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Senior Healthcare Document Publisher

Newton, MA

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u003Cbru003ENewton, MAu003Cbru003Eu003Cbru003Eu003Cbru003Eu003Cpu003Eu003Cspanu003EOur Client is a clinical-stage pharmaceutical company focused on the discovery u003C/spanu003Eu003Cspanu003Eand development of novel first in-class drugs directed against nuclear transport targets for u003C/spanu003Eu003Cspanu003Ethe treatment of cancer and other major diseases.u003C/spanu003Eu003C/pu003Eu003Cpu003Eu003C/pu003Eu003Ch1u003Eu003Cstrongu003ESUMMARY:u003C/strongu003Eu003C/h1u003Eu003Cpu003Eu003Cspanu003EThe Senior Associate, Regulatory Operations is responsible various day-to-day functions related to document publishing, regulatory information management, and submission management among other tasks as required. Under the direction of the Director, Regulatory Operations, this individual will support various regulatory application types including INDs, NDAs and related amendments/supplements in eCTD format. The successful candidate will ensure submissions and related documentation are prepared in compliance with various health agency regulations and guidelines. This role will coordinate and liaise with external submission vendors to manage submission compilation, validation and dispatch.u003C/spanu003Eu003C/pu003Eu003Ch1u003Eu003Cstrongu003ERESPONSIBILITIES:u003C/strongu003Eu003C/h1u003Eu003Culu003Enu003Cliu003Eu003Cspanu003EElectronic document publishing, scheduling and coordination of various document complexities (clinical protocols/amendments, nonclinical reports, SAPS, CSRs, related regulatory documentation, etc.)u003C/spanu003Eu003C/liu003Enu003Cliu003Eu003Cspanu003ESupport various internal functional groups ensuring the compliant use of eCTD Authoring Templatesu003C/spanu003Eu003C/liu003Enu003Cliu003Eu003Cspanu003EPrimary user of Adobe Acrobat, 3rd-party plugins, eCTD Authoring Templates and related tools as requiredu003C/spanu003Eu003C/liu003Enu003Cliu003Eu003Cspanu003EEnsure tracking and archiving of regulatory filings, correspondence and related information for various regulatory applicationsu003C/spanu003Eu003C/liu003Enu003Cliu003Eu003Cspanu003EPerform U.S. and international regulatory research tasks as related to Regulatory Technology and Operationsu003C/spanu003Eu003C/liu003Enu003Cliu003Eu003Cspanu003EAttending internal team meetings to collect and organize potential upcoming publishing and submission tasksu003C/spanu003Eu003C/liu003Enu003Cliu003Eu003Cspanu003EParticipate in Regulatory initiatives aimed at improving internal regulatory standards, systems and proceduresu003C/spanu003Eu003C/liu003Enu003Cliu003Eu003Cspanu003EParticipate in creation, review and implementation of department SOPs, WIs, guides and checklistsu003C/spanu003Eu003C/liu003Enu003Cliu003Eu003Cspanu003ESpecial projects related to submissions metrics in the form of tracking, collating, analyzing and reporting of key submission statisticsu003C/spanu003Eu003C/liu003Enu003Cliu003Eu003Cspanu003ESupport ongoing eDMS reconciliation activitiesu003C/spanu003Eu003C/liu003Enu003Cliu003Eu003Cspanu003EHelp drive eDMS initiatives, functionality testing and training effortsu003C/spanu003Eu003C/liu003Enu003Cliu003Eu003Cspanu003EAssist with other Regulatory and adjacent technology projects, as requiredu003C/spanu003Eu003C/liu003Enu003C/ulu003Eu003Cpu003Eu003C/pu003Eu003Ch1u003Eu003Cstrongu003EQUALIFICATIONS:u003C/strongu003Eu003C/h1u003Eu003Culu003Enu003Cliu003Eu003Cspanu003E5 years of direct Regulatory Operations experience publishing, compiling, QC, Validating and coordinating electronic submissionsu003C/spanu003Eu003C/liu003Enu003Cliu003Eu003Cspanu003EElectronic document publishing and eCTD experience is requiredu003C/spanu003Eu003C/liu003Enu003Cliu003Eu003Cspanu003EMicrosoft Office Suite (key focus on Word, Excel and PowerPoint and Visio, Adobe Acrobat, TRS Toolbox (formerly ISI), archiving/ filing/RIM activities, Veeva Vault and authoring template experience highly desiredu003C/spanu003Eu003C/liu003Enu003Cliu003Eu003Cspanu003EeCTD viewing, validating, and general regulatory submission project management experience preferredu003C/spanu003Eu003C/liu003Enu003Cliu003Eu003Cspanu003EExcellent verbal and written communication skills requiredu003C/spanu003Eu003C/liu003Enu003Cliu003Eu003Cspanu003EAbility to work in a fast-paced environment that is primarily timeline-drivenu003C/spanu003Eu003C/liu003Enu003Cliu003Eu003Cspanu003EAbility to independently complete complicated and technical tasks using sound judgement within stated request period as well as work as part of a team environmentu003C/spanu003Eu003C/liu003Enu003C/ulu003Eu003Cimg src=****Hill Staffing Group},identifier:{@type:PropertyValue,name:Beacon Hill Staffing Group,value:102862539},jobLocation:{@type:Place,address:{@type:PostalAddress,addressCountry:US,streetAddress:,addressLocality:Newton,addressRegion:MA,postalCode:02458}}}

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