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.
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.
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.
Black History Month – February, 2018
Know the past, shape the future @Katalyst HealthCare’s & Life Sciences
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.
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.
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
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.