Company Description. Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices. We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners. Job Description. Responsibilities. Follow all compan...
Company Description. Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices. We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners. Job Description. Responsibilities. Responding to Ben...
Top Skills. Protein Mass-Spectrometry. Sample Preparation. Data collection. Biophysical and Biochemical Characterization. LC-MS. Job Description. Biologics Developability Screening and Automation. The Biologics CMC Developability team is an integral part of the Biologics CMC Drug Product Development organization at Client. The Biologics CMC Developability team is responsible for- (1) the identification of biophysical- and chemical liabilities in ...
Responsibilities. Actively participate on CMC development teams to plan regulatory strategies by defining pathways and milestones for submissions to support development activities leading to successful study authorizations and ultimately marketing approvals. Align CMC regulatory plans with cross-functional development and manufacturing teams. Execute regulatory strategies: track and manage progress within defined timelines. Articulate complex CMC...
Responsibilities. Involved in the programming activities on multiple projects/ studies across various therapeutic areas, both internally and externally by CROs. Creates and reviews annotated CRF to SDTM datasets. Provides support in balancing conflicting priorities, promoting communication and adequate information flow to motivate, encourage and align people with the company' s strategic objectives. Functions as a positive role model for setting ...
Job Description. Uses scientific education and analytical chemistry experience to perform simple to moderately complex laboratory testing within a good manufacturing practices laboratory to generate results. Interprets data output to determine conformance to specifications. Acts as a team member in the API/ Raw Material/ In-Process/Drug Product testing laboratories. Responsibilities. Independently performs and verifies a multitude of laboratory t...
Responsibilities. Supplier Engineer responsible for managing overall supplier manufacturing, operation issue across supplier base, ensuring process controls are established and ensure throughout the suppliers entire manufacturing process. Involve in Supplier Issue Resolution. Work on Corrective Actions Implementation, collaborate w/ cross functional team during issue resolution, Develop & Propose supplier Improvement Plan. Proliferate Key learnin...
Company Description. Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices. We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners. Job Description. Responsibilities. Customer case han...
Role And Responsibilities. Provide oversight to CRO clinical data management (CDM) activities for assigned studies. Review and provide feedback to CDM and study documents, including but not limited to the Data Management Plan, study protocols, data transfer agreements and data validation specifications. Responsible for assuring case report forms (CRFs) are designed and developed in accordance with study protocol and other supporting documentation...
Responsibilities. Preferred experience in the assessment and preparation of manufacturing sites for Pre-Approval inspections by Regulatory agencies for new products. Reporting to the Quality Assurance Organization, will independently manage project assignments. Must have strong demonstrated interpersonal, communication, negotiation, and persuasion skills. Must have very strong relationship building skills. Immediate project support on review and ...
Responsibilities. Develop, validate, and maintain statistical programs for data visualization and analysis using tools like Power BI, Python, R, or SAS. Collaborate with cross-functional teams to prepare and visualize data from clinical trials. Support statistical analyses and reporting of clinical study data. Clean, transform, and validate large datasets in compliance with regulatory standards. Assist in the development of reusable programming s...
Job Description. The Division of Enterprise Technology (DET) manages the state's information technology (IT) assets and uses technology to improve government efficiency and service delivery. DET administers enterprise solutions and consults on technology services for state agencies, local government and educational systems. Under the general direction of the Security Audit and Compliance Supervisor, this position provides assistance in the assess...
