Oracle Argus Projects Consultant job - Katalyst HealthCares & Life Sciences

Oracle Argus Projects Consultant - Job Description: Manages and Coordinates the qualification and deployment of Adverse Events Reporting Systems (Oracle Argus). Solid technical background and experience related to Argus Safety, Argus Insight, Analytics. BIP / OBIEE reporting. E2B. Oracle SQL and PL/SQL.
https://www.indeed.com/viewjob?t=oracle+argus+projects+consultant&jk=d81acab3e3e353ab&_ga=2.127832526.2136219104.1519593558-833183749.1502106191

Regulatory Affairs Associate katalyst HLS

Responsibilities: Compile/review IND and NDA documents in e-CTD format Submit regulatory documents to the US FDA Help review the regulatory strategy for the group Keep up to date with current FDA regulations
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Regulatory Publishing consultant Katalyst HLS

Responsibilities: Use your Regulatory Submissions expertise to work with United States and International Regulatory submissions. Create FDA and ICH compliant regulatory submissions. These submissions are complex and are intricately linked into a cohesive product that can be easily reviewed by a regulatory agency Perform detailed quality reviews of published output to ensure compliance with Regulatory Standards and FDA guidances. This includes verification of bookmarks, hypertext links and tables of content in global submissions. Expedite, manage and coordinate a multitude of concurrent interrelated activities for Global Project Teams and/or multiple products in the development of published Global submissions within the required timeliness Prepare Investigative New Drug (IND) safety cover letters and IND amendment submissions to FDA.Requirements-
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Regulatory consultant Katalyst HLS

Responsibilities: Use your Regulatory Submissions expertise to work with United States and International Regulatory submissions. Create FDA and ICH compliant regulatory submissions. These submissions are complex and are intricately linked into a cohesive product that can be easily reviewed by a regulatory agency Perform detailed quality reviews of published output to ensure compliance with Regulatory Standards and FDA guidances. This includes verification of bookmarks, hypertext links and tables of content in global submissions. Expedite, manage and coordinate a multitude of concurrent interrelated activities for Global Project Teams and/or multiple products in the development of published Global submissions within the required timeliness Prepare Investigative New Drug (IND) safety cover letters and IND amendment submissions to FDA.Requirements-
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Regulatory submission consultant Katalyst HLS

Responsibilities: Use your Regulatory Submissions expertise to work with United States and International Regulatory submissions. Create FDA and ICH compliant regulatory submissions. These submissions are complex and are intricately linked into a cohesive product that can be easily reviewed by a regulatory agency Perform detailed quality reviews of published output to ensure compliance with Regulatory Standards and FDA guidances. This includes verification of bookmarks, hypertext links and tables of content in global submissions. Expedite, manage and coordinate a multitude of concurrent interrelated activities for Global Project Teams and/or multiple products in the development of published Global submissions within the required timeliness Prepare Investigative New Drug (IND) safety cover letters and IND amendment submissions to FDA.Requirements-
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Regulatory affairs consultant Katalyst HLS

Responsibilities: Use your Regulatory Submissions expertise to work with United States and International Regulatory submissions. Create FDA and ICH compliant regulatory submissions. These submissions are complex and are intricately linked into a cohesive product that can be easily reviewed by a regulatory agency Perform detailed quality reviews of published output to ensure compliance with Regulatory Standards and FDA guidances. This includes verification of bookmarks, hypertext links and tables of content in global submissions. Expedite, manage and coordinate a multitude of concurrent interrelated activities for Global Project Teams and/or multiple products in the development of published Global submissions within the required timeliness Prepare Investigative New Drug (IND) safety cover letters and IND amendment submissions to FDA.Requirements-
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Regulatory Affairs Associate Katalyst HLS

Responsibilities: Use your Regulatory Submissions expertise to work with United States and International Regulatory submissions. Create FDA and ICH compliant regulatory submissions. These submissions are complex and are intricately linked into a cohesive product that can be easily reviewed by a regulatory agency Perform detailed quality reviews of published output to ensure compliance with Regulatory Standards and FDA guidances. This includes verification of bookmarks, hypertext links and tables of content in global submissions. Expedite, manage and coordinate a multitude of concurrent interrelated activities for Global Project Teams and/or multiple products in the development of published Global submissions within the required timeliness Prepare Investigative New Drug (IND) safety cover letters and IND amendment submissions to FDA.Requirements
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Regulatory Submission Specialist Katalyst HLS

Job Description: The detail-oriented Submission Specialist is responsible for all paper and electronic publishing activities for regulatory submissions to global health authorities following FDA and ICH guidance Job Responsibilities: Participate in draft and final document reviews with a focus on managing quality control of document preparation of Word and PDF documents to health authorities Proofread, review and edit Word documents for grammar, accuracy, and consistency Prepare submission ready documents that includes bookmarking and hyperlinking Overall operational planning, coordination and support of compliant submission dossier publishing activities with the ability to manage publishing timelines for the compilation of submission and maintenance of regulatory filings Coordinate document deliverables and submission timelines with publishing vendor Plan, prepare and publish submission documents (IND's, CTAs, Amendments, DSURs, IMPDs, SUSARS, etc.) for both electronic and pap
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| Validation Lead - Katalyst HealthCares & Life Sciences, MA |

February 13, 2018 - Validation Lead - Job Description: Validation/SDLC lead provides guidance to business and project teams in Software Development Life Cycle (SDLC)/Computer System Validation (CSV)/Lab Systems/Lab Equipment/Infrastructure Qualification standards and practices.
https://www.indeed.com/viewjob?t=validation+lead&jk=cccbdd3d99d6a7eb&_ga=2.228725340.1993267931.1518841385-251423520.1515107595

Regulatory Affairs Contractor - Katalyst HealthCares & Life Sciences, NJ |

February 9, 2018 - Regulatory Affairs Contractor - Responsibilities: Prepare and submit product, manufacturing, packaging, or labeling/IFU changes to European Notified Body, as required through Significant Change Supplements or Notifications. Prepare 510(k)'s to FDA pertaining to device changes requiring FDA clearance, as required and as determined by regulatory strategy. Submit notifications to Regulatory Affiliates pertaining to changes to product, manufacturing, packaging, labeling, etc.
https://www.indeed.com/viewjob?t=regulatory+affairs+contractor&jk=f92c04128c455795&_ga=2.228725340.1993267931.1518841385-251423520.1515107595

Manager, Biostatistician job - Katalyst HealthCares & Life Sciences, NJ |

February 9, 2018 - Manager, Biostatistician - Job description: Work with the clinical study team on study design, development and/or review of clinical study protocols. Contribute to clinical trial design, protocol concept sheet and protocol development. Participate study related activities and provide statistical support such as reviewing Case Report Form (CRF) and guidance, validating randomization scheme and developing Study Quality Surveillance Plan (SQS), reviewing Independent Radiology Review Committee Charter and data transfer plan, etc.
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Packaging Development Scientist Katalyst HLS

Department/Team Description: Individual will work in the Packaging Development Group. The group is responsible for all packaging development related issues. Change control management, plant support as well as support of corporate initiatives are its primary function. Position Summary: The individual is responsible for issues associated with the packaging of solid, liquid, cream and ointment OTC and nutritional products manufactured at the Myerstown, PA location. Responsibilities include, but are not limited to, package development, design and testing; identifying meaningful component specifications; qualifying components and packaging operations; troubleshooting commercial packaging operations; and implementation of quality and cost improvement programs. Also, work within established guidelines to implement new packaging projects that have been initiated by the Marketing/I&D/Product Supply Departments in Morristown.
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Regulatory Labeling Lead Katalyst HLS

Responsibilities: In support of these activities, the Provider will adhere to Client established timelines as indicated in SOPs, implementation guidelines, job aids, guidance documents, regulatory requirements, training materials and other related communications provided by Client. Reinforce labeling strategy by guiding and advising the Labeling Team on internal labeling guidance and policies and will raise awareness of important factors to consider when revising the label. Remain up-to-date with labeling guidelines and regulations as they pertain to the development/maintenance of US and EU labeling and advise the Labeling Team on the application of these labeling principles. Be knowledgeable on key labeling requirements worldwide. Ensure that downstream impact on CLDs is considered during Labeling Team discussions. Advise the Labeling Team on the content of other labels in the same therapeutic class, including competitor labeling, to help guide the team in developing labeling te
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Labeling Manager – LRC Coordinator Katalyst HLS

Job Description: The purpose of this highly visible role is for a labeling professional to lead a labeling management committee meeting (Labeling Review Committee-LRC). The manger will ensure that the LRC is scheduled weekly, or as necessary, with enough time alloted per topic. Management will include outcome documentation and distribution, LRC member approval collection, storage of documented outcomes, ensuring that outcomes are documented in the appropriate repository, other actions necessary for coordination and follow-up. This position will also include labeling advice provided to Labeling Managers, process improvement, patient glossary update, and device labeling.
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Clinical Trials Label Coordinator Katalyst HlS

Job Description: Develop an understanding of the clinical supply chain organization and its processes. Interacts with global external vendors and cross functional support teams. Responsible for completing specific tasks for assigned projects and studies. May work on projects with peers from other departments or functions. Ability to deliver under minimal supervision of projects with varying complexity. Collation and archive approvals from different stakeholders and update the label text library database accordingly. Executes to a pre-established timeline and project plan and is responsible for completion of specific milestones. Mitigate issues and concerns to the label requestor. Reviews GMP documentation for operational and technical accuracy. Works with team members and supervisor to identify and resolve problems. Develops internal cross-functional and external relationships. Manages issues and fosters teamwork. Participates on cross-functional teams as necessary. Coordi
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Senior Regulatory Submission Specialist Katalyst HLS

Department/Team Description: Individual will work in the Packaging Development Group. The group is responsible for all packaging development related issues. Change control management, plant support as well as support of corporate initiatives are its primary function. Position Summary: The individual is responsible for issues associated with the packaging of solid, liquid, cream and ointment OTC and nutritional products manufactured at the Myerstown, PA location. Responsibilities include, but are not limited to, package development, design and testing; identifying meaningful component specifications; qualifying components and packaging operations; troubleshooting commercial packaging operations; and implementation of quality and cost improvement programs. Also, work within established guidelines to implement new packaging projects that have been initiated by the Marketing/I&D/Product Supply Departments in Morristown.
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World Cancer Day 2018 – Katalyst HealthCares & Life Sciences

World Cancer Day 2018: 'We can. I can.' Katalyst HealthCare's & Life Sciences   The theme of World Cancer Day, explores how everyone – together and individually – can do their part to reduce the global burden of cancer.   American Cancer Society World Health Organization (WHO) U.S. Food and Drug Administration National Institutes of…
https://katalysthls.wordpress.com/2018/02/04/world-cancer-day-2018-katalyst-hls

Learn everything about careers at Katalyst HealthCares & Life Sciences Inc.

Find your next great career opportunity at Katalyst HealthCares & Life Sciences Inc. Search for job openings today.
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Medical Device Regulatory Consulting Services - Katalyst HLS

Medical Device Regulatory Services: Pre-market approval - PMA. Pre-market notification - PMN 510(k) Investigational Device Exemption - IDE (for clinical studies) Combination product (Drug/Device) Submissions Establishment Registration and Device listing Patent Registration Strategy and Regulatory Agency meetings.
http://katalysthls.com/regulatory-affairs/