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

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

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

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 Director of Federal Government Affairs will be a member of the US Federal Government Affairs and Policy team, which drives the company's policy agenda in Congress and the Administration. This role supports the Senior Director of Federal Government Affairs and plays a key role for the Government Affairs function. The Director will significantly contribute to the analys

Otsuka is seeking a Director, Global Clinical Development (GCD), who will be responsible for the design and oversight of clinical research programs and protocols for OPDC products under good clinical practices (GCP). This is a remote position. The incumbent will be responsible for the evaluation and clinical development of Rheumatology, Immunology and Specialty Medicine p

Description of our Company, Responsibilities, Duties and Required Qualifications 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 medica

Responsible for the strategy, implementation, relationship management, and daily activities for assigned channel accounts (Wholesalers, SP's, SD's, and Retailers) Highly involved in the development, negotiation, implementation and ongoing management of channel specific contract strategies including multiple Service Agreements (Master, Distribution, etc.) with pertinent wh

The Senior Director, Franchise Lead, Global Medical Affairs CNS Psychiatry will be responsible for developing and executing the strategic vision for a select group of assigned assets within our CNS Psychiatry TA portfolio. This key role will report to the CNS Therapeutic Head, Global Medical Affairs. Assets under this person's responsibilities may include treatments for s

Proven track record for consistently meeting or exceeding financial and/or other quantitative targets, as well as qualitative goals Self starter; ability to seek out relevant information, prioritize, and apply information to solve complex problems in the ecosystem Ability to assimilate and communicate complex clinical and product information Knowledge of and ability to su

Medical Science Liaison As an integral member of the ecosystem team for Otsuka's new ecosystem based customer engagement model, the Medical Science Liaison (MSL), contributes to the development of the ecosystem strategic plan and identifies key stakeholders that are vital to the ecosystem. The Medical Science Liaison (MSL) is a credible partner responsible for providing c