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Position/Location	Mini Description (37 Job Postings)
Scientific Research RAYNHAM, MA	• Primary duties will involve working with a small team to develop and execute analytical chemistry methods supporting scale-up and characterization of a process for deposition of calcium phosphate coatings on orthopedic implants. • Follow laboratory procedures and safety guidelines, maintain detailed laboratory notebooks, and prepare technical reports as needed. • The successful candidate will have a solid background in chemistry and experience working on process development within an R&D...
Scientific Research Somerville, NJ	· Work with Sr. Leadership on the management of the product lines and suppliers to include product changes, additions, and deletion. · Work with an international supplier base on documentation to support both an internal and FDA compliant quality system and product registrations. · Serve as Lead or Project Manager for the entire product line to ensure all documents are complete, accurate, and well maintained. · Assure all records and device inspections are con...
Scientific Research Skillman, NJ	· Laboratory Scientist with primary responsibility for a clinical study collecting facial skin bacterial samples from human subjects, processing samples in Microbiology laboratory, evaluating microbial results, performing data calculations and entry with MS Excel. · Clinical Study requires shifted work day hours (11AM – 7:30PM) one week per month · Secondary focus of this role involves research studies utilizing standard and modified methods such as microbial kill time, ...
Scientific Research San Francisco, CA	· Develop, validate, and perform ELISAs and ECLAs under GLP/GMP for pre-clinical and clinical studies of biological products. · Perform PK, Immunogenicity, and Biomarker GLP bioassays for drug development clinical sample testing. · Maintain cell cultures, laboratory reagents, supplies, and equipment suitably for GMP/GLP operations. · Generate and analyze laboratory results. · Review and report data. · Participate in maintenance of inventory...
Scientific Research Cranbury, NJ	· Perform routine, method validation and research experiments with moderate supervision. · Following sample analysis, the Associate Research Scientist is responsible for calculation, processing, review, and compilation of the results. · Should be able and desire to learn new technology. · Perform a variety of routine and some complex laboratory procedures utilizing appropriate analytical instrument in support of new and improved product development. · ...
Scientific Research Wilson, NC	• Assist, support, and execute the day-to-day GxP Training functions and in the daily administration of the SAP LSO training system. • Support, and data entry experience, basic SAP knowledge, to provide support to the team and help with the logistics of the training program. • Review the Individual and Group training files for completeness and accuracy • Maintain training files on a weekly basis • Assist in the Annual Curricula Review process and associated curricula updates • Perform tr...
Scientific Research Los Angeles, CA	· Process validation of new and currently marketed cosmetic, personal care and OTC Monograph drug products. · Knowledge of the principles and approaches of product related process validation and will be responsible for providing hands on technical support to the Validation Manager in the design, development, and the implementation of validation studies meeting FDA requirements for products . · Program scope includes Semisolid (creams, gel and lotions) and Liquid products...
Scientific Research Jacksonville, FL	· Plan and monitor human clinical trials in compliance with internal procedures, ICH Guidelines, Good Clinical Practices (GCP) and applicable Regulations and Guidelines. · Coordinates protocol and case report for development and compilation. · Insure appropriate clinical trial agreements are signed and materials are distributed. · Monitors and secures protocol and regulation compliance at investigational sites. · Reviews, retrieves, and reports the t...
Scientific Research Raynham, MA	· Responsible for drafting, implementing, monitoring, and evaluating compliance with contractual requirements for all clinical investigations. · Acts as the contract liaison between Codman and the investigation site or vendor, answering any questions related to the contract, resolving issues as appropriate, and working with the attorney and internal clients as necessary. · Track and oversee clinical investigator contract status. · Audit and evaluate all clinica...
Scientific Research Sommerville, NJ	· Works closely and assures adequate regulatory support to R&D and asset reconfiguration teams. · Prepares and manages regulatory submissions (US/EU). Submissions include 510k, PMA supplements and IDE’s. 510k, PMA supplement experience is a mandatory for this position. · Conducts critical reviews of key technical documents (aiming to ensure completeness, scientific accuracy, regulatory compliance, consistency with other key documents, and ease of review). · D...
Scientific Research Jacksonville, FL	• Plan and monitor human clinical trials in compliance with internal procedures, ICH Guidelines, Good Clinical Practices (GCP) and applicable Regulations and Guidelines. • Coordinates protocol and case report form development and compilation. • Insures appropriate clinical trial agreements are signed and materials are distributed. • Monitors and secures protocol and regulation compliance at investigational sites. • Reviews, retrieves, and reports the trial data as the requirements dictat...
Scientific Research New Brunswick, NJ	· The Scientific & Clinical Affairs (SCA) group consults with all of the MD&D Franchises to help demonstrate Clinical Effectiveness, Value Proposition and Safety of our products and services. · Healthcare Informatics team within the SCA group undertakes observational research to support development, launch and post-marketing assessment of MD&D products. · The team provides analytical services using large administrative, patient-level databases to answer a variety of que...
Scientific Research LOS ANGELES, CA	· Working in the Clinical Supply Department with many functional groups to prepare investigational products and/or marketed products for preclinical, clinical, efficacy, consumer and market research studies. · Support programs in the Cosmetic and OTC businesses and for preparing the study supplies within GMP guidelines in accordance to the project timelines. · Training on and adherence to department SOPs is required. · Work closely with the Clinical Supplies A...
Scientific Research San Francisco, CA	· Processes adverse event information received by the GPRM department for assigned products, and assists in the preparation of internal and external reports. · Triages incoming cases to determine seriousness for processing and reporting prioritization · Reviews case information for appropriate distribution to internal and external business partners · Performs accurate computer data entry of identified AE information and ensures the uniform and timely processin...
Scientific Research San Francisco, CA	Clinical Trial Auditor • Review and assess company activities to assure that contractual obligations to client companies are met, and that monitored clinical trials are conducted in compliance with federal regulations, International Conference for Harmonization (ICH) and Manufacturing Practices (GMP) guidelines, company SOPs and any other relevant state or local regulations • Conduct and document GMP audits of investigator sites to verify that clinical trials are conducted in compliance with...
Scientific Research SPRING HOUSE, PA	• Performing cellular and biochemical assays, radioligand binding, label free whole cell kinetics, fluorescent and luminescent calcium mobilization (FLIPR), and cAMP • These studies support high throughput screening, compound safety and selectivity, target validation, and assay development • Use automation to screen compounds; culture and plate cells; perform analysis of data; upload data, record assay parameters in a research notebook; and, generate reports. ...
Scientific Research Stamford, CT	· Effectively and efficiently contract with clinical and non-clinical suppliers (discovery institutions/organizations, preclinical and clinical CROs, bioanalytical laboratories, manufacturing, IVRS, Central Labs, Central ECG, drug packaging and distribution, preclinical studies, etc.) and interact extensively with internal business partners to meet the outsourcing needs of the specific Pharmaceutical R&D business partners, in line with Credo, Purchasing Ethics and Healthcare Compliance Gui...
Scientific Research Raritan, NJ	· Effectively and efficiently contract with clinical and non-clinical suppliers (discovery institutions/organizations, preclinical and clinical CROs, bioanalytical laboratories, manufacturing, IVRS, Central Labs, Central ECG, drug packaging and distribution, preclinical studies, etc.) and interact extensively with internal business partners to meet the outsourcing needs of the specific Pharmaceutical R&D business partners, in line with Credo, Purchasing Ethics and Healthcare Compliance Gui...
Scientific Research Los Angeles, CA	• The Scientist will support a broad range of consumer products such as Skin Care, Beauty Care, Baby Care, Oral Care, Wound Care, and Womens Health Care. • Execute technical aspects of projects with minimum supervision. • The individual will manage projects and interface with internal and external business partners. • Work in team environment with Operations, Marketing, Quality Assurance, and Research and Development (R&D). • Other key job functions/skills include the following – lab sca...
Scientific Research South San Francisco, CA	· Responsibility for liaising with business partners and other internal departments, and supporting the scientific and medical functions within safety group. · Provide project management support to PV group. · Provide management, general oversight, and support for all Pharmacovigilance Services (PVS) and Pharmacovigilance (PV) projects and activities, as applicable. · Provide input, advice, and direction, as applicable, and needs to ensure that projects are ru...
Scientific Research San Francisco, CA	• Partners with CTM/CPM to ensure site related start up through close out activities conducted per GCP, and regulatory requirements. • Vendor oversight and management is required, and identifies issues in a timely manner and escalates to management as appropriate. • Will complete monitor trip report review, site audit reports and monitors on site to assess for quality, GCP and regulatory compliance. • Monitor clinical studies for adherence to protocol, ICH/GCP, SOPs and follows Clinical Monit...
Scientific Research Spring House, PA	• Uses the principles and theories of science and mathematics to solve problems in R&D and to help invent and improve products-processes. • Perform qualitative and quantitative chemical analysis of raw materials. • Coordinates testing responsibilities to ensure QA test support according to the needs of Manufacturing to maintain continuous process flow. • Function as a team member in the QA Chemical Laboratories to provide timely test analysis information on the status of conformance to req...
Scientific Research San Francisco, CA	· Manages all aspects of study conduct in relation to data management: vendor oversight, study timelines, data quality and database lock deliverables. · Represents Data Management at Study Execution Team (SET) meetings and serves as point of contact for assigned studies with cross-functional teams. · Perform CRO oversight of Data Management activities for one or more trials of moderate to high complexity. · Prepares for and ensures database lock is achieved ac...
Scientific Research San Francisco, CA	· Participating in the collection, safety review, processing, quality review and reporting of adverse events data in compliance with applicable FDA and global regulations and Standard Operating Procedures (SOPs) and guidelines. · Safety Case Processing and Case Management in accordance with company procedures and guidelines. · Case processing of adverse event information received by the GPRM department for assigned products, and assists in the preparation of internal a...
Scientific Research San Diego, CA	• Work will involve dosing (sc, po, iv, other), animal handling and euthanasia, blood/tissue collection(s) as well as data collection and basic analysis. • Interact professionally with vivarium staff and research investigators within and outside of the direct CVM team. • Work well independently across a matrixed team environment and communicate effectively both one to one and in a group setting. • Work hours are approximately 8:00 AM to 4:00 PM (daily, Monday through Friday). ...
Scientific Research Raritan, NJ	• Create and negotiate the Clinical Trial Agreement with the investigators. • Provide the GTM with the initial study budget in liaison with local management. • Create local country recruitment and study plan, including key timelines and monitoring frequency, communicate to local team and/or to GTM and ensure that it is adhered to. • Prepare a country-specific ICF and if applicable a pharmacogenomic country-specific ICF in the local language(s) and ensure that the final draft of this docume...
Scientific Research Jacksonville, FL	• Create, revise, organize, edit and proofread technical documents and provide other documentation support to the Design Assurance, R&D group. • Bring clarity and consistency to design control and product development documents (standard operating procedures, SOP) through accurate and concise writing and effective use of document format. • Create design controls documentation to support the Design Assurance group. • Ensure that a consistently high standard of documentation is developed, app...
Scientific Research San Francisco, CA	· Applying multiple years of clinical testing laboratory experience, this position has a leadership role in Bioanalytical sample testing activities in support of Clinical studies. · Specifically, the successful candidate will have daily participation in PK/PD and biomarker analyses, review, and approval of results in LIMS, method improvements and new method dev/val., and authoring/reviewing SOP, protocols and reports. · Perform approver role in LIMS for Clinical sample ...
Scientific Research San Francisco, CA	· Responsible for clinical trial planning and execution of a given clinical trial program. · Ensure clinical trial(s) in a given program are conducted per ICH/GCP and regulatory compliance. · Work under the supervision of a Director and serves as primary clinical operations contact for trial management of a particular clinical program, depending on size and complexity of the program. · Overall responsibility for clinical trial timelines and budgets. · ...
Scientific Research San Francisco, CA	· Accountable for the day-to-day operations and execution of clinical trials to ensure the trial activities are conducted per ICH/GCP and regulatory compliance. · CTM works under the supervision of CPM/AD/Director on complex trial activities from start-up through database lock. · Serves as primary clinical operations contact managing protocol execution. · Manage clinical studies for adherence to protocol, ICH/GCP, SOPs and follows Clinical Monitoring Plan (on ...
Scientific Research Los Angeles, CA	· Work on process validation and cleaning validation teams · Responsible for supporting the document preparation and execution of validations in a semi solids manufacturing environment. ...
Scientific Research San Francisco, CA	· Partners with CTM/CPM to ensure site related start up through closeout activities are conducted as per GCP, and regulatory requirements. · Vendor oversight and management is required to identify issues in a timely manner and escalates to management as appropriate. · Complete monitor trip report review, site audit reports, and monitors on site to assess for quality, GCP, and regulatory compliance. · Monitors clinical studies for adherence to protocol, ICH/GCP...
Scientific Research SKILLMAN, NJ	Regulatory Affairs Specialist • Compiles all materials required in submissions, license renewal, and registrations • Fulfill International Documentation requirements in support of commercializing US products in international markets • Prepare supporting documents and secure information required for Export Certificates (e.g. Certificate of Pharmaceutical Product, Certificate of Free Sale, etc.) and submit to relevant health authority (FDA, Personal Care Products Council) • Assure that the...
Scientific Research San Diego, CA	• Analysis of ligand binding using radioligand displacement or time-resolved fluorescence methods, and analysis of cell responses using second messenger, gene reporter and cytokine release readouts. • Screening instrumentation, software spreadsheet management, and data analysis. ...
Scientific Research Raritan, NJ	• Will perform Serology Testing for in-process product to ensure product is meeting specifications. • Identify areas for process improvement including safety, environmental, quality, compliance, yield, productivity, and cost. • Work with Manufacturing Operations, Process Engineering, Process Development, Maintenance Operations, Automation, Engineering Systems, Quality Control, Quality Assurance, and Validation departments to implement process improvements. Assist with change control, equipme...
Scientific Research Los Angeles, CA	· Conduct exploratory research to produce new knowledge and potential products; conceives, organizes, promotes, and executes ideas and plans to increase chemistry’s role in and contribution to the discovery of chemical approaches to meet exploratory objectives in product discovery. · Perform qualitative and quantitative chemical analysis of bulk, raw material, and finished goods. Coordinates testing responsibilities to ensure QA test support according to the needs of Manufacturin...
Scientific Research Oak Ridge, TN	Please visit www.orau.org/jobs for a complete listing and descriptions of all available positions....

Receiving Jobs are currently available in these locations.

|   Scientist Job Devnville, NJ 07834   ||   Scientist Job Devnville, NJ 07834   ||   Various Positions Job Oak Ridge, TN 37831   ||   Regulatory Affairs Manager Job Sommerville, NJ 08876   ||   Clinical Research Associate II Job Jacksonville, FL 32099   ||   Health Economic Outcomes Statistics Consultant Job New Brunswick, NJ 08901   ||   Clinical Data Manager Job Titusville, NJ 08560   ||   Medical Writer Job Stamford, CT 06901   ||   Research Associate Job SPRING HOUSE, PA 19477   ||   QA Specialist Job Totowa, NJ 07512   ||   Safety Operations Scientist Job San Francisco, CA 94080   ||   Clinical Data Management Job San Francisco, CA 94080   ||   Research Associate Job San Diego, CA 92121   ||   Regulatory Labeling Associate Job Raynham, MA 02767   ||   Staff Scientist Job Raritan, NJ 08869   ||   Regulatory Affairs Specialist Job SOMERVILLE, NJ 08876   ||   CRA/Regional Monitor Job RAYNHAM, MA 02767   ||   Medical Writer Job HORSHAM, PA 19044   ||   Regulatory Affairs Manager Job Princeton, NJ 08540   ||   Clinical Submissions Specialist Job Wilmington, DE 19801   ||   Clinical Program Manager Job San Francisco, CA 94080   ||   Clinical Trial Manager Job San Francisco, CA 94080   ||   Medical Writer Job Raritan, NJ 08869   ||   Validation Technician Job Los Angeles, CA 94080   ||   Clinical Trial Administrative Coordinator Job San Francisco, CA 94080   ||   Sr. Clinical Trial Specialist Job San Francisco, CA 94080   ||   Research Associate Job San Diego, CA 92121   ||   Serologist Job Raritan, NJ 08869   ||   Scientist/Chemist Job SKILLMAN, NJ 08558   ||   CRA/Regional Monitor Job WARSAW, IN 46582   ||   Scientist Job Radnor, PA 19087   ||   Regulatory Affairs Specialist Job SKILLMAN, NJ 08558   ||   Regulatory Affairs Specialist Job Jacksonville, FL 32099   ||   Sr. Product Safety Scientist Job Horsham, PA 19034   ||   Clinical Research Assistant Job Wilmington, DE 19802   ||   Regulatory Technical Writer Job Jacksonville, FL 32566   ||   Clinical Supplies Associate Job LOS ANGELES, CA 90001   ||   Drug Safety Associate Job San Francisco, CA 94102   ||   Product Complaint Process Consultant Job Stamford, CT 06901   ||   Clinical Trial Auditor Job San Francisco , CA 94080   ||   Regulatory Affairs Specialist Job Jacksonville, FL 32256   |