Job: Senior Advisor Clinical – Japanese Fluency (CA)
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Via JETAA Northern California. Posted by Kim ‘Kay’ Monroe (Miyazaki-shi, 1995 -97). Click here to join the JETwit Jobs Google Group and receive job listings even sooner by email.
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Position: Senior Advisor Clinical – Japanese Fluency
Posted by: Abbott
Type: Full-time/ Day shift
Location: Santa Clara, California
Salary: N/A
Start Date: N/A
Overview:
Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people.
Primary Job Function:
A senior-level scientist that is fluent in reading, writing, and speaking formal Japanese is needed to provide clinical science support for both coronary and core medical devices in Japan. This support consists of (a.) actively participating in Japan strategy meetings, (b.) writing/translating protocols or Informed Consent Forms (or amendments), clinical study reports, and publications, (c.) providing clinical trials.gov updates for all Japan clinical trials (required by US Public Law 110-85), (d.) attending clinical trial team meetings (conducted in Japanese), (e.) addressing PMDA regulatory questions about clinical data, (f.) liaising with top interventional cardiologists to provide scientific support, (g.) updating investigator brochures or IFUs, (h.) supporting Japan audits, (i.) providing scientific support to the commercial team, and (j.) attending Japanese investigator or advisory board meetings.
Core Job Responsibilities
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
•Provide scientific leadership to the team, advising on different aspects of trial strategy and design and data analysis, and mapping of a variety of scenarios for a robust strategy and plan.
•Develop study protocols and able to lead scientific discussions leading to the protocol. Successfully finalize protocols to timelines. Able to innovate design and production of protocols to shorten timelines.
•Analysis data and write reports or lead both activities.
•Be able to individually as well as lead a scientific team in cross-functional preparation, conduct, and submissions of clinical trial activities. Able to strongly drive or lead cross-functional discussions towards a cohesive and scientifically sound trial design and protocol.
•Should be viewed as a leader on scientific and medical matters related to clinical trial design, strategy, management, and analysis of data. Be able to mentor other clinical scientists. Be able to manage up to two scientists to make their deliverables.
Position Accountability / Scope
This position will require significant interactions with cross-functional teams within (Biostatics, RA, Clinical Operations, Data Management, Safety, etc) and outside (R&D, strategic marketing) clinical-regulatory organization, and some interactions with principal investigators in the trials. No financial, budgetary, and legal interactions are expected.
Qualifications
Minimum Education
•Advanced degree (PhD, MD, MS, DVM)
•Minimum Experience / Training Required
•At least 5 years of clinical trial experience.
•Must be fluent in reading, writing, and speaking formal Japanese.
•Significant Work Activities and Conditions Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 15 % of the Time
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