Happy Halloween - Katalyst HLS

A Happy, Healthy and Fun Halloween - Katalyst HealthCares & Life Sciences

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Clinical Data Assistant - Boston, MA - KatalystHLS.com

Assists or develops data management plan components for study design and database content development. Responsible for eCRF testing, edit check development and configuration, documentation, and user training prior to going live. Develops and implements data management requirements within a study. Develops case report forms (CRF\'s), including validations and data collection processes.

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Clinical SAS Programmer, South Plainfield , NJ - Katalyst HLS

Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells. Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs. Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results. Perform programming validation to ensure quality of analysis datasets and programming outputs.

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Senior Clinical Data Manager, Boston , MA - Katalyst HLS

Responsible for timely and high-quality data management deliverables supporting client portfolio. Establish asset and study level strategies and services, including excellence in the application of standards. Conduct oversight using, predictive data monitoring practices from database activation through database release and submission. Contributes to the management of vendor partnerships to maximize effectiveness and maintain budgets. Provides and enables solutions for complex problem solving that align with the Client values. Serves as a clinical data management expert and provides guidance on CDISC standards.

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Post-Market / Sustaining Quality Engineer - Exton, PA - KatalystHLS.com

Post-Market Quality Engineer (QE) will provide technical quality leadership and support for client\'s Support transition of product licenses between Client locations and implementation of new MDR/IVDR Regulations. Katalyst HealthCares & Life Sciences Inc., visit us at www.KatalystHLS.com

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Careers at Katalyst HealthCares & Life Sciences

|| Careers at Katalyst HealthCares & Life Sciences || www.KatalystHLS.com

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Quality Engineer, Medical Devices - Katalyst HLS

Responsible for providing engineering and technical support to the Quality Department. Support a wide array of activities related to Change Control, Client/CAPA, Product Surveillance, New Markets and Risk Management. Evaluate the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations and recommend where corrections or improvements are indicated. Provide direct support to Quality personnel regarding operation of the department and Quality System. Provide support to other departmental activities as directed.

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Pre-Approval CMC Specialist - Katalyst HLS

Reporting to the Associate Director, the Sr. Specialist is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance\'s and defined regulatory strategies. The Senior Specialist is responsible for the preparation and review of information required for development of regulatory CMC dossiers for commercial products.

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Validation Specialist, Katalyst HealthCares & Life Sciences.

The ideal candidate will have experience with IQ/OQ/PQ validations or data integrity (access control for equipment use, auditing deleted data records). The Validation Specialist will be responsible for assessing systems throughout the clinical packaging site and generating the supporting documentation to confirm they meet the current regulatory requirements of data integrity. The role involves managing validation activities to ensure that all critical facilities, utilities, systems and processes remain in compliance with applicable regulatory requirements and industry standards.

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CMC Regulatory Submissions II, Manager - Katalyst HLS

Execution of global CMC Regulatory Submissions operational activities in support of pipeline programs (IMPD/CTA/IND), commercial programs such as Marketing Applications (NDA, MAA, BLA, JNDA) and Agency request for information, and Post- Approval changes to ensure continuous supply assurance, compliance submissions and process improvement are filed in a timely manner. Initiate and facilitate kick-off meetings, authoring of submission sections, review cycles, ensure content verification and traceability to source documentation. Operational activities in electronic systems like EDMS (Baxedge), Please Review, Premier (MS Project) to enable submission preparation and finalization by the SMEs and reviewers/approvers. Coordinate and confirm that all CMC Submission documents are submission ready for final publishing.

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Statistical Programmer, Katalyst HLS

Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells. Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs. Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results

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Regulatory CMC Specialist - Katalyst HLS

Reporting to the Associate Director, the Sr. Specialist is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance\'s and defined regulatory strategies. The Senior Specialist is responsible for the preparation and review of information required for development of regulatory CMC dossiers for commercial products. #btn_share_social{ background: none !important; border-color: transparent !important; } Search for More Jobs Forward job

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Careers at Katalyst HealthCares & Life Sciences

Find your next great career opportunity at Katalyst Healthcares & Life Sciences Inc. Search for job openings today.

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Clinical Data Manager Lead - Katalyst HealthCares & Life Sciences

Overseeing the management of clinical trial databases from study start up to study closure at CRO (or when required, support other DMs) by performing the following activities: Review and understand protocol synopsis and attend if required any protocol review meetings and act as subject matter expert for proper data capture based on protocol requirements.

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Contract Clinical Program Manager - Katalyst HLS

In-depth understanding of the drug development process and Working knowledge of, and experience with, clinical trial design, conduct, data acquisition and reporting. Working knowledge of Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.

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Associate Director-Global Regulatory Affairs-Lead, Katalyst HLS

Responsible for working collaboratively with the Global Regulatory Lead (GRL) and cross functional project teams to ensure global regulatory strategies are developed and seamlessly executed upon, enabling successful filings with Health Authorities.

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Computer Systems Validation Analyst - Wilson, NC - Katalyst HLS

The IT Analyst supports the IT Quality & Regulatory Compliance operation, team members and major system development life cycle activities, including validation review and change control approval of IT systems.

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Quality Assurance Associate, IPQA - Durham, NC - KatalystHLS.com

Responsible for providing Quality Assurance oversight for Manufacturing, Packaging, Laboratory, Warehousing, Maintenance and Engineering, ensuring products and processes are in compliance with internal and external regulations and standards.

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Senior Product Safety, PV Associate - Edison, NJ - KatalystHLS.com

PSPV Senior Associate will perform activities relating to the collection, processing, follow-up, analysis, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for marketed products and investigational compounds.

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Veeva Data Migration Consultant - Katalyst HealthCares & Life Sciences Inc.,

Ensure that the migration of data structures and templates from MI to Veeva is smooth and can be successfully utilized in Veeva to minimize any disruptions in business processes.

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Validation Engineer, Junior - Katalyst HealthCares & Life Sciences Inc

Junior Validation Engineer will assist in authoring validation test protocols, updating SOPs, and supporting change requests as required by the Client Engineer. Execution of Installation/Operational Qualification Procedures, Cycle Development Protocols, Performance Qualification Protocols, and other such documents that may be deemed necessary by the Owner\'s Validation department.

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Senior Business Development Manager, Staffing - Katalyst HealthCares & Life Sciences Inc

We are looking for an ambitious and energetic Senior Business Development Manager – Staffing, who will be responsible for building market position by locating, developing, defining, negotiating, and closing business relationships with new clients in Life Sciences (Pharma/Biotech/Medical Device/Clinical Research) & IT industries. The primary goal is to increase staffing billable hours, total sales and gross profit through focused business development strategies and by opening new accounts.

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Job Listings | Katalyst HealthCares & Life Sciences

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Manufacturing Supervisor, Upstream - Katalyst HLS

Leads the floor upstream manufacturing of clinical and commercial products. Executes pre and post processing activities such as: clean of production equipment, including the operation of automated bioreactor, harvest and media prep skids. This position is accountable for executing the manufacturing processes in Contract Manufacturing Facility and/or Master Cell Banking Facility.

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Manufacturing Supervisor, Downstream - Katalyst HLS

This position is accountable for leading the execution of procedures for purification manufacturing and support area of manufacturing using SOP\'s and batch records. Operating production equipment for purification that may include process monitoring, purification and formulation.

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Automation Engineer, cGMP - Katalyst HLS

The Automation Engineer is responsible for automation hardware and software lifecycle management for manufacturing and laboratory systems. This includes the day-to-day management of automation software and hardware; supporting the specification, procurement, installation, commissioning, and qualification of new automation software and hardware; the development of operation and maintenance procedures; providing technical support to end user, quality, and maintenance personnel; and supporting the decommissioning of automation software and hardware to be retired. The Automation Engineer is quality centered and follows company standard operating procedures (SOPs) geared toward FDA and other applicable regulations and in-line with current good manufacturing practices (cGMPs).

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Senior Regulatory Affairs Consultant

Job Responsibilities: Direct and coordinate activities of assigned products within Regulatory Affairs encompassing developmental products and post-marketing commitments. Function as the primary contact for negotiations and interactions with the FDA and offer guidance and strategy to ex-US strategy and filings. Contribute to developing regulatory strategies to ensure the shortest FDA review and approval times for regulatory applications. Provide regulatory guidance to team during the course of strategy formulation and submission preparation. Coordinate and consult with other departments on the content, review, and assembly of regulatory documentation. Ensure consistency, completeness, and adherence to FDA standards for all regulatory submissions. #btn_share_social{ background: none !important; border-color: transparent !important; } Search for More Jobs Forward job

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Submission Publisher

Job Description: Minimum 4 years of eCTD publishing experience required Experience in eCTD publishing for low/medium complexity in one or more ICH region Experienced with IND and NDA eCTD submissions. #btn_share_social{ background: none !important; border-color: transparent !important; } Search for More Jobs Forward job

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Computer Systems Validation Specialist

Position Summary: Reporting into Technical Director of IT, the Validation Engineer will assure that computerized systems are qualified in a manner that satisfies company policies and regulations established by regulatory agencies such as FDA, EUHA, etc. The Validation Engineer will implement an effective and efficient validation strategy for the CLIENT IT function which will ensure that the scope of validation activities addresses business and compliance needs for all computerized systems at CLIENT. #btn_share_social{ background: none !important; border-color: transparent !important; } Search for More Jobs Forward job

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Congratulations to the Nobel Prize Winners 2018 in Physiology or Medicine_ Katalyst HealthCares & Life Sciences

The Nobel Prize in Physiology or Medicine 2018 was awarded jointly to James P. Allison and Tasuku Honjo \"for their discovery of cancer therapy by inhibition of negative immune regulation\".

https://www.nobelprize.org/prizes/medicine/2018/summary/

Process Development Specialist II - Waltham, MA - Katalyst HLS

Complete assigned activities relating to design/interpretation of scientific experiments in downstream process development. Performs in-process analytical instrument measurements of e.g. pH, conductivity, protein concentration by spectroscopic methods, SDS-PAGE.

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Validation Engineer, Pharma Computer Systems - Morristown, NJ.

Ensure satisfactory completion of assigned Validation Projects encompassing Could IT Infrastructure, Equipment, Instruments, Cleaning, and Process areas for the entire Validation Life-Cycle.

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Careers at Katalyst HealthCares & Life Sciences Inc., www.KatalystHLS.com

Find your next great career opportunity at Katalyst HealthCares & Life Sciences Inc. Search for job openings today.

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