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-Manages and is responsible for all aspects of assigned Phase I and extended Phase I/IIa complex clinical trials, within the approved Clinical Sciences Development Plan (CSDP).

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• Under general supervision, performs cGMP laboratory analyses of Finished products and in process materials. Cost of data recovery from hard drive Performs stability testing for Finished products.


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• Clean up and Prep work includes, but is not limited to, the following: washing, wrapping and sterilizing of glassware and laboratory equipment; loading/unloading autoclaves; washing ceilings, walls, floors, furnitu…

The candidate must be able to use or rapidly learn multiple automated business systems and processes, used in a manufacturing environment (SAP, TrackWise, Tracelink, etc.) as well as navigating regulatory type documents (…

– Responsibilities include creation of Master Packaging Records related to contract packaging. Snl database Will handle, manage and expedite change controls. Database 4500 Will handle and manage elec…

The primary focus of this team will be processing high quality PBMC samples from whole blood of patients on various clinical trials for downstream flow cytometry analysis. Data recovery miami fl The focus of this position is only on the production…

-Support study teams in administrative tasks and logistics (i.e. Data recovery sd card expenses, travel arrangements, meeting set-up including investigator meetings)

1. Uottawa database Lead cross-functional study team and/or sub-team, develop, manage and maintain study timelines, minutes, budget and tracking, develop training materials and coordinate training on study procedures, develop study management plan…

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-Receives, triages, and processes product identification calls, including speaking with the caller and documenting the request from the call into the Medical Information Database (IRMS).

-Support Regulatory Affairs CMC Director in managing and maintaining regulatory documentation for approved regulatory applications and licenses, and submission preparation (annual reports, supplements, variations).

Applicant should have experience conducting global regulatory assessments, submission authoring and assembly using CTD structure, and eCTD…

– Managing validation activities for commercial pharmaceutical packaging to ensure that all critical facilities, utilities, systems and processes remain in compliance with applicable regulatory requirements and in…

– Performing a variety of Material Handling duties, following standard operating procedures (SOPs) and ensuring the integrity of all necessary CGMP documentation in Receiving, Shipping and Warehouse.

Our pharmaceutical client is looking for a high-level Clinical Research Scientist with strong experience with reviewing and medical monitoring of Oncology study dat…

Package engineering group is looking for an engineer with background for the design, specification, and testing of secondary packaging for pharmaceutical products. Database query optimization The successful candidate will bring knowledge of package …

Support shakeflaks, small scale to large scale microbial and cell culture process development and deliveries. Qmobile data recovery Assist in preparing media and buffers, setting up, sterilization, sampling, and cleaning reactors along with pr…

• Seeking a strong candidate to perform routine analytical testing (using basic wet chemistry, HPLC, and GC) on in process, finished products, and other samples according…

This position is responsible for duties associated with cleaning validation processes and monitoring of cleaning verification activities consistent with cGMP requirements for clinical manufacturing, scale-up and commercial m…

Position is ½ clerical work and ½ very routine lab based work. No 1 data recovery software Clerical based duties would be filing of raw data printed records for long term storage and archiving and scanning of large documents and placing in a regulat…

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Will report directly to the Safety Coordinator and will be responsible for supporting a project, re-writing and updating SDS’s (Safety Data Sheets).

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• Under the direction of the Laboratory Group Leader/Supervisor perform testing per written instruction on a variety of routine and non-routine samples

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High School Degree and 5 years of process operations experience (with some pharma/biopharma) Degree in life science (AS BS), Biology, Chemistry, Biochemistry or other Experience preparing buffers/reagents (can be from school) Basic Mecha…

-Oversee the management of clinical trial databases from study start up to study closure at CRO (and or when required, support other DMs) by performing the following activities:

This position will manage and support small scale parenteral drug API and drug product development and manufacturing in accordance with FDA and GMP requirements

• Provides expertise in the operation and troubleshooting of hardware/software used in the laboratory cooperating with other departments, as required, to resolve problems that arise

Tests and interprets results for raw materials, active pharmaceutical ingredients, finished pharmaceutical products, and stability samples. Top 5 data recovery software Interprets compendial and internal monographs, NDAs and Laboratory Quality Standa…

• Perform hands on analytical testing for method development, validation or transfer as well as routine stability testing in a QC environment as needed.

Under the direction of GMPQ supervision, the Auditor conducts routine audits of data, information, procedures, equipment and systems (including computer systems), and/or facilities to ensure the compliance with Standard O…

• Assists and supports the organization with initial compliance and ongoing preparation and monitoring to established quality assurance processes and standards for manufacturing, quality control and research and deve…

Statistics experience or experience working with biopharma or clinical data Experience with SampleManager LIMS, preferred Experience with JMP (SAS Software) or other statistical programs Excel and/or…

• Isolation, identification and susceptibility testing of organisms from wounds, blood cultures, sterile body fluids, respiratory, stool and urine sources

– Hold full responsibility for the timely delivery of projects through successful coordination of all tasks associated with packaging, labelling, and distribution

-Supports the Sr. Data recovery mac CTM/operational study lead in collaborating with clinical affairs and other functions, and responsible for, the execution and delivery of studies (e.g. Database website Clinical Planning, Regulatory Affairs, Global Drug Safety, P…

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-Develops and ensures proactive business partnering relationships with internal stakeholders to understand their strategic business and procurement requirements and work toward successful achievement of those requirements.

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-Manage monthly forecast update process from statistical modeling through consensus for assigned brands by leading Marketing and CDP to derive the consensus forecast.

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1. Database primary key Develops primary and secondary packaging structures in support of broader project directives. Database link oracle Is responsible for creating all component specifications and finished good Bills of Materials (BOMs) in the Product Lifecycle Change M…

-Develop, evaluate, and implement business critical retrieval and analysis technologies (text, data mining and visualization) with focus on pharmacology, biomedical, technical and business/competitor information

• Perform standard quality control testing on incoming raw materials, semi-finished goods, and finished goods according to defined specifications

– Independently performs QC on clinical components of assigned documents (eg, clinical study reports, investigator brochures, manuscripts, summary documents, regulatory responses, etc.). 7 data recovery key Formally documents findings of assigned documents…

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