Computerized System Validation Consultant, MA - KatalystHLS.com

CSV Contractor is responsible for assuring Computerized System Lifecycle (CSLC) projects, are in compliance to company procedures and applicable regulations. The CSV Contractor will be an individual contributor and take a business partnership approach with key internal/external stakeholders to ensure quality of CSLC processes while enabling innovation, productivity, and continuous improvement.

https://www.indeed.com/viewjob?t=computerized+system+validation+consultant&jk=6023fbbfb1041cb4&_ga=2.120579009.87449381.1538317238-1408033885.1530798869

Associate Director, Quality Management, Process and Training - Katalyst HLS

In conjunction with subject matter experts, develop departmental training topics, Continually update GTMM content and training materials to include technology and procedural changes as they occur. Assist with development of all departmental presentations and handouts and circulate via approval process prior to deployment to the staff. Introduce innovative delivery methods of training, track success upon implementation, and provide metrics to management.

https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=11771058&SearchString=&StatesString=&jobseq=21&rowsperpage=30&divisions=&divisions2=

Regulatory Documentation Associate, MA - Katalyst HLS

Primary responsibilities include: coordinating documentation for worldwide regulatory submissions; report level publishing, eCTD hyperlinking and QC checks, oversight and /or technical support of nonclinical document preparation including electronic submissions.

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Senior Quality Engineer, IL - Katalyst HLS

Product Quality Engineer applies a solid understanding of theories/practices utilized by other disciplines outside the primary area of expertise toward the development of new or enhanced products. The Quality Engineer will lead from a technical quality perspective to support product development, design change control and verification/validation activities. This position requires a functional understanding of FDA, ISO and Quality systems.

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Lead Statistical Programmer, NJ - Katalyst HLS

Lead statistical programming activities as Trial Programmer for 1-2 studies or assigned project level activities. If assigned to cross-project aligned group (e.g. Standards), manage at least one, macro/utility function or local project. Co-ordinate activities of all programmers either internally or externally (FSP, CRO) assigned to the study/studies. Make statistical programming recommendations at study level. Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope), e.g. as member of the Clinical Trial Team.

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Senior Clinical Operations Associate, CA - Katalyst HLS

Participate in reviewing and testing of specifications and edit checks for the electronic data capture (EDC) system. Review eCRF completion guidelines and lab requirements. Work with Data Management and Clinical Standards to ensure data collection meets standard. Develop and deliver study specific training presentations at study start and provide ongoing training to the sites during study conduct, as needed. Review/author informed consent forms and support their submission to IRBs.

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Quality Engineer - II, Katalyst HealthCares & Life Sciences

Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) in design and production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.

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28 September is World Rabies Day - Katalyst HLS

28 September is World Rabies Day It is celebrated annually to raise awareness about rabies prevention and to highlight progress in defeating this horrifying disease. 28 September also marks the anniversary of Louis Pasteur\'s death, the French chemist and microbiologist, who developed the first rabies vaccine. Today, safe and efficacious animal and human vaccines are among the important tools that exist to eliminate human deaths from rabies while awareness is the key driver for success of communities to engage in effective rabies prevention.

http://www.who.int/rabies/WRD_landing_page/en/

Clinical Data Manager, Senior - Boston, MA - www.KatalystHLS.com

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.

https://www.indeed.com/viewjob?t=clinical+data+manager+senior&jk=fe61887f7ecbce4b&_ga=2.61970277.875287865.1538219097-1408033885.1530798869

Regulatory Affairs Specialist, Greater Boston Area, MA - Katalyst HLS

Prepare Central IRB and/or ethics committee submissions (protocol, amendments, consents, investigator brochures, safety updates) for assigned studies. Review essential trial documents to ensure accuracy, completeness, and compliance with ICH/GCP guidelines, local SOPs, and sponsor requirements.

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Director R&D Process Documentation Lifecycle Management job - Katalyst HealthCares & Life Sciences, MA |

Establish and maintain cross functional forum to ensure currency and alignment of R&D process models and supporting documents. Define standards for content of Procedural Documents and Process Models and develop and deploy training that ensures those standards are consistently implemented across R&D. Effectively manage the workload of the Lifecycle Management & Support Leads (LMSL) to ensure efficient and timely process documentation completion and approvals. Oversee the controls for processing GxP controlled documents and templates, including consistently applying formatting and standards across all document types while utilizing best practices for technical writing.

https://www.indeed.com/viewjob?t=director+rd+process+documentation+lifecycle+management&jk=7631959a2ba8bc96&_ga=2.198797615.106787379.1537634786-1408033885.1530798869

Clinical Data Assistant - Greater Boston Area - Katalyst HLS

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.

https://www.indeed.com/viewjob?t=clinical+data+assistant&jk=78f997b3ce3a6e19&_ga=2.227558685.106787379.1537634786-1408033885.1530798869

R&D Process Lifecycle Management and Support Lead , MA - Katalyst HLS

The Consultant Procedural Document Facilitator/Quality Management System Specialist will be responsible for leading and executing activities related to procedural document development and training within R&D QA & Compliance, R&D as a whole, with touch points across the company.

https://www.indeed.com/viewjob?t=rd+process+lifecycle+management+and+support+lead&jk=33eb847761ca2dc4&_ga=2.163734207.106787379.1537634786-1408033885.1530798869

Clinical Data Analyst job - Katalyst HealthCares & Life Sciences - Greater Philadelphia

Ensure timely delivery of appropriate and consistent coding of all clinical study AE and Medication data to facilitate meeting project timelines. Undertake coding and review of verbatim terms when necessary to successfully meet project timelines Ensure coders adhere to establish processes/procedures Communicate progress and issues related to coding assignments to Head, Dictionary Group and DML/CDM (as appropriate) Assist in identifying and implementing new dictionaries and software improvements (dsNavigator, eDM, etc.) Assist in development and maintenance of Dictionary SOPs and Working Instructions. Assist Coders in writing and resolving dictionary queries

https://www.indeed.com/viewjob?t=clinical+data+analyst&jk=c1e1b4d567e15bb9&_ga=2.43291877.1156104345.1537126170-1408033885.1530798869

Senior Quality Specialist - III

Job Description: Responsible for ensuring that all Client Therapeutic Protein and Biological products managed by BQOEM are manufactured, packaged, analyzed, released stored and distributed in accordance with Client expectations and all applicable regulatory requirements.
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Regulatory Affairs Manager

Job Description: Serve as the lead device regulatory affairs member of project development teams, primarily focused on (but not limited to) device products. Provide regulatory oversight and guidance to project teams on compliance matters, FDA requirements, clinical study design issues and on timing, logistics and operational recommendations for product development.
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Validation Analyst

Job Description: The validation analyst will provide an advisory role as needed. Advising clients on assigning proper risk to computer systems Advising clients on how to meet compliance requirements.
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Talent Acquisition Specialist, Pharma/Medical Device - Remote & Raritan, NJ

This position will be a Remote position, to cover recruiting of Sales positions in the Western and Central regions of the US. Interview prospective employees and evaluate candidates for employment related to factors such as job experience, education and training, knowledge, skills and abilities, organizational culture considerations, and other data pertinent in selection for a wide variety of non-exempt and exempt positions in multiple functional disciplines.
https://www.indeed.com/viewjob?t=talent+acquisition+specialist+pharmamedical+device+remote&jk=5535cffef9a5bf23&_ga=2.236931649.1946429564.1536544940-1408033885.1530798869

Quality Engineer, Medical Devices - Minneapolis, MN - Katalyst HLS

To provide design quality and reliability support for European Medical Device Regulation (EU MDR) assessment of design history file deliverables and risk management remediation / state of the art for Interventional Lung Solutions (ILS) products, provide engineering expertise on cross-functional teams and collaborate with other Healthcare and external engineering groups.
https://www.indeed.com/viewjob?t=mdr+quality+engineer&jk=b44c44f370e0fc34&_ga=2.203793872.1946429564.1536544940-1408033885.1530798869

Quality Control Analyst I - Thousand Oaks, CA - Katalyst HLS

Conduct specific biological, chemical and physical analyses on pharmaceutical products (biologics and drugs) and medical devices through all stages of the manufacturing process from incoming raw materials to finished goods, and may include environmental monitoring programs.
https://www.indeed.com/viewjob?t=quality+control+analyst+i&jk=324d5f38578503e4&_ga=2.141495922.1946429564.1536544940-1408033885.1530798869

Regulatory Consultant, Medical Device MDSS - Carlsbad, CA.

Individual must plan, implant and ensure compliance of the Technical File to the medical device regulation. Must have expertise of registering products with one of the EU authorized representatives. Expert in Technical Files. Minimum 5 years expereince.
https://www.indeed.com/viewjob?t=regulatory+consultant+medical+device+mdss&jk=78645894c381171b&_ga=2.58306858.1217839535.1536065202-2077807285.1533320279

Regulatory Specialist, Medical Device Registrations - Carlsbad, CA.

Individual must plan, implant and ensure compliance to global registration in terms of change in the legal manufacturer. Ensure proper time invested to re-register products globally. Expert in global registration.
https://www.indeed.com/viewjob?t=regulatory+specialist+medical+device+registrations&jk=1c560c04d81e96e9&_ga=2.58306858.1217839535.1536065202-2077807285.1533320279

Regulatory Specialist, Medical Devices ISO & MDSAP - Carlsbad, CA.

Individual must ensure that the requirements for ISO 13485:2016 / Medical Device Single Audit Program (MDSAP) are incorporated into the Quality Management Systems (QMS). Individual must plan, implant and ensure compliance to Medical Device Single Audit Program (MDSAP).
https://www.indeed.com/viewjob?t=regulatory+specialist+medical+devices+iso+mdsap&jk=878234731cd3b6bf&_ga=2.58306858.1217839535.1536065202-2077807285.1533320279

Medical Writer, Clinical Research - Lexington, MA.

Medical Writer (MW) is responsible for medical writing activities related to clinical documents (eg, investigators brochures, study protocol and amendments, study reports, marketing authorization submission documents).
https://www.indeed.com/viewjob?t=medical+writer+clinical+research&jk=0c379025f5041591&_ga=2.54197544.1217839535.1536065202-2077807285.1533320279

Post Market Surveillance Specialist, Medical Devices - Carlsbad, CA.

Individual must ensure that the requirements for post market surveillance reports are met through creating reports and obtaining data such as Risk Assessments, Clinical Evaluation Reports, Complaints, Vigilance, Medical Device Reports, CAPAs etc. by working with the cross functional teams.
https://www.indeed.com/viewjob?t=post+market+surveillance+specialist+medical+devices&jk=1821c0dbad9f8b90&_ga=2.58306858.1217839535.1536065202-2077807285.1533320279

Senior Regulatory Affairs Consultant, Medical Devices - Carlsbad, CA.

Individual must plan, implant and ensure compliance to EU MDR. Lead cross-functional teams. Coordinate activities/tasks and resources across affected departments. Identify gaps and resolves issues related to EU MDR. Expert in EU MDR. Minimum 10 years expereince.
https://www.indeed.com/viewjob?t=senior+regulatory+affairs+consultant+medical+devices&jk=46351922cf239142&_ga=2.92010522.1217839535.1536065202-2077807285.1533320279

Argus Technical Consultant - Irvine, CA - www.KatalystHLS.com

Argus Technical Consultant role engages with IT and business for the Argus migration activities. Conduct user requirement gathering for Argus migration and transform user requirements to functional requirements leading into migration and system design. Develop business process workflow diagrams and system level logical/physical architecture diagrams.
https://www.indeed.com/viewjob?t=argus+technical+consultant&jk=0c6115ecf1f3e705&_ga=2.139292275.1982000693.1535723830-2077807285.1533320279