Posted in Other 25 days ago.
This job brought to you by Local Organization
Type: Full Time
Location: Princeton, New Jersey
Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.
In pharmaceuticals, Otsuka is a leader in the challenging area of maental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.
Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016.
All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.
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.
Leads preparation, review, and update of content for the development and maintenance of labeling and labeling components. The ideal candidate will be results-oriented with concerns for quality and collaboration. They will demonstrate a high-level understanding of labeling content requirements, regulations and guidance in support of labeling strategies. 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
• Understand implications for promotional and HTAs from local labeling
• 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
• Lead labeling cross-functional project sub-teams and facilitate cross-functional leadership team committee meetings
• Participate in global regulatory affairs & safety governance sub-teams
• Coordinates the internal labeling approval process as specified by standard operating procedure.
• Complete finalization and formatting of USPI, SmPC and Product Monographs
• Manage labeling negotiations during registrational review
• Develop and maintain Core Data Sheet in electronic data management system (EDMS)
• Support local regulatory offices to develop country specific labeling that is consistent with the Core Data Sheet
• Manage post-approval changes and country-specific updates
• Manage SOP reviews and approvals
• Support all tracking, planning and storage activities related to labeling including any computer or manual system related activities
• Leads inspection readiness activities related to all global labeling components.
• Follows 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
• Present to Labeling Oversight Committee: Ensure Core Data Sheet accurately reflects current understanding of benefit/risk profile
• Provides training to employees on regulations for labeling compliance as appropriate
• Reports into Director, Global Labeling and preferably based in Princeton, New Jersey office.