Coordinates outsourcing activities across assigned clinical development programs.
Meets with project teams to gain an understanding of the scope of work and priorities of the various projects.
Works with study teams to determine overall outsourcing strategy.
Guides project teams through the outsourcing process and gives appropriate suggestions and advice on the best approach / best practices.
Implements defined outsourcing process to develop necessary documents; e.g., SOW template, transfer of obligations chart, payment schedule, kickoff meeting agendas, etc.
Formulates and harmonizes project scopes, plans, strategies, and budgets for assigned studies/programs.
Keeps up to date on outsourcing trends in the pharmaceutical industry in order to better establish financial and performance agreements.
Aids in the evaluation of potential outsourcing vendors (through effective bidding process and capabilities presentations).
30% Vendor/Alliance management:
Participates in scheduling, organizing, and facilitating kickoff meetings with vendors.
Participates and/or facilitates team meetings with vendors.
Supports the project teams to assure the quality and timeliness of deliverables through outsourcing.
Monitors and manages relationships with contracted vendors; facilitates the resolution of issues and conflicts.
Supports organizational governance activities with vendors.
Works with Project Teams to ensure outsourced clinical trial activities meet quality standards and expectations and adheres to applicable Corporate SOPs, WPs, policies, guidelines, and regulations.
Modifies and updates SOPs and WPs in supporting processes and documents as requested.
Ensures smooth and effective communication between the vendors and the company.
Facilitates the closure of each study/contract with the vendor, including a mutual assessment of performance.
Conducts business operational assessment of vendors.
20% Vendor selection and contract negotiation:
Guides and participates in the evaluation, selection, and negotiation of contracts for assigned studies/programs.
Manage outsourcing process to engage new and innovative suppliers, structure outsourcing model to adapt new clinical trial model.
Works with Project Managers and Project Teams to develop RFPs.
Works with Project Managers and Project Teams for all operational, scheduling, project budget and cost-saving considerations for assigned studies/programs.
Liaises with project teams to develop the Statement of Work (SOW) for each contract.
Requires excellent knowledge and understanding of the clinical trial process drug development process.
Excellent knowledge of global supplier oversight, regulatory requirements, and clinical service suppliers.
Solid knowledge of team-based management practices.
Proven ability to identify issues and develop solutions and complete negotiations with attention to detail.
Proven ability to think conceptually, assess process effectiveness, manage and motivate clinical development teams in the specifications, selection, and oversight of outsourced clinical services, as well as clinical service providers.
Strong communication skills.
Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). Microsoft Project a plus.
At Otsuka, we defy limitation, so that others can too.
We have an unwavering belief in doing more. In transcending expectations. In going above and beyondunder any circumstancesfor patients, families, providers, and for each other. Its this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. We believe that the bigger the challenge, the bigger the opportunity. We are doing everything in our power to live up to our mission of creating new products for better health worldwide in two important therapeutic categories: neuroscience and nephrology.
Our culture is rooted in our Japanese heritage and almost 100-year history. Otsuka-people live by the core principles of Jissho the achievement, completion, and discovery of truth; and Sozosei pursuing that which only Otsuka is capable of delivering. We approach our business and overcome challenges through perseverance, unconventional thinking and humility. Learn more about Otsuka Pharmaceutical Company on its global website at http://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.
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At Otsuka, our people are passionate about developing and delivering original products as part of a global holistic commitment to better health and well-being. We have two core businesses dedicated to achieving our goals: a pharmaceutical business and a nutraceutical business. The pharmaceutical business develops and markets products for the diagnosis and treatment of disease in the following areas: central nervous system, oncology, gastroenterology, ophthalmology and cardiovascular. The nutraceutical business is dedicated to maintaining and improving health through the use of foods and beverages that provide extra health benefits in addition to their basic nutritional value. Since the beginning, nearly 100 years ago, the Otsuka family sought to develop products that stood out from the crowd, by traveling down the paths of discovery where others were less likely to tread.
We believe our culture and our people are the differentiators that empower us to produce breakthrough results. This is what makes us a big venture company that takes risks and focuses on unmet medical needs in order to develop new and better therapeutic compounds. We harness the extraordinary cr...eative and innovative abilities of our people to solve problems differently, and to persevere until they find answers. We are in this for the long-haul. Otsuka is a highly ethical company. We adhere to the highest standards in how we develop and deliver our products, and in how we treat our most valuable assets: Otsuka-people. We encourage them to follow their dreams, as turning dreams into reality is at the core of everything we do. It paves the way ahead to achieve our shared purpose: impacting on human health to help people live better lives.