- UpvoteDownvoteShare Job
- Suggest Revision
Familiarity with genomics assay qualification/validation guidelines and guidance (FDA, CAP, CLIA, ACMG, NYSDOH, global regulatory requirements for assay development). This includes but is not limited to responsibility for genomics and gene expression profiling (GEP) biomarker assay technology/ platform selection, evaluation of in-house or vendor choice per assay use requirements, development, optimization, qualification/validation and/or execution of biomarker analysis for BMS translational medicine and clinical programs.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Applies specialized Epic Tapestry knowledge to improve processes and support strategies, assists junior personnel, and is responsible for ongoing assessment, design, validation, development, and implementation of the Epic system.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
The main activities would include review of the Protocols, eCRF, SDTM/ADAM specs review, SAP authoring, DB lock support topline results validation/interpretation, CSR co-authoring and eventual regulatory strategy development and submission.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Create and modify validation documentation including but not limited to: User Requirements Specifications (URS) Design Reviews (DR) Criticality assessments CSV protocols (SAT, IQ, OQ, PQ) which verify if the system is compliant to regulatory and client requirements Reports which summarize the results of the protocol executions.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Expertise, in-depth hands-on experience is expected in genomics platforms (NGS, qPCR, variant analysis platforms) for assay development, qualification/validation, troubleshooting, and reviewing run QC data.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Expertise and demonstrated ability to develop assays, oversee assay validation inhouse or with external vendors, develop appropriate controls/ QC methodology, oversee clinical sample analysis and assay performance and help develop and deliver program genomics biomarker strategic plans.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Enterprise Model Risk Management seeks a Senior Quantitative Finance Analyst – Liquidity Risk to conduct independent testing and review of complex models used to monitor and mitigate liquidity and funding risks in the Bank. Responsible for compliance with Enhanced Prudential Standards and other regulatory guidelines, the candidate will work on models related to both banking and trading businesses of Bank of America.
Full-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Genmab is looking for an additional System Compliance Manager for our enterprise electronic document management system (EDMS) – GenDocs, covering the clinical development, regulatory affairs, CMC, and QA areas in R&D.
Full-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Profound grasp of Machine Learning lifecycle - feature engineering, training, validation, scaling, deployment, scoring, monitoring, and feedback loop. Key matrixed partners included: Brand Marketing, Creative / CRM / Digital agencies, Media, Market Research, Analytics, Otsuka Information Technology (OIT), Sales Operations, and Medical/Regulatory/Legal integrated business partners.
Full-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Experience with GMP manufacturing, technology transfers, process validation, cell & gene therapy processes, automated bioreactors, regulatory inspections. Manage execution of technology transfer activities by the team at the decentralized point-of-care manufacturing sites, including equipment qualification, production training, aseptic process validation, process qualification runs, operational readiness.
Full-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Perform Medical Dictionary for Regulatory Activities (MedDRA) and/or World Health Organization Drug Dictionary (WHO-DD) medical coding procedures · Participate in conference calls and/or meetings with vendors and sponsors.
$120,000 a yearFull-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
- Suggest Revision
Provide statistical/programming support for responses to regulatory authorities related to submission reviews. This position reports to the local area Lead within Biostatistics and Data Management (BDM) group at SPARC. The main responsibilities will include hands on day to day support of one or more clinical studies.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
- Suggest Revision
Knowledge of and experience with CDISC standards and validation processes required. The Director, Biostatistics & Data Analytics will provide statistical and programming expertise to the development of clinical study designs and in performing data analysis, providing data interpretation and graphical/summary outputs, and contributing to clinical publications and regulatory submissions.
Full-timeExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Create and modify validation documentation including but not limited to: User Requirements Specifications (URS) Design Reviews (DR) Criticality assessments CSV protocols (SAT, IQ, OQ, PQ) which verify if the system is compliant to regulatory and client requirements Reports which summarize the results of the protocol executions Exception reports which identify defects or issues during test execution Review vendor documentation.
Full-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
- Suggest Revision
In this critical position, the Validation Specialist is responsible for authoring and executing installation, operation and performance process and equipment qualifications (IOPQ)for the site to ensure compliance with local and global regulatory agency requirements, internal company standards and current industry practices.
Full-timeExpandApply NowActive JobUpdated 1 month ago
validation regulatory jobs in Princeton, NJ
FEATURED BLOG POSTS
Making Hybrid Work More Efficient
Covid was a catalyst for change in the work environment. Keeping people safe and helathy was the initial goal for employers, but the unintended result was the considerable demand in remote work. Now, onsite work has been dramatically altered to remote work, which is now transforming into a combination of the two: hybrid work.
How Can HR Technology Help Retain Employees?
Human resources' rapid adoption of technology has led to new ways of streamlining human capital management. Based on the IEE Global Study, these technologies changed how HR handled recruitment and retention in 2022. This includes tech like
Why is Time Management Important? 10 Crucial Importances of Time Management
We’ve all been there before. What starts as a relaxing evening scroll quickly becomes a full-blown binge. You blink, and it’s midnight - throwing off your entire next day before it even starts. And at its worst, this indulgence might leave you feeling behind on things you planned to finish that night. This is why time management is important.
Minimizing Candidate Renegs During the Hiring and Onboarding Process
Candidates reneging on job offers or during the onboarding process can be a frustrating experience for any recruiter. In a talent-driven job market, it’s common for candidates to have more than one job offer to consider. It becomes a race against time to see which organization can offer the best career experience, compensation, and circumstances that secure the right employees.
10 Reasons to Be on Time at Work
Being punctual at work may not be something you’ve given much thought to, but it’s the foundation for building a successful career. All of your technical or job-specific skills will be in vain if your peers and superiors can’t trust you to show up on time and do the work. In fact, Simon Sinek once famously said that
10 Importancies of Setting Realistic Goals
We’ve all heard how important it is to set professional and personal goals. Developing and establishing goals keeps us motivated and moving forward in life. But not all goals are created equal. If you’re chasing goals that are too lofty, you’ll end up disappointed when you cannot reach them. Setting goals that are achievable and measurable is the key to success.
Email Etiquette Principles - Why is it Important
Why is email etiquette important? Let's imagine you're hiring for a new role, and you’ve just received the email below.