority (HA) questions for labeling. Respond to labeling related inquiries from global Health Authorities in an efficient manner to meet required timelines.
Develop clear communications for senior management and SOP approvers to streamline and facilitate final label negotiations and approval.
Present to Global Labeling Review Team: Ensure Core Data Sheet accurately reflects current understanding of benefit/risk profile.
Ensure that deliverables are met, and labeling claims are consistent across programs.
Develop and implement strategies to enhance global labeling awareness – use of core data sheets, strategic global mindset.
Support all tracking, planning and storage activities related to labeling, including any computer or manual system related activities.
Follow and formulate improvements to labeling policies, processes, quality, and system tools.
Ensure policies and practices are maintained to ensure local labels are consistent with global labeling.
Analyze and interpret new regulations and Guidance, as well as monitor and determine impact on product labeling. Identify opportunities to influence regulatory policy and climate.
Provide strategic advice on implementing new regulations, as well as providing input for development of promotional messages, as needed.
Contribute to the continuous improvement of the end-to-end labeling process and support labeling inspection / audit readiness activities.
Provide leadership and mentoring to team members and motivate others to be innovative.
May be assigned additional responsibilities, as deemed necessary.

Qualifications

Required

BSc or advanced scientific degree (MSc, PhD or PharmD) preferred.
10+ years of relevant pharmaceutical Labeling/Regulatory experience.
Thorough understanding of scientific principals and regulatory systems, relevant to drug development.
Experience writing CCDS and USPI documents for new products.

Preferred

Knowledge and skills

Solid understanding of pharmaceutical regulatory affairs, global labeling regulatory requirements and industry practice.
Exceptional understanding of medical concepts and terminology.
Strong written and oral communication skills, including presentation skills.
Considerable experience in managing high to medium complex projects.
Strong 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.
Demonstrated ability to work with and manage people in a global, dynamic environment to deliver value-added results.
Proven matrix leader with excellent problem-solving innovative solutions.
Demonstrated ability to provide leadership and development for junior team members.
Solid ability to recognize and escalate issues.
The ideal candidate should be action oriented, client-driven, ability to manage workloads and set priorities and 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.

Similar Jobs

NICET Inspectors

The LiRo Group • Trenton, NJ • 1d ago

Sponsored

We have an immediate need for a NICET Inspectors for a project in Northern New Jersey. Come join our team! We are looking to build services and capabilities through the growth of our key asset- our staff. Ranked among...

1d ago

Go to Apply

Land Surveyor

The LiRo Group • Edison, NJ • 2d ago

Sponsored

We currently have a need for a Land Surveyor for New Jersey. Come join our team! We are looking to build services and capabilities through the growth of our key asset- our staff. Ranked among the nation's top A/E and C...

2d ago

Go to Apply

Systems & Technical Trainer

Canon U.S.A., Inc. • Jamesburg, NJ • 2d ago

IT & Engineering Sponsored

About our Company - Canon U.S.A., Inc., is a leading provider of consumer, business-to-business, and industrial digital imaging solutions to the United States and to Latin America and the Caribbean markets. With approxim...

2d ago

Go to Apply

NICET Inspectors

The LiRo Group • Trenton, NJ • 2d ago

Sponsored

2d ago

Go to Apply

Director, Publications Lead

Otsuka Pharmaceutical • Princeton, NJ • 2d ago

Sponsored

The Director, CNS Publications Lead is responsible for leading the planning, development, and execution of the global medical publication strategy and publication deliverables for the CNS therapeutic area. This role ensu...

2d ago

Go to Apply

Associate Director, Talent Acquisition Business Partner - Commercial

Otsuka Pharmaceutical • Princeton, NJ • 3d ago

Management & Administrative Sponsored

The Commercial Talent Acquisition Business Partner (TABP) is a strategic advisor and thought partner within the Talent Acquisition function to the Commercial business , responsible for aligning recruitment...

3d ago

Go to Apply

Call Center Supervisor

Canon U.S.A., Inc. • Burlington, NJ • 3d ago

Management & Administrative Sponsored

3d ago

Go to Apply

Associate Director, Talent Acquisition Business Partner - G&A

Otsuka Pharmaceutical • Princeton, NJ • 3d ago

Management & Administrative Sponsored

The G&A/Corporate Talent Acquisition Business Partner (TABP) is a strategic advisor and thought partner within the Talent Acquisition function to the corporate functions & affiliate client groups , r...

3d ago

Go to Apply

Director, Talent Acquisition

Otsuka Pharmaceutical • Princeton, NJ • 3d ago

Management & Administrative Sponsored

Position Overview: The Director of Talent Acquisition will lead and oversee the Talent Acquisition function which includes a team of Talent Acquisition Business Partners , T alent Acquisition O perations, an d ex...

3d ago

Go to Apply

NICET Inspectors

The LiRo Group • Trenton, NJ • 3d ago

Sponsored

We have an immediate need for a NICET Inspectors f or a project in Northern New Jersey. Come join our team! We are looking to build services and capabilities through the growth of our key asset- our staff. Ranked among t...

3d ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.