Regulatory Affairs Specialist job - Katalyst HealthCares & Life Sciences

Responsibilities: Coordinate, prepare, and follow up with FDA Premarket Notification [510(k)] submissions in a timely manner. Act as liaison with FDA regarding product clearance. Assess necessity for submitting a 510(k) application for proposed device changes. Prepare internal "Non-Filing Justifications” (U.S.) for changes that do not require a 510(k) submission. Prepare technical files for CE marking with appropriate input/help from various functions (R&D, Quality, Manufacturing, etc.) in a timely manner. Submit notification to the Notified Body about significant changes to CE marked products in a timely manner. Review/approve labeling, promotional and advertising materials to ensure regulatory compliance. Reviews clinical protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance.
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10817250&SearchString=&StatesString=&jobseq=0&rowsperpage=30&divisions=&divisions2=

Regulatory Affairs Specialist, AdPromo job - Katalyst HealthCares & Life Sciences - Boston, MA | Indeed.com

January 27, 2018 - Regulatory Affairs Specialist, AdPromo - ul li US Regulatory Advertising and Promotion (US Reg AD/Promo) is responsible for actively contributing to the implementation of regulatory
https://www.indeed.com/viewjob?t=regulatory+affairs+specialist+adpromo&jk=054aa655543f5f12&_ga=2.238509888.1598299858.1517244655-251423520.1515107595

Regulatory Specialist, Medical Devices Katalyst HLS

Job Description Job Description: Ensure compliance to local regulations and policies. Implement NPI & develop the regulatory submission plan. Support data analysis, mapping and migration activities from legacy systems Oversee preparation and review registration documents to ensure the submissions meet appropriate standard and content requirement. Interact with regulatory agency actively to expedite approval of pending application and to resolve regulatory matters. Provide regulatory affairs support during internal & external audit. Provide regulatory affairs support during internal & external audit.
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10805969&SearchString=&StatesString=&jobseq=2&rowsperpage=30&divisions=&divisions2=

Clinical Study Manager I Katalyst HLS

MAJOR RESPONSIBILITIES: Supervise and/or oversee all study-related procedures to ensure they are carried out in accordance with protocol and regulatory guidelines. Provide status updates regarding projects to clients and other departments. Review draft protocol and coordinate operations in order to meet protocol requirements. Manage pre-defined study timelines and be proactive in identifying delays and possible solutions to meet deadlines. Collaborate with other departments to create study specific procedures and forms as per guidelines. Approve initiator configuration. Provide appropriately QC'd study raw data to Medical Writing team for report completion. Perform quality control of clinical reports by utilizing protocol and procedural deviations reports, sample inventory, and medical writers. Participate in the revision of SOPs.
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10806028&SearchString=&StatesString=&jobseq=0&rowsperpage=30&divisions=&divisions2=

SENIOR CLINICAL TRIAL MANAGER – ONCOLOGY Kattalyst HLS

POSITION SUMMARY: Functions as the clinical study team leader to plan, organize, and coordinate all operational aspects of a clinical study from protocol development through database lock. Ensures timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials. KEY RESPONSSIBILITIES: Responsible for the preparation and finalization of project and study related documents including: informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments, IND Annual Updates and clinical summaries, as required Responsible for the selection of investigators and study sites responsible for identifying and responding to site and study related issues and recommending corrective actions and/or escalating to
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10805996&SearchString=&StatesString=&jobseq=1&rowsperpage=30&divisions=&divisions2=

Clinical Trials Manager Katalyst HLS

Position Summary: The Clinical Trials Manager is responsible for the day-to-day activities associated with managing clinical studies. Working closely with the Associate Director, Clinical Operations and collaborating with colleagues in other functions, the Clinical Trials Manager supports the operational team to ensure excellent operational oversight of clinical studies. The Clinical Trials Manager contributes to and manages the project plans, manages and oversight of vendors, performs tasks during protocol design to final CSR, to produce high-quality study data, adherence to Good Clinical Practice and to achieve corporate goals on time and on budget. Roles and Responsibilities: Manages clinical studies, including vendor management and oversight including CROs, IRB, DSMB. Organize and participate in investigational meetings and site training. Coach and mentor all staff under him/her; set objectives, solicit 360° feedback from stakeholders and conduct performance reviews to foste
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10805896&SearchString=&StatesString=&jobseq=0&rowsperpage=30&divisions=&divisions2=

Design Quality Engineer job - Katalyst HealthCares & Life Sciences - Somerville, NJ

January 24, 2018 - Design Quality Engineer - p b Job Description: /b /p ul li Hands on experience in FDA regulated Design Control, Change Control, NPD flow, Risk Management activities. /li
https://www.indeed.com/viewjob?t=design+quality+engineer&jk=2c96eaaf0da03c13&_ga=2.188887723.1037664947.1516836011-251423520.1515107595

Regulatory Affairs Associate job - Katalyst HealthCares & Life Sciences - Boston, MA

January 24, 2018 - Regulatory Affairs Associate - p b Responsibilities: /b /p ul li Support the regulatory affairs (RA) systems /li li Organize and maintain data and information held in
https://www.indeed.com/viewjob?t=regulatory+affairs+associate&jk=cacfdf9d3eb966e2&_ga=2.92430237.1037664947.1516836011-251423520.1515107595

Regulatory Affairs Associate job - Katalyst HealthCares & Life Sciences - Piscataway, NJ

January 24, 2018 - Regulatory Affairs Associate - p b Responsibilities: /b /p ul li Support the regulatory affairs (RA) systems /li li Organize and maintain data and information held in
https://www.indeed.com/viewjob?t=regulatory+affairs+associate&jk=9e872b940adc08d4&_ga=2.88103579.1037664947.1516836011-251423520.1515107595

Clinical Studies Operations Lead job - Katalyst HealthCares & Life Sciences - Gaithersburg, MD

January 24, 2018 - Clinical Studies Operations Lead - p b Roles & Responsibilities: /b /p ul li Contribute to the planning of projects where required, by coordinating protocol development in
https://www.indeed.com/viewjob?t=clinical+studies+operations+lead&jk=ebfda211794d6378&_ga=2.122952587.1037664947.1516836011-251423520.1515107595

Regulatory affairs Specialist job - Katalyst HealthCares & Life Sciences - Chicago, IL

January 22, 2018 - Regulatory affairs Specialist - p b Essential Duties and Responsibilities: /b /p ul li Utilizing gathered legacy medical device technical files, construct a draft STED file
https://www.indeed.com/viewjob?t=regulatory+affairs+specialist&jk=dd9c194f0d2d969a&_ga=2.75864277.1712953499.1516661677-251423520.1515107595

Regulatory Affairs Manager job - Katalyst HealthCares & Life Sciences - South Plainfield, NJ

January 22, 2018 - Regulatory Affairs Manager - p b JOB DESCRIPTION: /b /p ul li Prepare and manage the regulatory submissions process for all assigned projects/products throughout the
https://www.indeed.com/viewjob?t=regulatory+affairs+manager&jk=76389526b03af22e&_ga=2.83344598.1712953499.1516661677-251423520.1515107595

Regulatory Operations Associate job - Katalyst HealthCares & Life Sciences - Boston, MA

January 22, 2018 - Regulatory Operations Associate - p b Job Description: /b /p ul li We are seeking a Regulatory Operations professional with a solid background in document formatting and IND
https://www.indeed.com/viewjob?t=regulatory+operations+associate&jk=3a9ad9ed0154a073&_ga=2.155695611.1712953499.1516661677-251423520.1515107595

Clinical Research Document Specialist II job - Katalyst HealthCares & Life Sciences - Cambridge, MA

January 22, 2018 - Clinical Research Document Specialist II - p b Job Description: /b /p ul li Generation, maintenance (including follow up for documents) and finalization of Trial Master File Table of
https://www.indeed.com/viewjob?t=clinical+research+document+specialist+ii&jk=e4ad26e077676d9c&_ga=2.86995288.1712953499.1516661677-251423520.1515107595

In-house Clinical Research Associate job - Katalyst HealthCares & Life Sciences - Raritan, NJ

January 22, 2018 - In-house Clinical Research Associate - p b Job Description: /b /p ul li The In-House Clinical Research Associate will work closely with the Lead CRA and Investigational Sites by
https://www.indeed.com/viewjob?t=+house+clinical+research+associate&jk=834e93f68912f95a&_ga=2.80041943.1712953499.1516661677-251423520.1515107595

Verification & Validation Engineer job - Katalyst HealthCares & Life Sciences - Waukesha, WI

January 22, 2018 - Verification & Validation Engineer - p b Job Description: /b /p ul li Responsible for coordination and execution of validation studies in accordance with current Good Manufacturing
https://www.indeed.com/viewjob?t=verification+validation+engineer&jk=f68864d7cb10ab23&_ga=2.158317946.1712953499.1516661677-251423520.1515107595

Clinical Data System Specialist Katalyst HLS

Responsibilities: Administer GxP research/clinical systems Perform installation and testing for vendor applications/patches Manage changes, deviations, CAPAs management and release processes for applications in a regulated environment Facilitate resolution of Tier 2 and 3 application issues Participate in business and issue analysis with business, validation, IT and QA.
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10785523&SearchString=&StatesString=&jobseq=0&rowsperpage=30&divisions=&divisions2=

Clinical Data Manager Katalyst HLS

Roles and Responsibilities: Interact both verbally and through written communication with inter-organizational and outside customer contacts as well as with Central and External laboratories, CROs, etc. Contribute to the design of protocols. Develop eCRF specifications according to protocol and approved standards (based on industry standards), participate in user acceptance testing. Develop protocol specific edit check specifications, participate in user acceptance testing. Develop and maintain project- specific Data Management plan throughout the life-cycle of the study protocol, which includes CRF annotation, database specifications, edit checks and other pertinent data management documents.
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10785522&SearchString=&StatesString=&jobseq=0&rowsperpage=30&divisions=&divisions2=

Senior Clinical Data Manager Katalyst HLS

Essential Skills: Strong experience with effective oversight of DM vendors in complex drug development programs, preferably oncology experience. Regulatory submissions and audit ​experience very beneficial. Effective project management ​DM ​skills to ensure compliance to both quality and timeline expectations. Ability to ​Lead and ​support multiple studies concurrently with minimal oversight by functional manager Proven ability to closely collaborate with cross-functional team members Strong cross-functional understanding on the impact of data management processes to other stakeholders. Has a good understanding of regulatory guidelines and issues (i.e., ICH GCP), and understands the connection to DM deliverables.
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10785506&SearchString=&StatesString=&jobseq=0&rowsperpage=30&divisions=&divisions2=

Clinical Trial Management (CTM) Analyst Katalyst HLS

Description: Clinical Trial Management (CTM) Analyst is responsible for supporting systems/processes within the Clinical Trials Management Solutions team such as Clinical Trial Management System (CTMS) and Grants Manager. Work with Study Teams and partners during study build process to create/maintain the following in CTMS Study, Country, Site, Contacts, and Institution records Create and set up templates such as Health Authority, IRB/IEC, Financial Disclosure, Subject Visit, Visit/Trip Report, etc. Update system dropdown values Create/Update assignments, configurations, properties, attributes, triggers, and parameters in the system. User administration Import/Export templates Add Payees and study triggers Visit Schedules Subject deviations/central findings Any other general study build activities Troubleshoot integration errors between CTMS and other applications
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10785502&SearchString=&StatesString=&jobseq=1&rowsperpage=30&divisions=&divisions2=

Mechanical Engineer (Medical Device) Katalyst HLS

Job Description: Bachelor's degree in Mechanical Engineering or Biomedical Engineering. 5+ years' experience in medical device related R&D. Experience designing and testing mechanical systems. Experience leading pre-clinical testing of devices and supporting clinical testing of devices. Experience with hands-on prototyping, test methods/experiments, and data analyses. Excellent interpersonal skills are required for satisfying internal customers (e.g. in supporting Marketing, Manufacturing Engineering, Quality). Experience successfully utilizing CAD & analytical design to drive development such as Finite Element Analysis (FEA).
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10779529&SearchString=&StatesString=&jobseq=0&rowsperpage=30&divisions=&divisions2=

Regulatory Affairs Associate - I KatalystHLS

Job Description: Responsible for maintaining the Endnote Repository Library by adding new references, searching for citations, and modifying references if necessary. Also adding reference articles, abstracts, presentations to the Regulatory Document Management System (RDMS). Should possess some knowledge of a document management system. Other responsibilities include electronic quality control (eQC). This entails verifying Acrobat PDF's are submission ready by validating hyperlinks, bookmarks, document properties, and overall look of the document. General knowledge of Adobe Acrobat is preferred.
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10779350&SearchString=&StatesString=&jobseq=2&rowsperpage=30&divisions=&divisions2=

Manufacturing Quality Engineer Katalyst HLS

Understand and apply FDA CFR 820, ISO 13485, ISO 14971, Canadian, Japanese, Brazilian and European medical device regulations. Provide quality engineer support to ensure that products are manufactured with a high level of quality, while being in compliance with standards and regulations governing medical device manufacturing. Administer and manage delivery holds and reconciliations for assigned product lines. Provide support for field actions as needed. Develop, review and approve procedures, technical/validation reports, change notices, risk assessments, and other related quality system documentation. Lead, support, or facilitate investigations, CAPAs, process changes, quality plans and other Quality activities. Lead or support internal and external quality system audits. Drive resolution of nonconformities.
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10778307&SearchString=&StatesString=&jobseq=4&rowsperpage=30&divisions=&divisions2=

Clinical SAS Programmer KatalystHLS

ESSENTIAL DUTIES: Assist Biometrics Department with developing tools and techniques for improving process efficiencies. Performing quality assurance procedures on work performed by others. Review statistical analysis plans and protocols. Contribute to the development and documentation of analysis/clinical data set specifications, safety and efficacy analysis programming, as well as any ad-hoc programming requests. Develop and maintain Programming standard and custom data listings, summary tables, and graphs as specified in statistical analysis plan. Implement and follow the latest versions of CDISC, FDA guidelines, Good Clinical Practice, and other industry standards. Provide input into case report form design, database structure design, and edit check development.
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10778249&SearchString=&StatesString=&jobseq=5&rowsperpage=30&divisions=&divisions2=

Drug Safety Associate Katalyst HLS

Description: Minimum 3 years' experience; preference for someone who has worked at multiple companies Nursing or pharmacy background strongly preferred Needs to have experience with the full case processing workflow (mailbox experience/assessing & triaging cases, data entry experience, quality check/review experience, follow up experience as well as submissions experience) Argus database experience is an absolute must; experience with reports and listings in Argus, as well as experience coding AE and medication within Argus would be nice to have Candidate would need to have a strong attention to detail, good communication skills, and ability to assess and think critically
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10770737&SearchString=&StatesString=&jobseq=2&rowsperpage=30&divisions=&divisions2=

Quality Engineer Katalyst HLS

Job Description: 6-8 years of Quality engineering experience. Quality Engineering experience in Medical Devices (at least in Class I & II) at least 3 years. Full Quality System Knowledge. Extensive Gage R&R experience. Process FMEA. Process Control Plan Measurement System Analysis Studies (Gauge R&R). Process Capability Analysis (Cpk). Process Qualification (e.g. IQ, OQ, PQ). First Article Inspection (FAI). First Production Inspection (FPI). Critical to Quality (CTQ).
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10770726&SearchString=&StatesString=&jobseq=3&rowsperpage=30&divisions=&divisions2=

Verification & Validation Engineer KAtalyst HLS

Mandatory Technical Skills: Experience as a Verification and Validation Engineer for 5+ years XRAY product testing experience [System Testing experience mandatory] Strong knowledge of Microsoft Windows technologies Strong belief in quality compliance and following rules Strong working experience on setting up lab test equipment and setting up PC and Servers and deploying software onto target systems Knowledge of testing medical products Knowledge of FDA regulations required to test medical products Expertised in quality reviews
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10770705&SearchString=&StatesString=&jobseq=4&rowsperpage=30&divisions=&divisions2=

Regulatory Affairs Specialist job - Katalyst HealthCares & Life Sciences - Boston, MA ||

January 12, 2018 - Regulatory Affairs Specialist - p b SRS Application Specialist (Submission Ready Standard Application): /b /p ul li Under the direction of the line manager the SRS specialist
https://www.indeed.com/viewjob?t=regulatory+affairs+specialist&jk=f4e88c291b7fb787&_ga=2.131919627.522784933.1515452185-251423520.1515107595

Associate Director, Global Regulatory Affairs (CMC) job - Katalyst HealthCares & Life Sciences - Boston, MA ||

January 12, 2018 - Associate Director, Global Regulatory Affairs (CMC) - p b Description: /b /p ul li The CMC Regulatory Affairs Network Strategy Implementation Team Lead will provide leadership and be the Regulatory
https://www.indeed.com/viewjob?t=associate+director+global+regulatory+affairs+cmc&jk=a667477e4c6121d3&_ga=2.125091982.522784933.1515452185-251423520.1515107595

Clinical SAS Programmer job - Katalyst HealthCares & Life Sciences - Downingtown, PA ||

January 3, 2018 - Clinical SAS Programmer - p b JOB DESCRIPTION: /b /p p b Roles & Responsibilities: /b /p ul li Assist Biometrics Department with developing tools and techniques for
https://www.indeed.com/viewjob?t=clinical+sas+programmer&jk=07a785726e1932b7&_ga=2.91480862.522784933.1515452185-251423520.1515107595

Senior Regulatory Consultant Katalyst HLS

Main Duties: Successful Global Regulatory Submissions and Approvals, including 510(k)s and Technical Documentation Review by Notified Body in EU. Prepared product registrations for various countries and/or provided additional information to regulatory bodies for successful registration of products. Reviewed design and labeling changes to assess regulatory impact, filed various submissions and updates with regulatory agencies. Maintained up to date regulatory requirements for the business unit (Registrations/Regulatory Audits/Quality Manual/Quality System Certificates). Prepared and submitted 510(k)'s, IDEs, and other applicable product submissions according to FDA guidelines.
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10763921&SearchString=&StatesString=&jobseq=5&rowsperpage=30&divisions=&divisions2=

Regulatory Publishing Manager, Insight Publisher Katalyst HLS

Responsibilities: Work as part of a global Regulatory Operations team, contributing to global filings. Lead key submissions for EU, Switzerland and Emerging Markets. Compilation and publishing of submission dossiers for Europe and the emerging markets for clinical trials, paediatrics and marketing applications. Work closely with submission content providers to advise on submission content, structure, planning and strategy. Work with publishing vendors. Regulatory submission source document review, formatting, & troubleshooting, including but not limited to, MS Office, Adobe Acrobat PDF, Acrobat Plug-ins and XML ensuring documents conform to style guide and internal/external regulations.
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10763903&SearchString=&StatesString=&jobseq=6&rowsperpage=30&divisions=&divisions2=

Document Management Coordinator Katalyst HLS

Position Roles & Responsibilities: 5 years of work experience is required, and Commercial Sponsorship Coordinator Specialist will be responsible for overseeing the compliant execution, process management and administration for the electronic approval system supporting Sponsorship and Exhibit requests. Oversight for activities such as coordinating training, identifying and resolving systematic and process issues and concerns, partnering with key business stakeholders and the third party service provider(s) to enhance the system's effectiveness and efficiency, monitoring transactions, document flow, approvals and exceptions and developing report Serve as a key compliance resource for stakeholders across the commercial organization.
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10763824&SearchString=&StatesString=&jobseq=7&rowsperpage=30&divisions=&divisions2=

Regulatory Affairs Specialist Katalyst HLS

Job Details: This position is responsible for the preparation of regulatory submissions required to market new or modified medical devices in both the U.S. And Europe, and related regulatory affairs activities, such as development, execution and management of procedures and systems designed to ensure that the product development process, including clinical studies, addresses all regulatory requirements as well as the objectives of the business. Requires the analysis of data, problem solving analysis and in depth evaluations of various factors. May provide leadership by assigning work and resolving complex problems.
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10764547&SearchString=&StatesString=&jobseq=2&rowsperpage=30&divisions=&divisions2=

Regulatory Publishing Manager, Insight Publisher job - Katalyst HealthCares & Life Sciences - Remote

January 11, 2018 - Regulatory Publishing Manager, Insight Publisher - p b Job Description: /b /p ul li The Senior Associate is responsible for facilitating product development and global registration through the
https://www.indeed.com/viewjob?t=regulatory+publishing+manager+insight+publisher&jk=3a2ca024eaafc3fd&_ga=2.196273064.522784933.1515452185-251423520.1515107595

Manager Regulatory Affairs Submissions job - Katalyst HealthCares & Life Sciences - South Plainfield, NJ

January 8, 2018 - Manager Regulatory Affairs Submissions - p b Summary: /b /p ul li The Manager, Regulatory Affairs (Submissions) contributes to the strategic planning and preparation of regulatory
https://www.indeed.com/viewjob?t=manager+regulatory+affairs+submissions&jk=2ae9d737166aabad&_ga=2.124055438.522784933.1515452185-251423520.1515107595

Regulatory Affairs Specialist job - Katalyst HealthCares & Life Sciences - Boston, MA

January 8, 2018 - Regulatory Affairs Specialist - p b Responsibilities: /b /p ul li Represents Regulatory Affairs on Post-Market RA Team for the Point-of-Care Business Area. /li li Support
https://www.indeed.com/viewjob?t=regulatory+affairs+specialist&jk=c3cdd2f7b2f0bbcd&_ga=2.120701068.522784933.1515452185-251423520.1515107595

Senior Clinical SAS Programmer job - Katalyst HealthCares & Life Sciences - South Plainfield, NJ

January 8, 2018 - Senior Clinical SAS Programmer - p b JOB DESCRIPTION: /b /p ul li Hands-on skills in legacy data conversions to CDISC SDTM data sets, good working experience in generating CDISC
https://www.indeed.com/viewjob?t=senior+clinical+sas+programmer&jk=913b2898d35e6359&_ga=2.191531950.522784933.1515452185-251423520.1515107595

GCP Engineer, Reporting/Analytics Experience job - Katalyst HealthCares & Life Sciences - Milwaukee, WI

January 8, 2018 - GCP Engineer, Reporting/Analytics Experience - p b RESPONSIBILITIES: /b /p ul li GCP Administration and configuration for automation /li li Create scripts/configurations /li li SME/Guidance
https://www.indeed.com/viewjob?t=gcp+engineer+reportinganalytics+experience&jk=b0ff699d4e146cdf&_ga=2.124904334.522784933.1515452185-251423520.1515107595

|| Drug Safety Specialist job - Katalyst HealthCares & Life Sciences ||

January 5, 2018 - Drug Safety Specialist - p b Overview: /b /p ul li The Drug Safety Specialist may be responsible for supporting a number of clinical and postmarketing safety activities,
https://www.indeed.com/viewjob?t=drug+safety+specialist&jk=dcc2d27cca979e89&_ga=2.150564787.466791019.1515288417-251423520.1515107595

Computer System Validation(CPT,OPT,H1B) Katalyst HLS

Responsibilities: Requires thorough understanding of System Development Life Cycles for FDA regulated applications Must be experienced in developing Computer System Validation deliverables for FDA-regulated applications: Validation Plans, Requirement Specifications, various levels of software testing scripts (IQ, OQ, PQ), Traceability Matrix, and Validation Reports. Requires thorough knowledge of US CFR 21 Part 11 regulations. Experienced with high volume application testing environment. Experience with automated Software Testing tools is a plus. Familiarity with QA Familiarity with a Corrective and Preventative Action (CAPA) program
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10750931&SearchString=&StatesString=&jobseq=12&rowsperpage=30&divisions=&divisions2=

Clinical Data Manager (CPT,OPT,H1B) Katalyst HLS

Responsibilities: Utilize extensive clinical data management experience on multiple assigned projects to accomplish team objectives. Meet assigned delivery dates with quality output for assigned tasks and tasks of other team members. Manage project deliverable and report progress to team members and management Employ risk identification and mitigation techniques and appropriate escalation as needed. Collaborate with cross function team members to ensure appropriate understanding of task. Deliver high level of quality in assigned tasks. Maintain project timelines and oversight of assigned tasks.
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10750902&SearchString=&StatesString=&jobseq=29&rowsperpage=30&divisions=&divisions2=

Process Validation Engineer(CPT,OPT,H1B) Katalyst HLS

Responsibilities: Validation Engineer responsible for validating/qualifying the systems used to develop and/or manufacture products within a large manufacturing facility. Ensure systems are running according to necessary specifications and operate within regulations to ensure data integrity and the production of quality products Schedules and executes validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines.
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10750903&SearchString=&StatesString=&jobseq=28&rowsperpage=30&divisions=&divisions2=

Clinical Data Manager (CPT,OPT,H1B) Katalyst HLS

Responsibilities: Utilize extensive clinical data management experience on multiple assigned projects to accomplish team objectives. Meet assigned delivery dates with quality output for assigned tasks and tasks of other team members. Manage project deliverable and report progress to team members and management Employ risk identification and mitigation techniques and appropriate escalation as needed. Collaborate with cross function team members to ensure appropriate understanding of task. Deliver high level of quality in assigned tasks. Maintain project timelines and oversight of assigned tasks.
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10750904&SearchString=&StatesString=&jobseq=27&rowsperpage=30&divisions=&divisions2=

Clinical SAS Programmer (CPT,OPT,H1B) Katalyst HLS

Job Overview: Writing SAS programs to create data sets, tables, figures, and listings reporting Utilizing SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH. Programming all aspects of a clinical trial, from files to tables and figures Using SAS in a quality control/ production capacity Write and edit programs to clean, manage, merge, and analyze data. Base SAS Certification and SAS advance certification is a plus. SAS clinical programmer with a minimum of 0-1 years of SAS clinical experience. CDISC, SDTM and ADaM.
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10750926&SearchString=&StatesString=&jobseq=17&rowsperpage=30&divisions=&divisions2=

Computer System Validation(CPT,OPT,H1B) Katalyst HLS

Responsibilities: Requires thorough understanding of System Development Life Cycles for FDA regulated applications Must be experienced in developing Computer System Validation deliverables for FDA-regulated applications: Validation Plans, Requirement Specifications, various levels of software testing scripts (IQ, OQ, PQ), Traceability Matrix, and Validation Reports. Requires thorough knowledge of US CFR 21 Part 11 regulations. Experienced with high volume application testing environment. Experience with automated Software Testing tools is a plus.
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10750928&SearchString=&StatesString=&jobseq=15&rowsperpage=30&divisions=&divisions2=

Regulatory Affairs Publisher(CPT,OPT,H1B) Katalyst HLS

Requirements: 4-5 years' experience in pharmaceutical area specifically related to Regulatory Affairs/Regulatory Operations Knowledge of the regulatory submission process Familiarity with the structure of global regulatory dossiers; experience with eCTD and eCopy submissions Experience with EDMS systems High attention to detail
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10750934&SearchString=&StatesString=&jobseq=9&rowsperpage=30&divisions=&divisions2=

Regulatory Affairs Publisher(CPT,OPT,H1B) Katalyst HLS

Requirements: 4-5 years' experience in pharmaceutical area specifically related to Regulatory Affairs/Regulatory Operations Knowledge of the regulatory submission process Familiarity with the structure of global regulatory dossiers; experience with eCTD and eCopy submissions Experience with EDMS systems High attention to detail
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10750935&SearchString=&StatesString=&jobseq=8&rowsperpage=30&divisions=&divisions2=

Quality Engineer (CPT,OPT,H1B) Katalyst HLS

Roles and Responsibilities: Ensure prompt escalation and complete documentation of product safety complaints by requesting feedback to regional units as needed Ensure complaint documentation and records are complete and in compliance with regulatory requirements prior to closure Provide complaint handling and quality engineering expertise and consultation to significant / complex projects. Escalate incomplete or overdue complaint investigation and resolution tasks to the management of the responsible task owner
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10750938&SearchString=&StatesString=&jobseq=5&rowsperpage=30&divisions=&divisions2=

Quality Engineer (CPT,OPT,H1B) Katalyst HLS

Roles and Responsibilities: Ensure prompt escalation and complete documentation of product safety complaints by requesting feedback to regional units as needed Ensure complaint documentation and records are complete and in compliance with regulatory requirements prior to closure Provide complaint handling and quality engineering expertise and consultation to significant / complex projects. Escalate incomplete or overdue complaint investigation and resolution tasks to the management of the responsible task owner Contribute to product safety, product quality, and customer satisfaction
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10750941&SearchString=&StatesString=&jobseq=4&rowsperpage=30&divisions=&divisions2=