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What You Will DoServe as Empowered OfficialSupervise a team of Global Trade professionals as a supervisor, mentor, trainer and coach; provide license guidance and managing workloads Work with the APS GT Director to identify critical licensing priorities for escalation, resolve releasability challenges, and manage internal and external customer support issues.
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A typical week might include leading and coordinating multi-territory plans (with specific focus on Mexico, Brazil, Australia and other key markets) to achieve the best possible coverage for Converse across Global Partners, while driving the strategy and budget planning for all related Communications events.
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Technical understanding of biopharmaceutical production, with experience in cell and gene therapy a plus. Providing Quality representation on internal bbb and external CMO/CLO cross functional teams for development, method transfer, and assay validation projects.
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Qualifications Previous experience in a hospital or medical field in central processing, inventory control or database entry preferred Strong organizational skills and attention to detail required Basic computer skills in Word, Excel, Outlook, and ability to learn NEDS’s internal systems including but not limited to True North.
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In the alternative, will accept a Bachelor’s degree or foreign equivalent in the specified fields plus 5 years of progressive, post-baccalaureate experience in the specified occupations.
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It is also critical that the Principal Client Onboarding Manager has excellent communication skills and executive presence, as communicating and coordinating across a diverse set of internal and external stakeholders is a core job responsibility.
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Dedication to ensuring a cohesive and inclusive culture led by an internal diversity, equity and inclusion council. Plus One, part of the Optum Workplace Well-being portfolio of services, provides fitness and well-being services to clients across a broad range of industries, driving employee engagement in health and wellness programs.
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The Clinical Trial Manager, Site Start-up will lead internal process improvements related to study start up activities to ensure clinical trials are executed with high quality standards in compliance with regulatory requirements, GCP, and company SOPs. This role is based in our Waltham, MA headquarters.
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Develop a Site Initiation Management Plan and coordinate regulatory and ethics committee submissions and perform day to day management of the study start up activities for clinical studies. Provides internal expertise in the early planning of study start-up to ensure proposed CRO timelines and committed milestones are accurate and achievable.
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Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets. Creates, manages, and archives central startup team tools and resources required to support startup team daily operations, communications, and records from study assignment to final handoff.
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Health care experience a plus including: BONENT Certified, Certified Hemodialysis Technician (CHT), Certified Nursing Assistant (CNA), Certified Medical Assistant (CMA) We also have dedicated training to become a Facility Administrator, and training to become a Regional Operations Director.
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Serves as a point of escalation for study teams and CROs for country and site activation issues. Reporting to the Director/Senior Director of Clinical Operations, the Clinical Trial Manager, Site Start-up is accountable for leading, directing and overseeing end-to-end start-up, site initiation and site activation in collaboration with key stakeholders across multiple complex studies in a fast-paced environment.
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A minimum 5+ years of experience in Clinical Operations roles within the Pharmaceutical and/or Medical Device Industry, with heavy concentration within clinical trial management and monitoring.
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Coordinate contract and budget negotiations between sites and internal function team and coordinate investigational product release authorization with quality assurance. The Clinical Trial Manager, Site Start-up role plays a significant contribution to the clinical trial execution and ability to meet the corporate study goals for the Company clinical programs.
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Develop, execute, and assess integrated strategic communications programs encompassing editorial content creation, media relations, digital communications, executive communications, publications, brand management, and marketing campaigns, for both internal and external audiences, leveraging various modalities and channels to reach different audiences and leveraging the skills and talents of the OCPA team.
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internal communications a plus jobs Company: Find Great People Fgp in Boston, MA
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