Job Description Skills/Knowledge Required: BS/BA degree or equivalent in a relevant scientific discipline with a minimum of five years’ experience Advanced knowledge of clinical database design is a must (RAVE, InForm, Oracle Clinical) Demonstrated proficiency in creating standard operational metadata, and CDASH compliant CRFs In-depth understanding of CDASH and SDTM requirements Good communication skills; ability to work in a team environment with data managers, medical personnel, clinical monitors, statisticians, programmers,...
Job Description Responsibilities: This position will assist with the preparation and submission of ANDAs, Amendments, Supplements, and Annual Reports to appropriate regulatory agencies. This position will also provide support of the regulatory function through document management, electronic submission compilation and management, and other group management activities as required. Works with Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Research and Development groups, Information Technology, and other departments as needed. May submit...
Responsibilities: This CSV Lead will be working with the application configurators to document the processes and workflow. Identifying risks-based approach to their validation process; future enhancements, upgrades, workflow mods, etc. This will be a cloud-based system. PQ will be the focus for the validation process and policies. Someone coming out of small to mid-size co is ideal for this role. Familiarity with IDOL IT concept (systems governed across a number...
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 Job Description: Summary: Under limited supervision, performs the preparation, review and submission of pre and post-approval submissions to...
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 Position Summary: Life-sciences focused Systems Engineer to provide support of general IT Infrastructure escalations and technical expertise in...
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 The Regulatory Project Manager (RPM) is a regulatory specialist with project management capabilities responsible for leading the end-to-end...
Job Description Job Description: The Client Devens, MA Project Management Office is seeking to fill a project management support position for a 6 month contract. The successful candidate will provide significant contributions toward delivering technical projects across the 350 person site. The successful candidate will have a demonstrated background in bioprocessing (upstream and/or downstream) and strong communication skills (status, issues, information for awareness). Responsibilities: Work independently and with project leaders...
Job Description Responsibilities: Review and correct all Control Plans according to part drawing specifications and characteristics, as well as the Machining PFMEA’s. Involved in the review and updates of PFMEA’s, requiring control plan updates as necessary. Requirements: Experience in casting and/or foundry (Mandatory). A Bachelor's degree is required. Must be a degreed Engineer from an accredited College in Mechanical, Industrial, Manufacturing, or related engineering field. Familiarity with machining processes is...
Job Description Responsibilities: The clinical data review individual will work as a key member of the data review team. This individual will work independently with guidance in only the most complex situations and serve as a close partner to the physician and clinical scientist on the team. This position will have key relationships internally with clinical project teams, operations and data management, as well as with other members of the...
Responsibilities: Basic knowledge of aseptic manufacturing environmental monitoring of Grade A-D Areas. Validation protocol writing, review, and execution (or overseeing validation execution). SOP review, creation, and approval. OOS investigations writing/review and approval. Mentor junior Analysts on testing, troubleshooting, and lab-related items. Ensure compliance with all cGMP standards, safety and environmental regulations, and company SOPs. Provide advice to subordinates based on general policies and management guidance. Ensure that high-level projects are...
Responsibilities: Responsible for supporting the Programming deliveries of a clinical study or project. Implements statistical programming aspects of the protocol and the clinical development program Ensures high quality is built into own deliverables and the quality delivered by other programmers Programs independently with high efficiency and quality Writes and/or implements specifications and oversees completeness of relevant documentation Contribute to the development of best practice to improve quality, efficiency and effectiveness...
Responsibilities: Supporting and validating regulatory systems like REMS and RIMS. Computer system validation of regulatory systems such as Regulatory Information Management System, REMS, publishing, and eCTD systems used in the pharmaceutical industry. Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC application of FDA guidance and industry standards (i.e., GAMP). Strong understanding of 21 CFR Part...
Responsibilities: Act as Lead Data Manager, overseeing all deliverables of activities outsourced to DM CRO for multiple studies. Interact and manage relationships with other functional areas to ensure high quality data management activities. Oversight of data collection tools (EDC, DTAs, EDC integrations) and essential documents (DMP, UAT Documents, data edit specifications, annotated case books and data entry guidelines). Participate in User Acceptance Testing Activities for the applicable Data Collection Tools....
Job Description Responsibilities of the Medical Monitor: Providing Medical Leadership to the monitoring staff in the region Developing and maintaining expertise in the compounds under development and their related fields Monitoring the safety of subjects participating in the Clinical Trials Selection of Clinical Investigators Handling Serious Adverse Event Reports in accordance with the SOPs Ensuring timely distribution of IND reports to investigators and EC Review and agreement of study budgets...
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 Job Description: Responsible for the development of Summary Technical Documentation (STED) for CE marking to integrate varied technical...
Responsibilities: Provide hands-on Statistical Programming expertise for client's early phase translation medicine group. Responsible for creating ADaM safety datasets such as ADSL, ADLB, ADVS, ADEX, ADPC (concentration), ADPP (parameter), and POPPK (NONMEM) datasets, PK non-compartmental (NCA) tables, figures, and listings (TFLs). Experience with Phase I studies, exposure response analysis, cross over design, and supported pooling of PK parameters required. Strong SAS technical skills and in-depth CDISC knowledge. Good knowledge regulatory...
Roles&Responsibilities: Independently plan, execute, analyze, and interpret in vitro and in vivo immunological assays that support the initiation and/or advancement of drug candidate projects. Proactively evaluate new technologies and develop new assays to accelerate early-stage discovery activities and/or enhance our understanding of disease mechanisms. Manage multiple projects simultaneously and work cross-functionally with colleagues in the oncology, protein engineering, chemistry, translational medicine, biomarker and clinical groups. Present research findings and recommendations...
Job Description ESSENTIAL FUNCTIONS: Responsible for the laboratory testing in accordance with company SOP's as well as cGMP's and GLP's. Testing involves raw materials, in-process, finished product, and stability samples for potency and physical characteristics such as pH, specific gravity, moisture, etc. Maintains lab work area in a neat and ordered fashion. Proficient with the operation of instrumentation such as HPLC, UV, GC, KF, AA, FTIR. Works in support of...
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 Company Description: Katalyst Healthcares&Life Sciences Inc. is hiring entry level candidates for several positions for contract research in...
Job Description Job Description: Project Coordination for Legal Entity Integration Works – EMEA / APAC / LATAM – as required Ensure integration activities are on track. Reach out to other departments/groups to assist with blocks/issues. Liaise with local PMs as required. Reporting to manager in terms of day to day activities / highlighting issues / completing dashboards as required for project. Scheduling meetings with regional leads for QA item reviews...
Responsibilities: Develop strategies for worldwide product registration with global regulatory agencies. Provide regulatory advice, preparing worldwide submissions, negotiating approvals, and assisting with license maintenance, including renewals and manufacturing site registrations. Author and prepare regulatory submissions for new products and changes. Review significant regulatory issues with supervisors and resolve submission issues. Develop regulatory strategies and provide ongoing support to project teams. Maintain regulatory support for marketed products and prepare necessary submissions....
Job Description Responsibilities: Strong knowledge of pharmaceutical/medical device regulations like GxP, FDA 21 CFR Part 11, 210, 211. Working experience in a regulated Pharmaceutical industry in the areas of Research/Lab areas. Strong expertise on lab system validation process including instrument commissioning/decommissioning, calibration, new lab set up, etc. Requirements: Having experience writing Validation work products: Master Plans, Risk Assessments, Installation Qualification Protocols, Operational Qualification Protocols, Performance Qualification protocols. Experience in performing...
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 Job Summary: We are a reagent manufacturing site looking for an Applied Statistician with industry experience. The candidate...
Responsibilities: Directs and coordinates tasks, and teams, to ensure the project meets the demands of the client. Direct internal project scope of work, budget, timeline, and change orders. Responsible for materials planning, budget development and cost control for assigned projects. Direct and obtain the equipment and resources needed on the project(s). Develop and maintain a detailed project schedule and work plan. Understand Lifecycle management for Quality Applications, processes for protocol...
Responsibilities : Serve as lead CDM on assigned clinical trials by attending internal and external clinical trial project team meetings. Responsible for the study-specific data management tasks from protocol review to database lock to ensure data are collected , reviewed, and delivered with high quality, on-time, and within scope. Responsible for the accurate development of CRFs and edit specification per protocol and the completeness of user acceptance testing of CRFs...
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 We are looking for Quality Assurance Specialist for one of our clients in M D . Kindly go...
Job Description Job Summary/Scope: The Sr. Clinical Trial Manager provides strategic and operational leadership of clinical research studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs/WPs. Responsibilities may include operational direction of one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams. Responsibilities: Responsibilities involve a combination...
Responsibilities Ensure the lab instruments are calibrated prior to performing IQ/OQ and certify. Produce GxP documentations for the instrument software validation. Own change controls and deviation management. Prepare and execute IQ/OQ protocols for lab instruments. Prepare validation plan and summary reports. Collaborate with business team for completion of GxP activities as per project plan. What are the top skills required for this role? Life Sciences Domain knowledge Computer System Validation...
Job Description Job Description: Provide statistical support including statistical design and data analysis of clinical trials, and perform secondary data analysis to support opt trials&publications. Proficiency in SAS programming. Masters or higher degree in statistics is required. At least 2-3 years of experience in pharma required. Additional Information All your information will be kept confidential according to EEO guidelines. J-18808-Ljbffr
Job Description Description: The Quality Engineer is responsible for maintaining a good vendor/customers relationship by consistently exceeding customer specifications, throughout proper product development and supply in a world-class condition. All systems/criteria shall be developed, documented, and maintained to ensure consistent quality assurance. Essential Duties and Responsibilities: Maintains adherence to product quality standard in department for incoming materials and finished goods Identifies and records any problems relating to product, process, and...
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