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Position/Location	Mini Description (81 Job Postings)
Scientific Research Wilmington, DE	- Review plans and deliverables from Contract Research Organizations - Support clinical studies in which most operational and programming tasks will be outsourced to CRO. - Work with physicians and teams to design clinical studies - Collaborate face-to-face with study teams onsite - Review study proposals - Write Statistical Analysis Plans (SAP) and sections of protocol - Review SAPs, Data Presentation Plans and protocols - Review data for validity and evaluability - Review an...
Scientific Research Wilmington, DE	- Lead deliver committed components of clinical studies according to agreed resources, budget and timelines - Comply with Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations - Ensure sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived...
Scientific Research Wilmington, DE	- Manage safety data using analytical skills, providing scientific or technical input to safety surveillance for products in development or for drugs on the market, and serves as a regulatory, safety and clinical resource for maintaining accurate safety profiles for company products - Reviews summary safety documents for accuracy, completeness and validity prior to regulatory submission - Prepare Safety Surveillance Reports, regulatory summary reports, and other customized reports required to...
Scientific Research Jacksonville, FL	- Support cross-functional and cross-sector expert teams by assuring established processes are followed, including communication and documentation needs. - Update the project management processes (including definition, planning, education, risk management, project control, and change management) to ensure that activities are carried out according to agreed upon governance. - Coordinate meeting set-ups for both Independent Review and the R&D Council. - Help communicate policies and mes...
Scientific Research Wilmington, DE	- Act as scientific lead for Epidemiology in drafting of SDCs and protocols, during the analyses phases and in interpretation and reporting of results - Represent Epidemiology Department in RMP or other safety related meetings and/or deliverables - Represent Epidemiology Department in Payer-related meetings and/or deliverables, and conducting literature surveys - TA CVGI project support...
Scientific Research Cincinnati, OH	- Responsible for initiation, monitoring, completion, and reporting of clinical trials under direct supervision. - Monitor the general progress of trials, e.g., patient enrollment, administrative activities. - Assist in preparation of case report forms, investigator brochures and related documentation by coordinating and utilizing input from various sources: literature, experts, and internal team members. - Implement trials, including CRO interaction, investigative site preparation, investi...
Scientific Research Jacksonville, FL	- Conduct microbiology testing of contact lens and lens care products using a variety of microorganisms. - Work closely with a multifunctional team focusing on biological research of contact lenses and the ocular surface. - Adhere to environmental policy, procedures, and supports department environmental objectives. - Design, conduct and interpret biological experiments to support research and development programs using a variety of methodologies - Data analysis and preparation of reports...
Scientific Research Skillman, NJ	· Oversight of case management and regulatory reporting activities for Consumer monograph, cosmetic and medical device products. · This individual will establish Quality Assurance / Quality Control procedures to ensure quality of processed cases meets required targets, is consistent and accurate with source documents and is compliant with applicable procedures/guidelines. · Monitor regulatory submission compliance metrics and initiates non-conformance with defined ...
Scientific Research Malvern, PA	? [INVALID]s manufacturing processes according to Technical Operations and Operational Services standard operating procedures ? Verifies and enters production parameters per SOP and Batch Record on trained procedures ? Retrieves and analyze trend charts and process data on trained procedures ? Accurately completes documentation in SOP's, logbooks and other GMP documents ? Wear the appropriate PPE when working in manufacturing and other hazardous working environments ? Takes necessary ac...
Scientific Research Springhouse, PA	· Technical Writers need to be able to understand complex scientific information, theories and practices. · The successful candidate will function as a team member in the PDMS Lifecycle Management group to provide timely review of specification and test method. documents in relation to the conformance to predefined standard requirements · The writer will investigate departures and abnormalities and implements corrective action. · The writer will author...
Scientific Research West Irvine, CA	• Under minimal supervision establish and maintain quality assurance programs, procedures and controls ensuring the performance and the quality of products conforms to the established company standards, QSR and ISO directives • Solve Quality Lab problems, investigate lab testing anomalies and implements corrective action • Audit documentation and test methods for compliance • Assist in projects including the validation of test methods and qualification of lab instrumentation • Write protoco...
Scientific Research Wilmington, DE	• Manage the supply chain for a portfolio of global clinical studies across all phases within a drug development program • Lead cross functional Study Drug Delivery Teams and represent these teams on the R&D Supply Chain Team • Collaborate with customer functions to influence and manage demand for individual studies, and is responsible for their supply chain deliverables through leadership of the Study Drug Delivery Team • Understand and translate clinical study protocol requirements into de...
Scientific Research Hampton, VA	Are you seeking an opportunity to work alongside NASA's finest researchers? The LARSS program may be your ticket to doing just that. LARSS is a Center-unique paid internship program managed for NASA by the Virginia Space Grant Consortium (VSGC) under a sub-award from the National Institute of Aerospace (NIA). NASA Langley Research Center (LaRC) invites rising undergraduate juniors and seniors, and graduate students (master's or doctoral level) who are purs...
Scientific Research Malvern, PA	• Biologics (USP) will function as a member of a team to develop and scale-up mammalian cell culture processes • Contribute to upstream process development, under the direction of his/her immediate supervisor • Setup, execute, and support laboratory studies including media preparation, preculture, and bioreactor operations • May also participate in purification, viral filtration and tangential flow filtration studies...
Scientific Research Fort Washington, PA	• Provides testing, technical, and troubleshooting support in the QC laboratories • Collection, processing, and testing of chemical components, bulk products, raw materials, packaging components, finished products, marketed product stability, in-process materials, scale up, validation and cleaning validations to conform with specifications and standard operating procedures (SOPs) • Reviews and/or writes technical documents such as SOPs, test protocols, APRs and laboratory investigation...
Scientific Research Skillman, NJ	• Responsible for the management of clinical supplies during trial execution ensuring successful dose and achievement of a Targeted Trial Scrap R&D for large and small molecules, for all phases of clinical trials. • Management of clinical supplies during the execution phase of a clinical trial according to timelines and will be responsible to stay within budget, and meet all SOP, GMP, and regulatory requirements. • Will manage and adjust campaign strategies and inventory management systems inc...
Scientific Research Malvern, PA	• Responsible for the management of clinical supplies during trial execution ensuring successful dose and achievement of a Targeted Trial Scrap R&D for large and small molecules, for all phases of clinical trials. • Management of clinical supplies during the execution phase of a clinical trial according to timelines and will be responsible to stay within budget, and meet all SOP, GMP, and regulatory requirements. • Will manage and adjust campaign strategies and inventory management systems inc...
Scientific Research Raritan, NJ	· Work with technical, manufacturing, and quality groups to develop a Criticality Analysis document for pharmaceutical products. · Assist teams by pre-populating the document based on provided process flow diagrams, manufacturing batch records and other supporting documents. · Incumbent should have the ability to search these documents, understand the process and extract required information · Ensure proper formatting, proof read, and route for approval...
Scientific Research Jacksonville, FL	· Under general supervision, plan, and monitor human clinical trials in compliance with internal standard operating procedures, Good Clinical Practices (GCP) and applicable Regulations and Guidelines. · Coordinate protocol, informed consent, and case report form development and compilation. · Insure appropriate trial agreements are signed and materials are distributed. · Complete source document verification, query generation and acceptance, an...
Scientific Research San Diego, CA	· Develop/Write Phase I/II Clinical Trial Protocols · Manage/coordinate all aspects of clinical trial, including operations and contracting · Lead and/or manage protocol development, including coordination of protocol-related reviews and writing of protocol · Coordinate writing of IB, CSR and other clinical documents · Lead phase I/II working group meetings and clinical team meetings as needed, including preparation of agenda, minutes, and act...
Scientific Research Stamford, CT	• Assure that validation of computerized systems is complete and meets regulatory expectations by: o Review and approve systems validation plans, protocols and reports, Software Development Life Cycle (SDLC) documentation and standard operating procedures for computerized systems and equipment. o Participate on computerized system project teams as the quality unit representative. o Support continuous improvement and remediation for areas identified by internal audit and planning. ...
Scientific Research Cranbury, NJ	• Assist Pharmaceutical and Analytical Personnel with the introduction of Planisware. • Assist non-clinical team leaders by providing project-management assistance. • This will include team coordination, organizing meetings, capture, and follow up of action items, preparation of plans based on line-unit input. • Project Management in a CMC/non-clinical department. • Experience in using Planisware for CMC/non-clinical activities – with access greater than "read"...
Scientific Research Los Angeles, CA	· Bachelor's degree or professional experience (minimum of 5 years) equivalent required (Life Sciences background preferred - Pharmaceutical, Biotech, and/or CRO). · In-depth knowledge of current industry standards (i.e., CDISC, SDTM, CDASH, etc.) required. · Experience in clinical drug development within the pharmaceutical industry or related industry required. · Oncology therapeutic area experience preferred. · E...
Scientific Research Malvern, PA	· Function as a member of a team to develop and scale-up mammalian cell culture processes. · Will contribute to upstream process development, under the direction of his/her immediate supervisor. · Setup, execute, and support laboratory studies including media preparation, pre-culture, and bioreactor operations. · The candidate may also participate in purification, viral filtration, and tangential flow filtration studies....
Scientific Research Raritan, NJ	· Review and facilitate signing of documents including Power of Attorney, Letters of Authorization, etc. by internal and external partners, follow by tracking of notarization/legalization and shipment. · Track documents throughout the process and resolve issues related to delays or lost requests. · Ensure documents are completed and arrive at affiliates before due dates. · Significant amount of contact with international markets regional leads to clarif...
Scientific Research Stamford, CT	· Sr. CDC will provide support in reviewing legacy data supporting a submission. · For the potential data discrepancies identified, the Sr. CDC will research each issue and compile appropriate CRFs, DCFs, data listings etc. · Provide a preliminary evaluation of the issue and provide the compiled information to manager for review. · Under the direction of a senior staff member, the Sr. CDC will be assigned to manage 2 ongoing phase 3 studies to database ...
Scientific Research Somerville, NJ	· Work with Sr. Leadership on the management of the product lines and suppliers to include product changes, additions, and deletion. · The Regulatory Manager will work with an international supplier base on documentation to support both an internal and FDA compliant quality system and product registrations. · Serve as the Project Manager for the entire product line to ensure all documents are complete, accurate, and well maintained. · Assure all record...
Scientific Research Northbrook, IL	• Provide specific pharmacoepidemiology expertise using appropriate methodologies and tools in researching the natural history of diseases and therapies in order to understand the standards of practice associated with the development of new chemical/molecular entities and/or use of company's marketed products. • Provide scientific leadership to internal and external cross-functional stakeholders (Clinical, Regulatory, Biostatistics, etc.) to design, develop, and [INVALID] PE studie...
Scientific Research Northbrook, IL	· Update and operationalize PV Management Plans and/or Operational Procedures. · Assist in operational oversight of case processing activities. · Work with in-licensing partners in clinical trial arena to define processes for case exchange between co-development partners. · Work with case processing vendor to implement processes developed as a result of in-licensing collaborations. · Represent pharmacovigilance operations in clinical teams. ...
Scientific Research Rochester, NY	· Analytical testing of patient samples and other fluids. · Calibrators, controls, CAP, SRM, ERF) to support the release process, stability, accuracy testing, and new method development, using multiple instrumentation including centrifugal analyzers (Cobas FARA), manual spectrophotometers (DU640), Olympus AU400, flame photometers (IL943), atomic absorption (Perkin Elmer Analyst 300), RIA (tritium), HPLC (Waters/Millennium), ...
Scientific Research Northbrook, IL	• Provide safety and surveillance support throughout product lifecycle. • Provide strong leadership and chairs a multidisciplinary safety team including signal detection, risk management and other activities related to managing the safety profile for assigned products. • Medically assesses single cases, and analyzes, evaluates, and interprets aggregate adverse event data, including conducting signal detection using appropriate tools and methodologies. • Prepare internal and external report...
Scientific Research Raritan, NJ	· Analytical R&D will support R&D and work with QA and Operations by developing, validating and transferring analytical methods and analyzing raw materials and products (in-process and finished) . · Design and carry out experiments to solve technical problems. · Carry out forced degradation study and identify impurities/degradation products. · Develop and optimize analytical methods for testing of drug substance and products. · Conduct...
Scientific Research Malvern, PA	• The scientist will perform cell culture according to Standard Operating Procedures using Good Manufacturing Practices. • Primary responsibilities will be 1] Culture and cryopreservation of a variety of cell lines 2] Preparation and tracking of test samples to external test laboratories 3] Inventory and shipment of cells to customers. • Culture and cryopreserve CHO, murine and human cells using good aseptic technique and following Standard Operating Procedures and current Good Manufacturing ...
Scientific Research San Francisco, CA	· Vendor management (e.g. CROs, IVRS, Imaging) including initial SOW, budgets, vendor performance management, issue escalation and resolution and managing vendors to their scope. · Key content leader for vendor oversight plans and will have responsibility for certain vendor oversight plans · Responsible for creating and maintaining study specific ICFs. · Will prepare sections of protocol and amendments. · Develops and maintains guidance and pr...
Scientific Research Fort Washington, WA	· Risk evaluations for drug, device, and cosmetic products, [INVALID] risk management plans, be responsible for compiling regulatory submissions, label justifications, and the medical assessment of safety profiles for all products in assigned franchises. · Review and analysis of safety-associated issues that might be due to product quality or manufacturing issues for the analysis of safety surveillance observations, and for the response to safety inquiries from the Medical Safety...
Scientific Research Los Angeles, CA	· Responsible for technical support to the manufacturing facility and general marketed product support for cosmetic, personal care and OTC monograph drug products · Work, under supervision, in a team environment with Operations, Supply Chain, Quality Assurance, Product Development, Technical Transfer, Analytical Development, Microbiology, Regulatory, and Marketing Personnel. · Technical service support to the LAP manufacturing facility on NC/CAPA investigations and prod...
Scientific Research Malvern, PA	· Set up, operate and maintain laboratory bacterial fermentors and supporting lab instruments, monitors experiments, makes observations, calculates and records results, and develops conclusions. · Perform all manufacturing processes in accordance with GMPs, SOPs, TMs safety rules, and production schedule. · Under general supervision follow SOPs and special test designs; analyzes test data and completes required documentation. · Perform QC/equipment mainten...
Scientific Research San Francisco, CA	• Responsible for the receipt, data entry and distribution of adverse event reports following Company Standard Operating Procedures, internal business practices and regulatory guidance documents to ensure compliance with worldwide safety regulations, corporate policies, and partnership agreements. • Process case information received via e-mail, fax, and mail. • Maintain paper or electronic documentation of key information, as applicable; and accurately labeling, naming, and filing according ...
Scientific Research Raritan, NJ	Manage all consulting agreements, contracts, and clinical trials for the department. · Collect agenda items from MSLs. Prepare agenda and distribute to committee members 1 week in advance of meeting/upload agenda in SharePoint. Run IIS Committee meeting. · Process purchase orders and check requisitions. · Work with Finance on a quarterly basis for accruals. · Schedule grant committee meetings, attend the monthly meetings, and take minutes. · Proc...
Scientific Research Raritan, NJ	• Develop and document programs to create analysis datasets summarizing key clinical trial data. • Develop and document programs and to produce tables, listings, and other reports. • Perform and document quality control checks for programs. • Assist in testing and implementation of new and updated internally and externally developed software as well as new SAS releases. • Participate in the development and review of study-specific procedures • Assist with the development of case report ...
Scientific Research Totowa, NJ	•Perform reviews of pertinent batch documentation from company 3rd party suppliers for completeness and accuracy •Facilitates any applicable corrections with 3rd party suppliers to support batch disposition and ensure cGMP compliance •Collates APR element data and summarizes in reports for all company 3rd party manufactured products •Acts as liaison between 3rd party suppliers and company for document management (Batch Records, Complaints, APRs, Stability, etc.) •Track 3rd party doc...
Scientific Research Totowa, NJ	• Maintenance of Audit databases (must be very proficient in Word, Excel and Access ) • Coordination of GLP audit scheduling • Coordination of review and approval of GLP audit reports • Scanning and e-mailing of Clinical Packaging/GLP master documentation to external departments and customers • Scanning of all completed clinical batch records into shared drive; filing and archival to Cranbury documentation vault • Cataloging and sub-cataloging in-process and complex clinica...
Scientific Research Fort Washington, PA	• Responsible for clinical trial planning and execution of a given clinical trial program ensuring that clinical trials in a given program are conducted per ICH/GCP and regulatory compliance. • Has overall responsibility for clinical trial timelines and budgets • Provides guidance and oversight for the successful management of all aspects of global clinical trials within designated program budgets and timelines • Responsible for development and monitoring of clinical program budgets and timel...
Scientific Research Warsaw, IN	· This individual will be responsible for the adverse/safety event review process within Orthopaedics, as well as fostering strong, productive relationships with colleagues within the Organization. · Process, review, manual medical coding, follow up and reporting of safety events as part of the safety management within Investigator Initiated Studies and Clinical Registries (DOTS). · Under general supervision, accountable for the timely tracking and ensuring comp...
Scientific Research Los Angeles, CA	• Work with team on protocol design and writes statistics section of protocols. • Write analytical plan and leads detailed analysis planning; participates in other trial setup activities. • Analyze and interprets data; writes statistical methods section for clinical study reports. • Assist in clinical development planning for new drug indications. • Assist project statistician in preparing development programs for new drug indications. • Provide/lead primary statistical input fo...
Scientific Research FORT WASHINGTON, PA	• Responsible for the management, collation and generation of project specific SOPs, QSPs, WWSPs. • Project is consumer product surveillance focused; previous experience working in PV environment or comparable organization required (ie, pharma). • Must be able to manage timelines, global staff (head of group resides in UK), [INVALID] team on progress, schedule 1:1 meetings with subject matter experts, and [INVALID] visio flows from discussions. • Flows are then moved in...
Scientific Research Horsham, PA	· Case series review or review of tabulated data; review of safety surveillance data including trend information · Production of draft safety summary reports and safety review team summaries/slides · Provide support to related PV activities such as preparation of ad-hoc and aggregate regulatory reports and labeling support documents · Understanding and following departmental and company systems and procedures · Participating in departmental proje...
Scientific Research San Francisco, CA	· Case series review or review of tabulated data; review of safety surveillance data including trend information · Production of draft safety summary reports and safety review team summaries/slides · Provide support to related PV activities such as preparation of ad-hoc and aggregate regulatory reports and labeling support documents · Understanding and following departmental and company systems and procedures · Participating in departmental proje...
Scientific Research San Francisco, CA	· Partner with CTM/CPM to ensure site related start up through close out activities are conducted as 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. · Monitors clinical studies for adherence to protocol, I...
Scientific Research Stamford, CT	· Partner with CTM/CPM to ensure site related start up through close out activities are conducted as 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. · Monitors clinical studies for adherence to protocol, I...
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 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 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 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 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 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...

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   |