Sr Manager Global Labeling at Otsuka Pharmaceuticals
Posted in Science 16 days ago.
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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 mental 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.
With limited supervision, prepares, reviews, and updates content that is required for the development and maintenance of labeling and labeling components. Ensures that all labeling and components meet regulatory and company requirements. The ideal candidate will be results-oriented with concerns for quality and collaboration. They will show initiative and want to continue to develop and acquire new expertise. May be assigned additional responsibilities as deemed necessary.
- Provides operational support including but not limited to quality checks, document submissions and inspection readiness.
- Tracks global labeling implementation and provides operational support to fulfill and meet local heath authority requests and deadlines.
- Analyses and interprets new regulations and guidances as well as monitors and determines the impact of the regulatory environment and applicable regulatory decisions affecting labeling.
- Drafts labeling materials to ensure that the information conveyed is consistent with the applicable data for the product.
- Provides input into the product development and regulatory strategies and translate into appropriate labeling language throughout the lifecycle of the product.
- Follows and recommends improvements to labeling policies, processes, quality, and system tools.
- Provides training to employees on regulations for labeling compliance and system tools.
- Provides creative and innovative ideas to move the Global Labeling and Regulatory department to address current and future challenges.
- Reports into Director, Global Labeling and preferably based in the Princeton, New Jersey office.
- Bachelor's degree in life sciences, scientific, or engineering field.
- 3+ years of relevant experience.
- Understanding of global labeling regulatory requirements
- Broad knowledge of clinical, CMC, preclinical and clinical pharmacology
- Understanding of medical concepts and terminology
- Understanding of the structure and function of the product labeling
- Fundamental understanding of the pharmaceutical industry drug development process
- Able to work across multifunctional teams
- Strong written and oral communication skills
- Can deal with ambiguity
- Good computer skills including experience with XML including SPL systems, MS Office: Word, Excel, PowerPoint, and Outlook and Adobe products
- Action oriented, customer focused, ability to manage workloads and set priorities.
Ability to generate problem solving innovative solutions