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Monitoring immigration-related issues before the Massachusetts appellate courts and filing amicus briefs when necessary; The Staff Counsel II will work under the direction of the Director of the Immigration Impact Unit and will work in close collaboration with other staff counsel in the IIU. The Staff Counsel II also provides immigration analysis and advice on individual cases, provides litigation support on post-conviction motions, and drafts amicus briefs in relevant cases.
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Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF). Deep understanding of drug development, study conduct processes, GCP and regulations related clinical data management as well as ICH guidelines, FDA/EU regulations.
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At least 6 years of experience as a patent attorney in-house or at an IP law firm supporting global IP matters related to prosecution (filing and securing patents) in a field(s) related to biology, chemistry or biochemistry, such as pharmaceuticals, health, etc.
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The ability to perform administrative skills such as typing, filing, copying, faxing, opening and sorting mail, coordinating appointments for the Sales & Catering Managers and answer telephones according to Four Seasons standards.
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Must have strong experience with Electronic Filing USPTO and/or international procedures, ability to prepare and file new U.S. and national stage applications, new PCT applications, and other responses in the PTO as required, knowledge of Microsoft Office Suite and the ability to learn the systems and databases used by the IP operations department and the firm.
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Maintain complete oversight of eTMF document filing, ensuring accuracy and compliance with company standards, Good Clinical Documentation Practices, and project-level Trial Master File Plan and Index.
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Completes general office work, including faxing, filing, mailing, correspondence, copying, ordering supplies, calendar management and mail distribution. An entry level role that typically requires little to no prior knowledge or experience, work is routine or follows standard procedures, work is closely supervised, and communicates information that requires little explanation or interpretation.
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At least 1 year of biosecurity experience (i.e. have worked in national security or US Department of Defense setting or with a government contractor on biosecurity work; this includes helping research or operational experience in bioweapons, pandemic preparedness, biodefense, dual-use synthetic biology, etc) and/or academic experience.
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ESSENTIAL FUNCTIONS:The ability to perform administrative skills such as typing, filing, copying, faxing, opening and sorting mail, coordinating appointments for the Sales & Catering Managers and answer telephones according to Four Seasons standards.
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Reporting to the Dean of Students, this role is responsible for administrative logistics for the Office of Student Affairs (Office of Student Success, Office of Student Services, Residential Life, Title IX, and the Student Center at Harvard Griffin GSAS.
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Responsibilities- Developing incoming projects for production, from estimating, to presentation of all necessary information to the programmer- Filing and managing all information relevant to the project, including pricing, drawings, specifications, correspondence, invoicing, etc.
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Build collaborative relationships with CROs; drive the timely filing of documents throughout the study cycle; provide process and/or tactical support for TMF-related remediation as needed.
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The bioanalytical and biomarkers study manger is a member of the clinical study team and will contribute to study start up, sample testing, data delivery and CRO management as it relates directly to supporting the PK, ADA and Biomarkers components of study, program and corporate timelines.
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Guides and ensures that the clinical study documentation (documents, images, and other digital content) is correctly filed and archived, and that the study is maintained in a trial master file (TMF), so that documentation of GCP compliance is available, if required by a regulatory agency.
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Coordinates digital archive filing in M-files on behalf of Manager's Office, including Ecumenical and Interfaith Relations and Massachusetts Committee on Publication. Filing of documents in M-files and contact information in Salesforce as directed.
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filing job Title: work study student Company: Suny Upstate Medical University in Boston, MA
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