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The Clinical Chaplain facilitates communication with caregivers outside the healthcare team; serves as a subject matter expert in pastoral care matters and collaborates with community clergy to provide ongoing spiritual support.
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Advance Degree (Ph. D., MD, Sc. D, MA/MS or MPH) in a medical/biomedical/scientific discipline with a minimum of 3 years of scientific experience; OR Bachelor’s Degree, preferably in life sciences with 7 years of relevant work experience in a medical device/clinical environment required with a technical or professional health services licensure from an accredited licensing entity strongly preferred (e.g., RT, RCIS, RN); OR equivalent combination of education and experience.
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Familiarity with clinical data standards, including CDISC, SDTM, and ADaM , and experience with clinical trial data management systems (e.g., EDC, CTMS). Provide insights on clinical data standards (e.g., CDISC, SDTM, ADaM) and ensure that data models and analytics adhere to regulatory and operational guidelines.
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Set-up, organize, and maintain clinical study documentation (e.g. Trial Master File documents, clinical study site documents, email correspondence, training materials, etc.
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In partnership with the research community and other biomedical and clinical informatics specialists, the successful candidate will manage and analyze data being created in molecular and cellular biology, genomics and biomedicine through the use of existing data science and machine learning tools as well as engineer new toolsets that include models, algorithms, and software developed in-house.
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Expertise in IBM FileNet suits of products such as IBM Content Manager, IBM Case Manager, IBM Content Navigator, CMIS, IBM Content Collector for file systems and emails. Expertise in IBM FileNet suits of products such as IBM Content Manager, IBM Case Manager, IBM Content Navigator, CMIS, IBM Content Collector for file systems and emails.
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Catalent Pharma Solutions in Somerset, NJ is hiring a Master Scheduler for the Supply Chain Department. Partner with Production Planner and Project Managers to understand client and project demand and translate requirements into long range master schedule.
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Must have Bioanalytical experience so they can help lab troubleshoot issues when applicable, Outsourcing experience preferred but the major focus/must haves should be at least years (with masters or higher degree) or years (with bachelors degree) bioanalytical experience, regulated experience, experience supporting clinical studies, biomarker ops or analysis.
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Bachelor's degree or equivalent experience background in publishing processes and automation, with an emphasis in IT Help desk using the following Google mail, XML, Word, Excel, Unix, databases, PostScript, and PDF file creation.
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IT System Administration/Vault Owner in Veeva vault (Quality, RIM, Clinical), learning management system (ComplianceWire), validation lifecycle management system (ValGenesis), electronic signature systems (DocuSign.
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Lead, direct, coach, and develop an effective Operations team responsible for daily clinical and commercial production of autologous and allogeneic cell therapy products, while ensuring safe and compliant operations according to cGMP requirements.
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In-vitro biofilm models and cutting-edge assessment tools will be developed by the Senior Scientist that are predictive of clinical outcomes, provide mechanistic insights or generate new, scientifically robust, claims.
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Development and update of departmental procedures, PMS documents as part of the Technical File (e.g. PMS Report, PSUR, PMS Plan Prepare Post Market Surveillance (PMS) documents as part of the Technical File (e.g. PMS report, PSUR, PMS Plan) and other ad-hoc PMS aggregate reports.
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Bioreactor, bioreactors, upstream, biochemical, clinical batches, bags, tube sets, columns, process manifolds, biosimilars, recombinant proteins M3. The upstream scientist is responsible for executing cell culture batches from 50 L to 1000 L volumes, engineering and clinical batches in a cGMP environment.
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The Associate Director will work closely with HEOR team members and others across the company including market access, marketing, medical affairs, and clinical development to support Insmed's business needs.
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clinical master file jobs Title: master in Raritan, NJ
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