Regulatory Submission Publisher - Princeton, NJ -KatalystHLS.com

Roles and Responsibilities: Responsible for both Submission and Document Level Publishing. Responsible for the creation, assembly, and publishing of global electronic submissions, including MAAs/NDAs, INDs, CTAs, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, Renewals, etc. Knowledge of health authority procedures/guidance\'s regarding electronic submissions required. May interface with project managers, regulatory product managers, and or content authors to discuss submission preparation.

https://www.indeed.com/job/regulatory-submission-publisher-53c207c5aebebbf3

Principal SAS Programmer - Rumford, RI - katalysthls.com

Roles and Responsibilities: Convert study design and specifications into programs to support clinical trials. Validate SAS programs written by others. Assists Management in maintaining SOPs and work instructions relevant to SAS programming. Follow regulatory requirements and guidelines for the development, usage, and maintenance of programs to support regulatory submissions.

https://www.indeed.com/job/principal-sas-programmer-b7c53af9174fe76f

Computer System Validation Lead - San Diego, CA

Computer System Validation Lead - San Diego, CA

https://www.indeed.com/job/computer-system-validation-lead-dfe5039f442c70fc

Statistical Programmer - Rogers, AR - KatalystHLS.com

Apply SAS programming and analytical skills using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS Design, develop, evaluate, validate and modify computer programs using SAS to analyze clinical data Produce and deliver standard datasets, program edit checks, quality tables, figures and listings in a timely and high quality fashion Create and validate CDISC standard datasets Provide input in the design and development of clinical trial protocols, case report forms and clinical databases Work closely with clinical operations, data management and statisticians to generate statistical output - tables/listing/figures Liaise with vendors as needed to facilitate electronic data transfers and statistical programming

https://www.indeed.com/job/statistical-programmer-290c4c44a1be59f7

Clinical Data Manager - Bozeman, MT -KatalystHLS.com

Manage data from database design through delivery to Biostatistics for analysis. Interpret the study protocol and develops detailed specifications that include the event schedule and layout of new eCRF pages and builds forms in database system. Maintain data collection definitions and documents data entry guidelines to ensure consistency of data. Set up data review plans, develops data edit check routines, reviews data for missing and incongruent data and utilizes the query management system to facilitate data resolution and clean-up, Monitor the progress of study data, assesses for analysis milestones and releases data to Biostatistician for analysis.

https://www.indeed.com/job/clinical-data-manager-51b42f2a31aac0c8

Validation Engineer II - Somerville, NJ - KatalystHLS.com

Under general supervision, reviews specifications and determines the critical aspects of facilities, utilities, computer systems and manufacturing equipment with regard to product and process quality, writes qualification protocols for operating systems and records related test results; prepares final reports that identify the results of protocol testing and the conditions of release.

https://www.indeed.com/job/validation-engineer-ii-a569aadb114bafe5

Clinical Data Specialist - Boston, MA - KatalystHLS.com

Independently ensure all study data is validated in accordance with regional and federal clinical study guidelines. Oversee database design, testing, and optimization. Create and implement clinical trial methods for collecting and analyzing site- and patient-specific clinical trial data.

https://www.indeed.com/job/clinical-data-specialist-1f1eb1b4b7744585

Senior Clinical Data Manager/Client: Allergan - Madison, NJ - KatalystHLS.com

The Senior Manager, Clinical Data Management is responsible for leading internal and outsourced Clinical Data Management activities in support of Clinical Research studies, managing the definition of Case Report Form (CRF) requirements, creation of the Data Management Plan, coordination of Centralized Data Review activities (a key component of Risk Based Monitoring), and is accountable for data integrity, quality, and consistency at Database Lock.

https://www.indeed.com/job/senior-clinical-data-managerclient-allergan-e9676f4f7063437c

Clinical Data Manager - Bozeman, MT - KatalystHLS.com

Manage data from database design through delivery to Biostatistics for analysis. Interpret the study protocol and develops detailed specifications that include the event schedule and layout of new eCRF pages and builds forms in database system.

https://www.indeed.com/viewjob?t=clinical+data+manager&jk=51b42f2a31aac0c8&_ga=2.38037987.1326352972.1562606511-1429968906.1557248850

Manufacturing Quality Engineer - Costa Mesa, CA -KatalystHLS.com

Update the purchasing spec with compliance to the requirement from Central Remediation Team Coordinate with TPE team to complete the DFM review / alignment with external suppliers Initiate EC relevant to the change of the purchase parts

https://www.indeed.com/viewjob?t=manufacturing+quality+engineer&jk=38b209149910970e&_ga=2.75378002.1326352972.1562606511-1429968906.1557248850

Lead Regulatory Publisher - Atlanta, GA -KatalystHLS.com

Produce regulatory publishing submissions (e.g., INDs, NDAs, NDSs, MAAs, annual reports, routine submissions, Clinical Study Reports) in accordance with US and global requirements, using electronic publishing tools, and an EDMS system. Perform independent publishing QC on published output, complete appropriate checklists and/or provide assessments for the activities around the quality of report-level publishing and submission readiness of source documents for submission-level publishing.

https://www.indeed.com/viewjob?t=lead+regulatory+publisher&jk=6b3e4123e8334bea&_ga=2.80677975.1326352972.1562606511-1429968906.1557248850

Project / Program manager - Gaithersburg, MD - KatalystHLS.com

The Project Manager (PM) consultant will support 2 to 3 projects depending on the stage and complexity level of the program. Project assignments will include pipeline, life cycle management, technology and/or continuous improvement initiatives. In this role the PM will work with limited direction and will effectively prioritize and manage their workload to meet Team goals.

https://www.indeed.com/viewjob?t=project+program+manager&jk=ce5eb3ceb6535bb9&_ga=2.74984914.1326352972.1562606511-1429968906.1557248850

Documentation Coordinator/ Client: Allergan - Pleasanton, CA - KatalystHLS.com

The primary responsibility of this position is assisting with processing documentation in a controlled document management system and assigning training to personnel to meet regulatory, quality and company requirements in a medical device design and manufacturing environment.

https://www.indeed.com/viewjob?t=documentation+coordinator+client+allergan&jk=bdcf7640aec52cb1&_ga=2.120867912.1326352972.1562606511-1429968906.1557248850

Drug Safety Specialist - Westbrook, ME - KatalystHLS.com

Conduct the assessment of all serious individual adverse event case reports stemming from pre-clinical studies, post-marketed and literature sources. Performs quality control of key data fields, and makes updates in the safety database per process conventions Executes case assessment (review events, determine expectedness, review/update drug and medical term coding, determine causality) Creates clear, medically concise case narrative procured from relevant information in form of various source documents Drafts pharmacovigilance company comment Determines follow-up actions and generates letters/queries as appropriate

https://www.indeed.com/viewjob?t=drug+safety+specialist&jk=e0a8f642e0d79a81&_ga=2.45614436.1326352972.1562606511-1429968906.1557248850

Quality Engineer - Cleveland, MS -Katalyst HLS.com

Gather project requirement and understand the scope of each project. Able to lead risk management activities including creation/update of Risk Management Plan, Hazard Analysis, Design FMEA, Product User Risk Analysis, Risk Benefit Analysis and Risk Management Report Support Internal/external Audit. Able to record Audit observations, and closure of the same. Understand and perform the product complaint analysis, Customer Quality procedures Supports Quality, Manufacture, Service, and Marketing departments on product Quality issues. Perform statistical analysis using statistical software like Minitab

https://www.indeed.com/viewjob?t=quality+engineer&jk=74aa1e2077a89887&_ga=2.113011140.1326352972.1562606511-1429968906.1557248850

Senior Engineer (Client: Allergan) - Somerville, NJ -KatalystHLS.com

Consultants will provide hands-on expertise to revise and document the Quality Management System, Clinical, Post-Market Surveillance, and Supplier Management processes as necessary for compliance with the European Union Medical Device Regulations (EU MDR). In addition, medical device technical files will be reviewed to ensure use of prohibited hazardous substances are in accordance with the limits set forth in the General Product Safety Requirements (Annex I), and records will be created as necessary to fulfill the requirements of the various Annexes.

https://www.indeed.com/viewjob?t=senior+engineer+client+allergan&jk=374d5d6ec7c8584c&_ga=2.50801001.1326352972.1562606511-1429968906.1557248850

Statistical Programmer - Albuquerque, NM - KatalystHLS.com

Apply SAS programming and analytical skills using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS Design, develop, evaluate, validate and modify computer programs using SAS to analyze clinical data Produce and deliver standard datasets, program edit checks, quality tables, figures and listings in a timely and high quality fashion Create and validate CDISC standard datasets

https://www.indeed.com/viewjob?t=statistical+programmer&jk=3fc990aaed8ac1fa&_ga=2.50670697.1326352972.1562606511-1429968906.1557248850

Clinical SAS Programmer - Rockville, MD - KatalystHLS.com

Clinical SAS Programmer - Rockville, MD - KatalystHLS.com Develop SAS macro libraries to standardize routine analysis or implement new methods. Manage the Clinical SAS Programming Team, maintain standards for Clinical SAS programming activities, and guide/coach the Clinical SAS Programmers.

https://www.indeed.com/viewjob?t=clinical+sas+programmer&jk=25e313def12bcf9d&_ga=2.105719235.1326352972.1562606511-1429968906.1557248850

Clinical SAS Programmer - Albuquerque, NM - Katalyst HLS

Write and manage SAS code for mapping clinical data to SDTM data structures in conformance with Emmes\' SDTM Implementation Guide, project standards, and the study protocol Create DEFINE specifications for mapping of SDTM and ADaM compliant datasets Review and QC submission ready SDTM datasets, define.xml, and supporting documentation, as appropriate Provide CDISC training and serve as a subject matter support to project staff

https://www.indeed.com/viewjob?t=clinical+sas+programmer&jk=91e2055a4d36b31e&_ga=2.37506144.1326352972.1562606511-1429968906.1557248850

Clinical SAS Programmer - Albuquerque, NM - Indeed.com

Clinical SAS Programmer - Albuquerque, NM

https://www.indeed.com/viewjob?t=clinical+sas+programmer&jk=91e2055a4d36b31e&_ga=2.11815668.1326352972.1562606511-1429968906.1557248850

Regulatory Affairs Coordinator-Boston, MA - KatalystHLS.com

Demonstrated ability to coordinate complex projects. Strong oral and written communication and presentation skills Solid working knowledge of the US Regulations and European medical device directives Good analytical and problem-solving skills. Demonstrate in-depth understanding of advanced technical/scientific principles related to MDR IVD reagent chemistry, laboratory automation, and software components of MDR / IVD medical devices.

https://www1.jobdiva.com/portal/?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&compid=0&jobid=12937328

Validation Expert - Winston-Salem, NC - KatalystHLS.com

Author and review process validation protocols and reports. Support execution of validation activities at the shop floor. Reviews Master Batch Records and associated change controls. Maintain all activities and projects under own responsibility in an inspection ready status. Provides technical expertise (and may facilitate) pre-validation risk assessments using risk management tools.

https://www.indeed.com/viewjob?t=validation+expert&jk=63798748bf39c2e2&_ga=2.47009255.1326352972.1562606511-1429968906.1557248850

Validation Engineer - Houston, TX - KatalystHLS.com

Role Summary/Purpose Internal the Quality Engineer demonstrates leadership in communicating, developing, and executing program schedules, process developments, and analysis in various organizational settings regarding internal and external business goals.

https://www.indeed.com/viewjob?t=validation+engineer&jk=47ab02ea6dea93a5&_ga=2.12994039.1326352972.1562606511-1429968906.1557248850

QA COMPLAINT SPECIALIST - Austin, TX - KatalystHLS.com

They will be responsible for answering inbound calls and collecting all pertinent information for the complaints. They essentially are responsible for asking the Who, What, When, Where, and How can we assist questions. They are the front-lines of the business, so they must have excellent customer service skills, be able to type without looking at the key board with a low error rate.

https://www.indeed.com/viewjob?t=qa+complaint+specialist&jk=799a5181abb5988c&_ga=2.154170872.1335194151.1562012451-1429968906.1557248850

QA COMPLAINT SPECIALIST - Austin, TX - KatalystHLS

QA COMPLAINT SPECIALIST - Austin, TX -KatalystHLS

https://www.indeed.com/viewjob?t=qa+complaint+specialist&jk=799a5181abb5988c&_ga=2.154170872.1335194151.1562012451-1429968906.1557248850

Clinical Reporting Lead (Client: Allergan) - Irvine, CA - KatalystHLS.com

Under the direction of management, the Clinical Reporting Lead will lead the design, development, validation, rollout of reports/dashboards using business intelligence tools (e.g., Spotfire, J-Review, Power BI) and programs (e.g., SQL, PL-SQL, R, SAS) used in Clinical Research and Development studies. Additionally

https://www.indeed.com/viewjob?t=clinical+reporting+lead+client+allergan&jk=5a5bf866eb873482&_ga=2.120609096.1335194151.1562012451-1429968906.1557248850

QA Complaint Specialist (Client: Allergen) - Pleasanton, CA - KatalystHLS.com

The primary responsibility of this position is the investigation, analysis, resolution, trending of all complaints. Specific responsibilities include; maintaining the complaint files and providing excellent customer service. Essential Duties and Responsibilities include the following.

https://www.indeed.com/viewjob?t=qa+complaint+specialist+client+allergen&jk=adea9890a77c68a8&_ga=2.186260585.1335194151.1562012451-1429968906.1557248850

DOCUMENTATION COORDINATOR II, (Client: Allergen) - Somerville, NJ - KatalystHLS.com

We are looking for a new round of candidates. The main things the previous candidates were lacking were more around the data collection and data migration activities. The couple of candidates who did have these skills didn\'t not have them with a Quality system (e.g. doc management system, TrackWise, etc.), they were more along the business systems such as Oracle or SAP. We are looking for candidates with documentation management experience within EDMS systems. They need to be well versed in data collection, metrics reporting, TrackWise workflow have experience with performing data analysis and data migration activities for enterprise scale Quality systems (1-2 systems preferred).

https://www.indeed.com/viewjob?t=documentation+coordinator+ii+client+allergen&jk=6d4fc10cb8eb7fa6&_ga=2.143160821.1335194151.1562012451-1429968906.1557248850

Technical Writer II - Irvine, CA - KatalystHLS.com

Gathers, analyzes, and composes information provided by subject matter experts (SME). Conducts research and ensures the use of proper technical terminology. Translates SME information into clear, readable documents and process maps to be used by users Ensures consistency, clarity, and quality in and across all types of documentation. Engages in formatting, editing, and quality assurance on own work and the work of others.

https://www.indeed.com/viewjob?t=technical+writer+ii&jk=85e837b80ee206e2&_ga=2.142818421.1335194151.1562012451-1429968906.1557248850

Regulatory Affairs Specialist- IVDR - Houston, TX - KatalystHLS.com

The Regulatory Specialist will support the Hematology, Urinalysis, and Flow Cytometry business units in meeting conformity to the EU In Vitro Diagnostic Regulation (IVDR). As a regulatory process expert supporting the IVDR teams, implements regulatory strategies for IVDR activities; Provides regulatory leadership in experimental designs, data analysis and product labeling as related to registration and commercialization of in vitro diagnostic devices; collaborates with the regulatory staff from other business units, companies, government agencies and Product Regulatory Subcommittees as needed to develop harmonized policies, procedures and work instructions for IVDR compliance.

https://www.indeed.com/viewjob?t=regulatory+affairs+specialist+ivdr&jk=ecb574eed39421f2&_ga=2.75632981.1335194151.1562012451-1429968906.1557248850

Quality Assurance –CSV - South Plainfield, NJ 07080 - KatalystHLS.com

The candidate must have experience in Quality Assurance –CSV area and be familiar with FDA guidelines and GAMP regulations. 6-8 years experience in QA area is preferred. Must possess excellent communication skills including working well with others and writing skills.

https://www.indeed.com/viewjob?t=quality+assurance+csv&jk=454dfa0691dbbfe1&_ga=2.113389639.1335194151.1562012451-1429968906.1557248850

Clinical Data Manager - Rochester, MN - KatalystHLS.com

Manage data from database design through delivery to Biostatistics for analysis. Interpret the study protocol and develops detailed specifications that include the event schedule and layout of new eCRF pages and builds forms in database system. Maintain data collection definitions and documents data entry guidelines to ensure consistency of data.

https://www.indeed.com/viewjob?t=clinical+data+manager&jk=9a89763423937cd8&_ga=2.152598009.1335194151.1562012451-1429968906.1557248850

Quality Engineer - Mesa, AZ

Experience in validating the Laboratory Equipment, Computerized System. ISO 13485 standards experienced. Well acquainted with all the phases of Validation Life Cycle (VLC). Expertise in planning and execution of Validation Master Plan, requirements gathering. Expertise in technical writing and reviewing of Standard Operating Procedures (SOPs), Work Instructions.

https://www.indeed.com/viewjob?t=quality+engineer&jk=f35d0662cefa70c2&_ga=2.219821529.1335194151.1562012451-1429968906.1557248850

Quality Engineer - Mesa, AZ

Experience in validating the Laboratory Equipment, Computerized System. ISO 13485 standards experienced. Well acquainted with all the phases of Validation Life Cycle (VLC). Expertise in planning and execution of Validation Master Plan, requirements gathering. Expertise in technical writing and reviewing of Standard Operating Procedures (SOPs), Work Instructions.

https://www.indeed.com/viewjob?t=quality+engineer&jk=f35d0662cefa70c2&_ga=2.219821529.1335194151.1562012451-1429968906.1557248850

Clinical Data Manager II - Austin, TX - KatalystHLS.com

Acts as a lead data manager for one or more projects and a liaison to the PM and /or client as required. Essential Functions and Other Job Information: Applies relevant components of the project protocol to daily tasks and directs others on how to apply to their daily tasks. Acts as an interdepartmental and client liaison for all DM study activities. Produces project-specific status reports for CDM management, PM and/or clients on a regular basis.

https://www.indeed.com/viewjob?t=clinical+data+manager+ii&jk=222b8d4e98c61975&_ga=2.85307289.1824577181.1561870312-1429968906.1557248850