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Administracja biurowa » Pracownik biurowy

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Global PDR Director PHC & FMI Nr ref.: /JOBS.pl The Global PD Regulatory Director is in the Global Product Development Regulatory Affairs (PDR) organization and reports to a PDR Leadership Team member. This is primarily an individual contributor role with possibly 1-2 direct reports. The purpose for this role is to lead regulatory strategic support for personalized healthcare (PHC) development and launches with an emphasis on the immediate launch of Roche Pharma's Foundation Medicine (FMI) service in countries and territories outside the US. This role is global and can be based at any site and international travel is required. The individual is a member of the cross functional FMI Taskforce and an ad hoc member of the applicable Regulatory Affairs Functional Teams (RAFTs). The individual also provides strategic advice to PDR Leadership Team and acts as PDR SPOC for strategy for PHC / molecular information for cross functional groups active around FMI topics and PHC. Short Term and Long Term Activities: FMI Service Report Short-term needs (2016): Facilitate "label" agreement between FMI and Roche Global, and between Roche Global and affiliates regarding the FMI service report provided to physicians and Establish common model by which affiliates can localize the service Long-term needs (2017+): Consider alternative models to localize service offering (may not be same as localized reporting above) Influencing regulatory framework for personalized healthcare in partnership with ongoing influencing efforts in Roche Pharma and Diagnostics: Identify stakeholders within relevant global (ex-US) regulatory agencies Partner closely with PDR Policy/Roche Diagnostics Policy and FMI on ongoing policy efforts in US and EU Understand how global (International ex-US) regulatory agencies see comprehensive genomic profiling and information services like FMI or other clinical decision support software Provide feedback to the International ex-US team on how regulators may wish to see the service offering evolve for maximum impact/alignment Support the international rollout by working with ex-US global Roche Regulatory affiliate personnel to engage global (ex-US) regulatory agencies to achieve Roche/Genentech/FMI's vision for profiling Certifications & approvals: Short-term needs (2016): Coordinate to provide any additional support needed by Roche Diagnostics who are currently advising FMI Task Force and may require additional feedback on regulatory setup for specific initiatives Long-term needs (2017+): Clarify regulatory oversight which applies to service and support Universal Companion Diagnostic project Who you are You're someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.The individual must be capable of working in a matrixed and de-centralized environment across many key internal stakeholder groups as well as across Roche Pharma, Roche Diagnostics, our many affiliates and Foundation Medicine, Incorporated (FMI). The individual must have skills that result in effective influence in the absence of a reporting line. Minimum Requirements: Bachelor's Degree required (life sciences disciplines strongly preferred) 15 or more years' relevant experience in regulatory affairs or related functions in drug/biologics development/manufacturing/diagnostics Extensive knowledge of GxP (Good Practices for quality guidelines and practices in the pharmaceutical/biotechnology or related industry), GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA, NICE and other relevant guidelines including diagnostic regulations/guidelines Extensive experience working with the principles and techniques of data analysis, interpretation and clinical relevance In-depth familiarity with competitive activity in the field Experience participating in global product development teams and regulatory affiliates Strong computer and technology skills Fluent English and other language skills as needed Who we are Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites.Read more. Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law. Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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