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Support the team implementing the Global Talent Management (GTM) communications strategy, inclusive of campaigns across Learning & Development, Decision Science, and Talent Access organizations, in alignment with the global HR communications strategy and with consideration for broader enterprise communications initiatives.
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Our staff consists of only four people-an Internal Support Staff and Projects Coordinator, Communications Director, Strategy Director and Executive Director. Our staff consists of only four people-an Internal Support Staff and Projects Coordinator, Communications Director, Strategy Director and Executive Director.
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The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
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Position Summary: The Director, Clinical Systems and TMF Operations is a member of the Clinical Business Operations team within the Development Operations organization and is responsible to provide strategic leadership and oversight of Trial Master File (TMF) Operations, Records Management, and Clinical Systems & Technology (CS+T) utilized across clinical programs.
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Apply model-based drug development strategy to support clinical dose and dosing regimen selection, facilitate clinical study design and support regulatory submissions. The Director of Clinical Pharmacology role within Clinical Development organization will provide leadership and expertise to support assigned clinical pharmacology projects in the clinical development programs for an expanding portfolio of small, biological and inhaled molecules across several disease areas.
$179,000 - $250,800 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The TLL will work closely, and within approved SOPs, with other field professionals, including but not limited to the National Sales Director and Regional Managers, in addition to home office-based colleagues in Marketing, Medical Affairs, Sales, and Market Access.
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Partner with SME organizations to identify source documents and negotiate delivery of approved technical documents in accordance with project timelines and aligned with CTD requirements and regulatory strategy.
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The Associate Director- Cell Therapy Sales, Operations, & Mid/Long-Term Supply Planning is a key contributor to a GSC organization that leads and drives business critical business processes of Sales, & Operations Planning (monthly), detailed monthly drug product planning/scheduling activities (monthly), and Long-Term Supply & Capacity Planning (semi-annually.
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The Director, Medical Affairs NA - Biologics Lead will report to the AVP, Medical Affairs NA - Biologics and Market Access, and be a key medical resource in developing and implementing the medical affairs strategy for biologics.
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Lead the business responsibility and accountability for ERP system improvements, change management, and drive site technology strategy, roadmap development and execution. Collaborate with J&J and Legend Biotech IT business partners to ensure a lean, agile, and right-first-time implementation of ERP / TranSCend within Cell Therapy manufacturing.
$76,000 - $121,900 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
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The Position is an individual contributor role in the Cloud Governance Business Office (CGBO) within the Platforms Architecture Cloud & Tools (PACT) organization that is part of GTS Technology Strategy & Planning.
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Initial draft authoring of scientific content for Common Technical Document (CTD) Quality sections and responses to health authority questions aligned with regulatory strategy for cell therapy clinical CMC regulatory submissions based on high quality technical reports.
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Proven success in healthcare recruiting - Clinical & Allied including but not limited to APRN, RN, LPN/LVN, Director level, OT/PT, SLP, Techs, Medical Lab & Diagnostic Imaging professionals. Undergraduate degree preferred in Business, Marketing, Management, Communications, Public Relations, Healthcare Administration or Licensed RN.
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This individual will be responsible for delivering CMC documentation (Dossier and supporting documents) to support the regulatory strategy for the Cell Therapy clinical portfolio from early stage through registrational application.
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business strategy human hr director jobs Title: human partner in Somerset, NJ
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