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This position is responsible for leading internal and outsourced Clinical Data Management activities in support of Clinical Research studies, managing the definition of Case Report Form (CRF) requirements, creation of the Data Management Plan, coordination of Centralized Data Review activities (a key component of Risk-Based Monitoring), and is accountable for data integrity, quality, and consistency at Database Lock. The employee must be able to lead data review activities and engage different

- Irvine, CA

The candidate is responsible for expeditiously developing and processing raw material and product documentation to meet quality requirements within timelines established for product launch and/or timely project completion.The Master Specifications and Documentation department interacts with various Pharmaceutical groups within the organization and departments such as Quality, Global Pharmaceutical Technology, Regulatory Affairs, Operations, Manufacturing (all sites), Procurement (Sourcing),....


The specialist will work with a team of medical information professionals to capture unsolicited medical inquiries from health care professionals, consumers, and corporate business partners. Also, research and respond to requests for scientific/medical information using various search and retrieval techniques and medical literature database (product label, published and unpublished studies) to develop a medical/scientific response that is accurate, fair balanced, complete and delivered in a....


The Associate will be responsible for supporting CTM/OSL and ensuring that all assigned clinical study(ies) are running on time and on budget and are completed in compliance with all relevant laws, regulations, and regulatory guidelines as well as all policies and procedures. Requirements: Bachelor’s degree or higher (science degree preferably in science or health-related field) Previous experience of working on a clinical study 1-2 year relevant experience in pharmaceutical industry or CRO....


EDUCATION/EXPERIENCE: - 1+ years of relevant experience in pharmaceutical industry - Science degree in medical or health-related field - Clinical Trial Support/Clinical Study experience - Work effectively in a team/matrix environment - Handle conflict management and resolution RESPONSIBILITIES: - Ensuring that clinical studies are run on time and budget - Ensure compliance with regulatory guidelines - Management of clinical trial documentaiton - Tracking of various clinical trail resources


SENIOR RESEARCH INVESTIGATOR-Liver diseaseRare opportunity to transition from Academia for a specialist in liver disease research. You would work on interdisciplinary teams, where you will function independently in the execution of the experiments but will need to work collaboratively with other team members. Working independently, you will perform design, optimization and implementation of complex in vitro and in vivo experiments in rodents and NHP, and provide cross-organizational support....

- Philadelphia, PA

SENIOR RESEARCH INVESTIGATOR-TRANSLATIONAL RESEARCHRare opportunity to transition from Academia for a specialist in airway/pulmonary disease research. You would work on interdisciplinary teams, where you will function independently in the execution of the experiments but will need to work collaboratively with other team members. Working independently, you will perform design, optimization and implementation of complex in vitro and in vivo experiments in rodents and NHP, and provide....


POSITION SUMMARY: Independently responsible for the efficient and thorough investigation of process deviations and customer complaints, determination of root cause, and initiation of corrective/preventative actions designed to adequately address and correct the Quality related deficiencies identified during the investigation process. Responsible to provide proactive corrections based on noted trends to minimize the potential for repeat incidents that may lead to, or result in, the issuance of....


Summary We are currently accepting resumes for the position of Research Scientist in Analytical R and D/Methods Development and Validation. ResponsibilitiesMust be fully capable of developing analytical methods based on experience, literature search, etc.Design, develop, conduct and/or review experiments including method development and methodtransfer; perform methods validations utilizing typical instrumentation including but not limited to LC,MS, GC, etc.Interpret data from routine and....


Accountabilities and Responsibilities: - Engage and lead local IT team resources and business personnel to plan, implement, and support local as well as enterprise IT, laboratory, and business systems. - Be an integral member of multiple global IT and system teams, planning and implementing a global IT vision and infrastructure. - Exercise project management of local IT projects, including schedules, updates, meetings, documentation, resources, and completion milestones. - Proactively....


POSITION SUMMARY The Analytical Instrumentation Manager will be responsible for the management of daily activities in support of all analytical equipment in Quality Control. The manager will assure that activities associated with the testing, release and results reporting of materials, products and components meet established and expected quality, Data Integrity requirements, regulatory and customer requirements. The Manager will regularly interact with departments on site and at a corporate....


My CLIENT, is a New Jersey based, stable, not-for-profit biomedical research organization devoted to developing drugs that will slow the progression of neurodegenerative disease (NDD) and provide meaningful clinical benefit to patients. They are seeking a junior, but highly motivated and organized individual to assist their Science Directors managing projects in the clinical portfolio (including, but not limited to clinical studies and trials). They want a Bachelors or Master’s degree in life....


A leading manufacturer of pharmaceutical products is looking to fill an opening for a Sr. Packaging Development Engineer at their location near Buffalo, NY. The Sr. Packaging Development Engineer will be responsible for putting into operation advanced and complex principles of packaging technology. This position will require the implementation of technical packaging designs for drug products on large scope projects. They are looking for a Sr. Packaging Development Engineer who requires minimal

- London, United Kingdom

Our client, a Global Diagnostic Genomics Laboratory has a new opening for the Laboratory Quality Leader or Quality Engineer. The Quality Engineer provides effective leadership for activities necessary to ensure communication, training, competency assessment, and ongoing compliance monitoring with requirements under the laboratory’s quality management system (ISO 15189) CLIA and CAP). The Quality Engineer may designate certain selected duties and responsibilities to other laboratory staff,....

- Buffalo, NY

Our client is a global manufacturer of life-saving pharmaceutical products, seeking an Investigative Writer to join their Compliance Team in their Buffalo, NY site. The Investigative Writer will be responsible for the investigation of process deviations and customer complaints, conducting root cause analysis and identifying corrective/preventative actions to address and correct Quality deficiencies. The Investigative Writer take a proactive approach to identifying trends in order to minimize....


Our client, a global healthcare company, is searching for a Senior Manufacturing Automation Engineer to join their team in helping to produce products that help care for for critically and chronically ill patients. This Senior Manufacturing Automation Engineer position is located near Buffalo, New York. In this role, the Senior Manufacturing Automation Engineer will be responsible for oversight of manufacturing engineering projects. These projects will include: programming modifications of....

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