{"id":32167,"date":"2013-09-29T22:08:44","date_gmt":"2013-09-30T02:08:44","guid":{"rendered":"http:\/\/jetwit.com\/wordpress\/?p=32167"},"modified":"2013-09-29T22:09:38","modified_gmt":"2013-09-30T02:09:38","slug":"job-senior-advisor-clinical-japanese-fluency-ca","status":"publish","type":"post","link":"https:\/\/jetwit.com\/wordpress\/2013\/09\/29\/job-senior-advisor-clinical-japanese-fluency-ca\/","title":{"rendered":"Job: Senior Advisor Clinical – Japanese Fluency (CA)"},"content":{"rendered":"

Via JETAA Northern California<\/b>. Posted by <\/em>Kim \u2018Kay\u2019\u00a0 Monroe<\/a> (Miyazaki<\/a>-shi, 1995 -97)<\/i><\/strong>. Click here<\/a> to join the JETwit Jobs Google Group<\/a> and receive job listings even sooner by email.<\/em>
\n\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014<\/p>\n

Position<\/i><\/strong>: <\/em>Senior Advisor Clinical – Japanese Fluency<\/i>
\nPosted by<\/b>: <\/em>Abbott<\/i>
\nType<\/i><\/strong>: Full-time\/ Day shift<\/em>
\nLocation<\/i><\/strong>: <\/em>Santa Clara, California<\/i>
\nSalary<\/i><\/strong>: N\/A<\/em>
\nStart Date<\/i><\/strong>: N\/A<\/em><\/p>\n

Overview:<\/b>
\nAbbott 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.<\/p>\n

Primary Job Function:<\/b>
\nA 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.<\/p>\n

Core Job Responsibilities<\/b>
\nResponsible for compliance with applicable Corporate and Divisional Policies and procedures.<\/p>\n

\u2022Provide 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.<\/p>\n

\u2022Develop study protocols and able to lead scientific discussions leading to the protocol.\u00a0 Successfully finalize protocols to timelines. Able to innovate design and production of protocols to shorten timelines.<\/p>\n

\u2022Analysis data and write reports or lead both activities.<\/p>\n

\u2022Be able to individually as well as lead a scientific team in cross-functional preparation, conduct, and submissions of clinical trial activities.\u00a0 Able to strongly drive or lead cross-functional discussions towards a cohesive and scientifically sound trial design and protocol.<\/p>\n

\u2022Should be viewed as a leader on scientific and medical matters related to clinical trial design, strategy, management, and analysis of data.\u00a0 Be able to mentor other clinical scientists.\u00a0 Be able to manage up to two scientists to make their deliverables.<\/p>\n

Position Accountability \/ Scope<\/b>
\nThis 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.\u00a0 No financial, budgetary, and legal interactions are expected.<\/p>\n

Qualifications<\/b><\/p>\n

Minimum Education<\/b>
\n\u2022Advanced degree (PhD, MD, MS, DVM)<\/p>\n

\u2022Minimum Experience \/ Training Required<\/p>\n

\u2022At least 5 years of clinical trial experience.<\/p>\n

\u2022Must be fluent in reading, writing, and speaking formal Japanese.<\/p>\n

\u2022Significant Work Activities and Conditions Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)<\/p>\n

Travel<\/b>
\nYes, 15 % of the Time<\/p>\n

https:\/\/abbott.taleo.net\/careersection\/2\/jobdetail.ftl?lang=en&job=32089&goback=%2Egde_161940_member_275425995%20-%20%21<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Via JETAA Northern California. Posted by Kim \u2018Kay\u2019\u00a0 Monroe (Miyazaki-shi, 1995 -97). Click here to join the JETwit Jobs Google Group and receive job listings even sooner by email. \u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014 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 […]<\/p>\n","protected":false},"author":85,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[3,1],"tags":[],"class_list":["post-32167","post","type-post","status-publish","format-standard","hentry","category-jobs","category-uncategorized"],"aioseo_notices":[],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_shortlink":"https:\/\/wp.me\/pkZ7m-8mP","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/jetwit.com\/wordpress\/wp-json\/wp\/v2\/posts\/32167","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/jetwit.com\/wordpress\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/jetwit.com\/wordpress\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/jetwit.com\/wordpress\/wp-json\/wp\/v2\/users\/85"}],"replies":[{"embeddable":true,"href":"https:\/\/jetwit.com\/wordpress\/wp-json\/wp\/v2\/comments?post=32167"}],"version-history":[{"count":2,"href":"https:\/\/jetwit.com\/wordpress\/wp-json\/wp\/v2\/posts\/32167\/revisions"}],"predecessor-version":[{"id":32169,"href":"https:\/\/jetwit.com\/wordpress\/wp-json\/wp\/v2\/posts\/32167\/revisions\/32169"}],"wp:attachment":[{"href":"https:\/\/jetwit.com\/wordpress\/wp-json\/wp\/v2\/media?parent=32167"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/jetwit.com\/wordpress\/wp-json\/wp\/v2\/categories?post=32167"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/jetwit.com\/wordpress\/wp-json\/wp\/v2\/tags?post=32167"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}