The Manager Regulatory Operations coordinates high quality and on time regulatory publishing deliverables in line with the strategic direction of their assigned programs/products, identifies impact of agency guidance updates relevant to submission process, and drives innovative process change for improved efficiency. Job Description As an integral member of Otsuka's regul

Main financial partner for senior management team. Collaborate with Shared Services Finance team from affiliate organization. Help complete comprehensive forecasting and trend analysis. Monitor performance indicators and highlight trends for senior management. Investigate material financial discrepancies in collaboration with Shared Services Finance Team. Support the annu

With a keen eye for detail, help administer the Learning Management System Use eLearning software to revise training content as needed (e.g., ability to edit PDFs, Articulate Storyline, RISE courses, video editing, etc.) Apply graphic design principles to refine and simplify PowerPoint slides to enhance message clarity Design learning surveys, organize and interpret data,

Responsible for management of Clinical Supply Operations (CSO) group. Responsible for managing the strategic and technical aspects of clinical packaging and global supply chain support at contract packaging vendors. Responsible for technical assessments and selection of contract packaging vendors to provide service for specific projects. Reviews and approves contracts for

Otsuka is a leader and innovator in the CNS therapeutic area, with a strong portfolio of development and marketed assets. The Medical Director GMA is a key leader within medical affairs and serves as the medical lead for high priority CNS programs. Working under the leadership of the Sr Director CNS, they will develop and execute strategic medical plans for assigned produ

At Otsuka our mission is to create new products for better health worldwide. Our purpose is to defy limitation so that others can too. In this exciting role, as a Manager within the OAPI supply chain team, you will look to acheive operational goals while working cross functionally across various departments to support development, planning, and implementation of the S&OP

As a Sr. Process Technician you will primarily be responsible for executing work orders in the manufacturing clean rooms to realize output ingestible sensor product. In addition to equipment/process operation you will be required to perform technical production activities, equipment adjustments, equipment troubleshooting and repair on our automated semi conductor, pick an

The Executive Director Translational Medicine will be responsible for design, execution and reporting of First in Human (FIH), Translational Medicine (TM) and Proof of Concept (POC) studies and will work closely with Discovery, Preclinical, Biomarker, Genomics, Bioanalytical and Global Clinical Development teams to ensure efficient and scientific execution of early phase

The Senior Medical Writer is a writing based position within our Global Regulatory Affairs department. He/she will ensure communications are complete, well organized and scientifically accurate, and that messaging is consistent throughout all technical documentation. He/she will manage processes intended to increase project efficiency, quality, and the timely achievement

Provide CMC regulatory expertise for investigational and marketed products to project teams. Establish CMC regulatory strategies for investigational and marketed products. Ensure Otsuka's products are developed/maintained in compliance with global regulatory requirements and guidances primarily US and secondarily EU for smooth, timely approvals or continued marketing. Pos

Own the creation, documentation, and management of the end to end employee lifecycle processes including new hire processing, on boarding and integration, employee relations, exits, and maintenance of employee records Identify and action opportunities for automation, manager and employee self service Continuously improve the quality of HR data and processes to ensure mean

Explore and analyze common pharmaceuticals data (e.g., claims), identifying patterns that can inform decision making and creating visualizations to help communicate findings. Build, test, and deploy production grade predictive models and algorithms as part of the Omnichannel COE decision engine to meet business needs, including optimization of sales activities and predict

The Director, IT Business Partner Channel Strategy, Patient Support, and Market Access Technology engages and partners with Commercial business leaders to understand business priorities and needs, and then translate them into technology solutions. The Business Partner core responsibilities include Business Relationship Management Business Process and Technology Strategy P

Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy "Otsuka people creating new products for better health worldwide." Otsuka is seeking an Associate Director/Director/Senior Director, Global Clinical Development (remote) responsible for the design and oversight of clinical research programs and protocols for OPDC products under good

The Head of Strategic Sourcing leads a team of ~12 individuals focused on driving an efficient and effective Sourcing process. Responsibilities include the following areas Overall Responsibility Strategic Sourcing area Partners with the ELT to create a Sourcing vision and strategy that align with the needs of the business while meeting financial and operational control ob