Great Careers in Clinical Research, Medical Technology, Information Technology, Engineering and Scientific Research

Serving many of the Nation's leading Engineering, Scientific, and Research Companies, Fladger Associates is a professional, National Executive Search and Human Capital Solutions Firm specializing in licensed, degreed, or certified professionals in Research and Scientific Fields such as Pharmaceutical Research, Medical Technology, Information Technology, Clinical Research, Bio-Engineering, and Clinical Quality Assurance.

To be considered for employment opportunities with many of the Nation's leading Medical Technology and Research Firms, simply SUBMIT a copy of your resume. Or, review Fladger Associates' current Engineering and Scientific Employment Opportunities and submit an application.

Fladger Associates is looking for the very best Engineering and Scientific Professionals to fill the following jobs!

Position/Location	Mini Description (123 Job Postings)
Analytical Chemist Warsaw, IN	• Employee will follow laboratory procedures and safety guidelines, maintain detailed laboratory notebooks, and prepare technical reports as needed. • 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....
Analytical Chemist Skillman, NJ	• Responsible for conducting analytical technical support for development of consumer products • Perform material and products testing, methods development, method validation, method transfer, stability testing • Trouble shoot product and process issues • Preparation of documents for supporting product launches and/or regulatory submissions ...
Analytical Chemist CORNELIA, GA	Responsibilities • Performs 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. • Could function as a team member in the QA Chemical Laboratories to provide timely test analysis information on the status of conformance to requirements. • Investigates testing abnormalities and implements corrective action. • Audits documentation, devi...
Ariba Systems Administrator Wilmington, DE	· Business analysis for enhancements and updates to the US and UK ezBuy systems. · Adding and maintaining e-catalogs in the ezBuy systems and enabling suppliers on the Ariba Supplier Network (supplier enablement.) · Gathering systems testing, functional design, change management skills required. ...
Associate Research Scientist Cranbury, NJ	• Following sample analysis responsible for calculation, processing, review and compilation of the results. • Perform routine, method validation and research experiments with moderate supervision. • Preparation of solutions (e.g. mobile phase, dissolution medium, standard and sample solutions) and analysis of samples according to compendia/written procedures. • Interpret analytical data in regards to acceptability and consistency and help maintain analytical instrumentation. Provide ac...
Business Analyst Wilmington, DE	• Business Analyst will provide technical, business function, and process expertise for the development, implementation and support of business process and business systems • The primary responsibility will be to use their specialist knowledge and understanding of the business area direction and priorities to drive innovative solutions to information issues and challenges faced by the customer area • In addition, the Business Analyst plays a key role as a subject matter expert in the design a...
Cell Biologist Cranbury, NJ	· Specific duties include cell culture, setting up and executing beta-arrestin assay, testing of PBEB5 compounds, setting up and executing the following assays: cAMP assay, Western blot, ELISA, immunostaining, receptor binding. · Analyze results and enter into the database....
Chemist 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...
Chemist Skillman, NJ	· Use 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 sta...
Chemist ATHENS, GA	• Conduct process research and development in diverse range of chemical development projects that seek to maintain or improve manufacturing costs, yields, quality and/or capacity, as well as evaluate new business opportunities • Plans, performs and reports laboratory work in support of developing new processes, technology transfers, and improving existing processes • Development and performance of laboratory/pilot experimental design • Collection of experimental data, data interpretation and...
Chemist ATHENS, GA	Chemist • Tests and analyzes raw materials, in-process samples and products such as chemicals and Active Pharmaceutical Ingredients to determine stability, purity, chemical content, and other characteristics • Follows standardized formulas or experimental procedures, documents test results • Provides technical expertise to internal customers and other lab personnel • Reviews peer laboratory data to ensure accuracy and completeness • Coordinates and performs calibration of new laboratory...
Chemist LOS ANGELES, CA	Chemist • Investigates properties, composition, and structure of matter and the laws that govern the combination of elements and reactions of substances. • Conducts exploratory research to produce new knowledge and potential products; conceives, organizes, promotes, and executes ideas and plans to increase chemistrys role in and contribution to the discovery of chemical approaches to meet exploratory objectives in product discovery. • Develops research proposals to provide a technically an...
Chemist WIimington, DE	Chemist Primary Job Responsibilities and Qualifications: • QC laboratory Chemist will use HPLC and other lab equipment and systems to test tablets, raw material, and water • Good knowledge of wet chemistry and chromatography required • Able to competently use a range of laboratory computer and information systems Degree / College Major: BS/Chemistry or Biology ...
Chemist- Associate Research Scientist 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. · ...
Chemist-II Los Angeles, CA	• In a team setting and cGMP environment, perform test method validation – protocol, execution, report, and transfer. • Prepare data and documentation using calculators and computer software. • Evaluate and investigate results from various analyses. • Properly dispose of sample preparations and solutions according to safety and environmental procedures. ...
Chemist-II Raynham, MA	· Sample analysis, method development, and characterization of complex carbohydrate products. · Analytical method qualification, formulation development and analysis, stability, forced degradation and comparability studies. · Work independently in the laboratory. ...
Clinical Contract Specialist 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...
Clinical Data Management 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...
Clinical Data Manager Titusville, NJ	Clinical Data Manager • Direct and supervise all aspects of the data management process, ensuring compliance with FDA regulations related to data management including external resources and CRO • Provide guidance to Clinical Database Administrator • Ensure compliance with department procedures • Provide input into Case Report Forms (CRF) design and approve CRFs for production use • Validate database design; program edit-check procedures and validate new edit-check processes • Run batch...
Clinical Education Learning Partner Wilmington, DE	• Determine learning needs according to agreed strategy to achieve current and future business needs. • Design and project-manage medium-sized education programs that will drive improvements in the business performance. • Manage the portion of the central E&L budget as assigned to specific project(s) and ensure that it comes within agreed targets • Work with internal and external Knowledge Experts to achieve desired program content. • Develop contracts for each learning program and agree t...
Clinical Operations Manager RARITAN, NJ	• Responsibilities include study design, protocol development and execution of clinical trials • Act as a liaison between company and clinical investigators, and develop credible relationships with opinion leaders, medical directors, and key stakeholders • Also be responsible for medical monitoring/reporting and company safety officer activities • Evaluate adverse events (pre and post-marketing) for relationship to treatment, and will support the interpretation, reporting of results, and pre...
Clinical Program Manager 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. · ...
Clinical Research Assistant Wilmington, DE	· Contribute to clinical study start-up, execution, close-out and reporting · Collect, review and track regulatory and other relevant documents. · Interface with Investigators, Strategic Partners, Marketing Companies and internal staff during the collection process to support effective delivery of a study and its regulatory documents through finalization of the Clinical Study Report (CSR). · Initiate and lead the set-up of the Study Master File (SMF) including ...
Clinical Research Associate II 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...
Clinical Research Associate/CRA RAYNHAM, MA	· Oversee the conduct of assigned clinical studies including acting as liaison to clinical investigators, ensuring the quality and integrity of data · Prepare and conduct study initiation, closeout and monitoring visits at clinical investigative sites to ensure adherence to procedures, protocols and project plans in accordance with FDA regulations. Maintain site files, trial master files and study documentation · Develop status reports, SOP revisions and document q...
Clinical Research Manager Wilmington, DE	· Develop and implement strategic clinical program feasibility and recruitment methodologies to support CPTs and program investment decisions and further planning activities. · Develop recruitment options for clinical programs based on study design specifications and direction of CDD. · Recommend and decide on allocation of patients in internal studies based on geographic allocation strategy, design, option focus. · Serve as the subject matter expert within t...
Clinical Research Scientist RARITAN, NJ	Clinical Research Scientist • Responsibilities will include supporting/driving study design, protocol development and execution of clinical studies • Act as a liaison between company and clinical investigators • Also responsible for medical monitoring/reporting and company safety officer activities • Evaluate adverse events (pre and post-marketing) for relationship to treatment, and will support the interpretation, reporting of results, and preparation for FDA submissions. • Travel (inclu...
Clinical Safety Scientist RARITAN, NJ	Clinical Safety Scientist Responsibilities: • Working in Medical Monitoring group monitor safety of clinical trials • Review Case Report forms, SAE and Patient safety data • Evaluate adverse events for relationship to treatment • Reconcile Safety Database • Prepare safety data for FDA submissions for ongoing clinical trials ...
Clinical Submissions Specialist Wilmington, DE	• 2+years work experience required • Strong Clinical or Regulatory Submission Managment skills, including publishing of all types of Clinical documents, including eCTD (electronic Common Technical Document) advanced knowledge. • Detailed knowledge of submissions ready standards and aware of ER/ES requirements. • Advanced knowledge of Documentum system. • BA/BS preferred, but not required...
Clinical Supplies Associate 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...
Clinical Trial Administrative Coordinator San Francisco, CA	• Support the clinical trial activities within Clinical Operations. • Works closely with Clinical Operations and cross functional staff members to support the administrative duties related to the conduct of clinical trials. • Assist with Regulatory document review in accordance with ICH/GCP and local regulatory requirements. • Distribution of study related communication with sites/CRO/ study team personnel, site feasibility survey; IND safety report tracking. • Assist the study team in c...
Clinical Trial Auditor 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...
Clinical Trial Manager 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. · Serves as primary clinical operations contact managing protocol execution. · Manages clinical studies for adherence to protocol, ICH/GCP, SOPs and follows Clinical Monitoring Plan (on site quality visits, review & approve trip reports, monitor metrics of vendor/site performance). · Responsible for c...
Clinical Trial Manager 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 ...
Clinical, Education & Learning Consultant Wilmington, DE	• Determine learning needs according to agreed strategy to achieve current and future business needs. • Design and project-manage medium-sized education programs that will drive improvements in the business performance. • Manage the portion of the central E&L budget as assigned to specific project(s) and ensure that it comes within agreed targets • Develop evaluation data and metrics for defined education programs and use these to determine the impact of learning on department/business obje...
Consultant Regulatory Affaire King of Prussia, PA	•Serves as the RA representative to the core project teams or represents the RA site as project teams for assigned projects providing regulatory support for investigational projects and market applications. •Serves as FDA contact for assigned projects. Work with management and Project Team members to develop strategies and advice for addressing the issues for developmental and marketed products. •Represent the company during interactions with regulatory agencies. •Prepare or manage the pre...
CRA 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...
CRA/Regional Monitor WARSAW, IN	• Responsible for site management and clinical monitoring in accordance with contractual agreements, department guidelines, work instructions, applicable federal and state regulations, and ICH guidelines. • Position is scheduled for 40 hours per week; Travel approximately 60-70%. • Periodic travel to Sponsor headquarters for up to 1 week at a time required • Efficiently manage between 6-8 study sites • Proficiency in timely and accurate completion of case report forms, scheduling of patient...
CRA/Regional Monitor RAYNHAM, MA	• Responsible for site management and clinical monitoring in accordance with contractual agreements, department guidelines, work instructions, applicable federal and state regulations, and ICH guidelines. • Position is scheduled for 40 hours per week; Travel approximately 60-70%. • Periodic travel to Sponsor headquarters for up to 1 week at a time required • Efficiently manage between 6-8 study sites • Proficiency in timely and accurate completion of case report forms, scheduling of patient...
Design Control Specialist/Regulatory Affairs Jacksonville, FL	• Provide technical support for Regulatory Submissions and approvals. • Act as key partner with Technical Product and Process Project Teams. • Provide technical support to the project team, partnering with regulatory compliance and submissions to ensure that global registration and compliance requirements are met • Serve as a subject matter resource for partnering with regulatory submissions, compliance and project teams in support of regulatory strategies. • Provide technical support to ...
Drug Safety Associate 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...
Drug Safety-Pharmacovigilance Scientist Horsham, PA	Drug Safety-Pharmacovigilance Scientist • The principle responsibilities of this position include identification of safety signals, thorough evaluation and analysis of safety data, and communication of pertinent safety information with recommendations to Sr. Management • Plans and writes draft, Periodic Safety Update Reports (PSURs), expert reports, topic reviews and justification documents. • Performs periodic aggregate reviews of safety data to identify and analyze safety signals • Co...
Formulation Chemist LOS ANGELES, CA	Formulation Chemist • Investigates properties, composition, and structure of matter and the laws that govern the combination of elements and reactions of substances • Conducts exploratory research to produce new knowledge and potential products; conceives, organizes, promotes, and executes ideas and plans to increase chemistrys role in and contribution to the discovery of chemical approaches to meet exploratory objectives in product discovery • Develops research proposals to provide a t...
Global Pharmacovigilance Physician South San Francisco, CA	· Assist the GPRM team to help ensure proactive, robust and timely assessments of safety data to characterize the emerging safety profiles of the assigned products within the Alzheimer Immunotherapy Research & Development portfolio. · Communication of safety issues and risks when appropriate, to both internal and external stakeholders, including Senior Management, Health Authorities (HA), Investigators and/or Patients and when appropriate, the design and implementation of risk mi...
Good Clinical Practices (GCP) Auditor Jacksonville, FL	• Review/assess clinical processes for compliance to federal regulations, International Conference for Harmonization (ICH) and Good Clinical Practices (GCP) guidelines, company SOPs and other relevant state or local regulations. • Partner with clinical operations and other clinical QA personnel to develop/enhance clinical processes and associated Sops where gaps exist. • Conduct and document GCP audit clinical investigational sites and Clinical Research Organizations (CRO’s). • Audit on-sit...
Health Economic Outcomes Statistics Consultant 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...
IS Analyst Wilmington, DE	· Work as part of the Technology & Data workstream within company program to lead the IS work for HR around Delegation of Authority (DOA) and Long Term Incentives (LTi) · Leading the user acceptance testing of the LTi and DOA functionality · Leading the defect management and resolution with the 3rd party suppliers (NGA) of this functionality. · Leading the development and testing of the interfaces · Be aligned with Global Solution Architects to become ...
Laboratory Technician Cranbury, NJ	• Verify the analytical balances and pH meter on daily basis. • Prepare solution like mobile phase, dissolution medium and diluents • Keep laboratory supplies ready by inventory stocking; placing orders; verifying receipt. • Support laboratory staff with activities such as maintaining glassware, chemical and reference standard inventory; verify analytical balance and pH meter calibration • Document experiment and results in notebook. • Preparation of solutions (e.g. mobile phase, disso...
Medical Communication Specialist West Irvine, CA	· Maintain the quality process associated with product complaint handling, procedures and controls to ensure that all complaints, inquiries, technical and clinical support requests are processed in accordance with established company procedures and worldwide regulations and standards. · Assist customers via phone and virtual based applications in technical and or clinical peer-to-peer support. · Liaise with field engineering teams to ensure customers on site support needs an...
Medical information Manager TITUSVILLE, NJ	Medical information Manager • Medical information Manager serves as the contact for provision of medical information in support of operating company initiatives. This product knowledge expert develops medical information tools, conducts training sessions for scientific knowledge and is responsible for medical accuracy • Develops medical information materials including but not limited to standard replies, formulary dossiers, slide decks and presentations in support of customer needs • Prov...
Medical Technologist POMPANO BEACH, FL	· Specializes and recognized through accreditation in one of the following areas of the laboratory: Chemistry, Hematology, Blood Banking, Immunology, or Microbiology. · Blood Bank and some basic microbiology experience,( general micro, pour plate method, no Identification required)...
Medical Writer Raritan, NJ	• Write technical materials, such as SOPs, appendices • Assist the technical teams in drafting SOPS and technical reports • Collect required technical documents to author reports according to the defined SOPs • Ensure the timely review and approval SOPs and reports with the predetermined review teams, including, but not limited to, plant technical groups, QA, analytical, chemical development, biological development and pharmaceutical development scientist and r...
Medical Writer Stamford, CT	Medical Writer • Serve as the medical writer of regulatory medical research documents such as clinical study reports and protocols • Participate on several study teams as the designated medical writing functional representative and review the work of medical writing counterpart at the Clinical Research Organization (CROs) in the preparation of protocols and clinical study reports • Write protocols and clinical study reports • Post the results of clinical trials on clinicaltrials.gov. • Un...
Medical Writer Stamford, CT	• Prepare medical research manuscripts for publication in medical journals and medical research posters for presentation at healthcare association meetings. • Serve as the medical writer of nonregulatory medical research documents such as manuscripts and posters of clinical studies, all intended for healthcare audiences. ...
Medical Writer HORSHAM, PA	• Author a variety of product-related topics by organizing, analyzing, and interpreting scientific and statistical data • Write content for a clinical company website that will go through review by the Promotional Review Committee • Review protocols, clinical data reports, and published literature • Utilize Arbotext and Documentum authoring technology • Participate in program teams, coordinate and conduct document-related meetings including the preparation of a pre-meeting agenda and pos...
Medical Writer-Regulatory Communication Scientists Wilmington, DE	· Lead the authoring of clinical regulatory documents for label-focused submissions (eg, Common Technical Documents for NDA and MAA applications) · May lead the communication elements of whole projects or subprojects (eg, submission workstreams on efficacy or safety), and tackle key documents within a program. · Work as part of clinical project teams to provide communications support, guidance and advice across global Clinical organization, and to alliance partners · ...
Microbiologist-I Jacksonville, FL	• Establish and maintain quality assurance programs, procedures and controls, ensuring performance parameters of both the products and quality system elements are continually measured to drive improvement initiatives associated with the QA Microbiology Laboratory. • Makes and records observations and calculations; collects and prepares data for evaluation. • Performs technical and recordkeeping duties in conformance with company, regulatory policies and standards to ensure quality and accura...
Microbiologist-I Raritan, NJ	• Perform lab investigations and be an active participant in the problem solving. • Develop, write, and revise standard operating procedures in addition to generate study protocols and complete reports. • Disinfectant efficacy studies and be able to perform this testing with some guidance...
Pharmacovigilance Scientist HORSHAM, PA	• PV Scientist assists and supports the medical and scientific functions within safety evaluations for assigned products. • Such tasks include preparation and coordination of reviews of individual case safety reports as well as aggregate safety data. • Also support Risk Management Plans by serving as a coordinator for the acquisition and preparation of data for review from multiple sources. • Collect, and/or organize the data collected as part of Pharmacovigilance plan, RMP, product recall...
Process Operator MALVERN, PA	Process Operator • Perform newly developed and routine process operations related to the manufacture of chemical and pharmaceutical products • Weigh, mix, and formulate drugs and chemicals in accordance with current GMP • Accurately document all work performed as required • Maintain proper housekeeping of the work area and uphold a safe operating environment • Knowledge of GMP, GLP, FDA and OSHA standards may also be required ...
Procurement Manager Wilmington, DE	• Procurement, Supplier Leading project level procurement/outsourcing activities across functions and globally for lab procurement activity and work with CROs as assigned . • Leading the evaluation and selection of external vendors, using recognized criteria, including audits and feedback from previously conducted projects. • Lead and support the scope and commercial aspects of the external delivery solution (Procurement) for Drug Projects, managing a portfolio of external partners and provid...
Product Complaint Process Consultant Stamford, CT	• Evaluate existing product complaint processes • Assist the team in making recommendations to improve the effectiveness and efficiency of the product complaint process • Formulate and identify process improvements to meet changing product complaint volumes • Benchmark product complaint processes against those used by other companies and meeting regulatory expectations Deliverables include: • Identification of complexities in the existing process that can be modified. • Identificat...
Product Complaint Specialist West Irvine, CA	· Assist customers via phone and virtual based applications in technical and or clinical peer-to-peer support. · Liaise with field engineering teams to ensure customers on site support needs and requirements are met in accordance with FDA/GMP guidelines. · Assure all customer interactions are documented within the applicable documentation systems. · Maintain the quality process associated with product complaint handling, procedures and controls to ensure all c...
Product Safety Manager Wilmington, DE	• Serve as a safety, regulatory, and clinical resource for the monitoring and reporting of aggregate safety data for investigational and marketed products. • Draft sections of documents such as Safety Evaluation Review Meeting [SERM] Discussion Documents, Position Papers, Periodic Safety Update Reports [PSURs], responses to regulatory queries and marketing company queries; and providing safety surveillance reports, case listings, and other data necessary to maintain accurate safety profiles of ...
Project Manager Wilmington, DE	· Handling projects coordination between multiple vendors. · Managing projects to integrate disparate data feeds between internal/external systems....
Publications Coordinator-Risk Management & Epidemiology Stamford, CT	· Develop, write, review, edit, and submit scientific abstracts and publications for ongoing and completed studies within the Risk Management and Epidemiology department. · The studies include post-marketing epidemiologic studies to assess multiple measures of opioid abuse, prescribing practices of opioid analgesics, pediatric opioid use characterization, REMS assessment studies, post-marketing epidemiologic studies to assess safety, and methodology studies to validate outcome me...
QA Specialist Totowa, NJ	• Coordination of Complaint Management for the 3rd Party Complaints life cycle • Perform reviews of pertinent batch documentation from Purdue third party suppliers for completeness and accuracy. • Facilitates any applicable corrections with Third Party Suppliers to support batch disposition and ensure cGMP compliance. • Collates APR element data and summarizes in reports for all Purdue 3rd party manufactured products. • Acts as liaison between Third party Suppliers and Purdue for documen...
Quality Assurance Specialist Totowa, NJ	• The QA Specialist is responsible for supporting the Supplier Quality Assurance Department with the Quality Systems associated with External production of labeled products. • Working with the Manager of the department, the individual will be the Q.A. representative for all functions associated with, Customer Complaint Investigations, Batch Record Review, Annual Product Review (APR), and Documentation Management. • Coordination of Complaint Management for the 3rd Party Complaints life cycl...
Regulatory Affairs Manager 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...
Regulatory Affairs Manager Princeton, NJ	•Compiling, preparing, and reviewing submission documents from all functions including clinical, nonclinical and CMC. •Submission and maintenance of INDs, DMFs, NDAs, and BLAs to the FDA, and other global regulatory authorities as requested. •Submitting routine submissions with minimal supervision. •Provides regulatory strategic input and expertise based on regulatory guidance and experience to global project team on assigned project(s) •Prepares routine submissions such as investigator ...
Regulatory Affairs Specialist Jacksonville, FL	• Reviews, analyzes, and evaluates global registration requirements. (25%) • Assists project teams with identification of data requirements and coordinates the collection of data and documents to meet global registration requirements. (25%) • Maintains a current and accurate EC Technical File for the company’s products. Prepares and submits registration documents and periodic reports to FDA and other ministries of health. (20%) • Conducts and documents assessments of proposed change requ...
Regulatory Affairs Specialist SOMERVILLE, NJ	Regulatory Affairs Specialist • Write / compile US (PMA) & EU (Design Dossier) submissions to support Class III surgical synthetic sealant and hemostat products • Also, gather regulatory intelligence regarding various proposed design changes • Composing submission body based on predefined template • Interpreting and summarizing various study reports • Updating Essential Requirements Checklists • Conducting various short-term regulatory intelligence tasks • Requires 1-2 years Device ...
Regulatory Affairs Specialist 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...
Regulatory Affairs Specialist Jacksonville, FL	• Reviews, analyzes and evaluates worldwide regulatory registration requirements for new contact lens products • Coordinates global registration activities including preparation of submission documents in support of 510(k)’s, PMA/Supplements and Annual Reports • Reviews and updates the Technical Files in support of CE Marking of product for the European Union • Analyzes the impact of modifications to manufacturing, product and packaging to registration status of approved product and determine...
Regulatory Compliance Advisor Wilmington, DE	· Senior compliance professional operating in a global cross functional environment providing compliance advice to global teams, developing global audit programs and executing routine and complex global audits, independently with minimal supervision. · Assure that appropriate risk assessment, advice, and initial assessment of new and relevant regulations that impacts on Clinical Development are appropriately encompassed in functional and quality assurance procedures. · ...
Regulatory Labeling Associate Raynham, MA	• Support new product Regulatory associates with writing and compiling submissions as appropriate • Support International Regulatory associates with country requests and documentation • Document all submissions within Regulatory Tracking Database and ensure all submissions have been documented • File all submissions and review for any missing documentation • Communicate effectively at all levels within Regulatory as well as cross functionally with departments such as R&D, Quality, Purcha...
Regulatory Publications Associate Wilmington, DE	· Manage assigned regulatory status information for assigned markets. · Effectively communicate submission format requirements to the submission team. · Collect necessary information and requirements from the submission team. · Compiling, and publishing regulatory submissions in accordance with current standards. · Pursuing agreed tools....
Regulatory Technical Writer Jacksonville, FL	• Research, write and edit (pre)clinical reports, regulatory submissions, scientific publications, and/or technical business submissions. • Summarize data from (pre)clinical studies, develop cross-functional working relationships across internal Clinical, Regulatory and Pre-Clinical Development groups. • Summarize preclinical reports and summaries • Write, edit regulatory compliance documents (i.e.Risk Management Reports in compliance with ISO 14971) • ...
Research Associate San Diego, CA	· Responsible for cell-free and cell-based in vitro assays · Develop compound screening and analysis of ligand binding using radioligand displacement or time-resolved fluorescence methods · Analysis of cell responses using second messenger, gene reporter and cytokine release readouts. ...
Research Associate Spring House, PA	• Laboratory work related to the dosing of rodents and larger animals and sampling of blood and tissues. • Validation of experimental methods for the determination of pharmacokinetic properties of novel molecules coming from various research targets through in vivo experimentation. • Studies will involve pharmacokintic analysis, pharmacokinetic/pharmacodynamic studies, tissue distribution studies and mechanicstic studies to understand clearance or other parameters. • Standard and specialty ...
Research Associate 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). ...
Research Associate 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. ...
Research Associate San Francisco, CA	Research Associate • Responsible for cGMP testing of drug or adjuvant substance and product • Ensure documentation and communication of laboratory activities and results in a clear and timely manner, consistent with cGMPs, SOPs, Policies and other applicable regulatory guidance • Analyze and review test results, perform stability and other studies to support drug development • Investigate and resolve analytical or documentation problems • Write validation protocol, technical reports and...
Research Associate 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. ...
Research Engineer WARSAW, IN	• Work with a small team to scale-up a laboratory process for coating orthopaedic implants with Calcium Phosphate coatings. • Follow laboratory procedures and safety guidelines • Maintain detailed laboratory notebooks, and prepare technical reports as needed. ...
Safety Operations Scientist 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...
Sales Reporting Analyst Stamford, CT	• Responsible for multiple Sales Operations data validation deliverables, data management, and projects. • Responsible for validating several weekly and monthly data feeds and sales reports. • Deliver accurate and timely sales reports to the Field Force and to Sales Management. • Research and resolve data problems and field force inquiries. • Assist with managing several databases including the state and territory assignments for the Managed care field force. • Facilitate Field Force an...
SAP LSO Training Consultant 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...
Scientist 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 ...
Scientist Jacksonville, FL	Scientist • Perform complex background research, including, but not limited to, excipient and ingredient selection, active ingredient evaluation, small-scale experiments, intermediate scale and scale-up batch manufacture, evaluation of stability data • Assist in the testing of new technologies that can be used to develop new products • Evaluate complex technical issues to introduce new concepts, products, equipment or processes to develop new applications. • Analyze data from various so...
Scientist LOS ANGELES, CA	Scientist • 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, 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 lab scale batching, stability, project management, and excellent technical writing for reporting. ...
Scientist Radnor, PA	Scientist Profiling of purified soluble proteins in a variety of cell-based assays and analysis of data • Mammalian cell culture and aseptic technique • Ability to manage workload, coordinate in vitro assays, and prioritize tasks • Demonstration of oral, written, and interpersonal skills, including the ability to document and effectively communicate interpretation of data and results • Ability to work independently yet function within a larger research team as a strong, interactive team pla...
Scientist SKILLMAN, NJ	• Assist in the development of topical cosmetic/skin care formulations (eg. emulsions, gels, surfactants) • Preparation of lab scale batches to generate information to support selection of formulation components and manufacturing processes • Perform scheduled stability evaluations such as pH, viscosity and appearance • Order and maintain laboratory chemical supplies • Must be able to work under GMP guidelines and have strong documentation skills. ...
Scientist Princeton, NJ	Responsibilities • Primary duties will include assay development and validation • Designs, conducts and interprets biological experiments to support development programs and identifies biological pathways and agent • Analysis of biological samples from a variety of species • Investigates the growth and characteristics of microscopic organisms such as bacteria, algae and fungi. • This position requires a BA/BS with 4-6 years of experience or an MS degree with 2-4 years in the biological sc...
Scientist Lab Support MORRIS PLAINS, NJ	• Responsible for preparation of liquid and solid microbiological media, autoclaving and disposing of biohazardous waste and dishwashing of laboratory glassware • Other routine duties will include calibration of spiral platers and balances • Changing gas tanks on anaerobe chambers, maintenance and organization of stock supplies • Approximately 20% of work will entail basic microbiological lab activities including dilution and plating of samples, preparation of specialized plates used in assay...
Scientist/Chemist SKILLMAN, NJ	• Provide technical support for raw material qualification • Prepare lab batches of semi-solid and liquid products • Perform stability studies and test pH, viscosity, and other commonly tested attributes of semi-solid products • Coordinate with other functions to evaluate the impact of raw material change; manage multiple projects and able to meet project timeline ...
Security Analyst Wilmington, DE	· Information Security Programme (ISP) · Design, develop, and implement revised and enhanced information security capabilities to allow company to grant the right access to the right individual or partner. · Expand its effective and secure partnerships with third parties · Ensure that its security policies and practices are enforced and obeyed · Compliance Monitoring · Identity & Access Management · Information Assets Rights Manageme...
Senior Medical Communications Scientist Wilmington, DE	· Medical Communication Scientists are experts in the creation and exploitation of clinical/regulatory information that meets customer needs and supports robust internal and external decision-making. · Working from the end of Phase II onward, they lead the authoring of clinical regulatory documents for label-focused submissions (e.g., Common Technical Documents for NDA and MAA applications). · Work as part of clinical project teams to provide communications support, gu...
Senior Pharmacovigilance Safety Scientist Fort Washington, PA	• Create post-marketing safety datasets on a scheduled basis, i.e., daily, monthly, and quarterly. • The extraction of post-marketing safety data from internal and external safety databases; the combination of source data into analysis datasets; the categorization, coding, parsing. • Text searching query execution and other actions needed to enable scrutiny of large amounts of data; and contribution to writing of safety surveillance reports and procedures. • Independently execute epidemiolo...
Senior Product Safety Scientist FORT WASHINGTON, PA	Senior Product Safety Scientist • Responsibility and accountability for creating post-marketing safety datasets, performing epidemiological analyses, and contributing to the writing of safety surveillance reports for a wide range of consumer and personal products • Work closely collaboration with surveillance physicians who will provide the complementary clinical review and medical assessment of these reports; with safety informatics and analytics leadership to test and implement enhanced su...
Senior Project Manager Wilmington, DE	• Project Manager manages the program delivery for the HR outsourcing program. • The role has oversight of the program ensuring each element of the projects is on-time, on-budget and in adherence with quality and compliance standards. • The role has responsibility to coordinate with a global team items such as UAT planning, knowledge transfer workshops, cutover process and key user identification and training. • This wave of implementation includes all SET areas across Canada and US includi...
Senior UNIX Systems Administrator Waltham, MA	· This position will be a member of the team providing system administration for Unix/Linux servers and the WebLogic hosting platform · Provide support to customers and project teams for the development, implementation, and maintenance of standard architectural components ...
Serologist 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...
Sr. Assoc Scientist Cranbury, NJ	• Synthesis of compounds for submission for biological screening including purification, characterization, and assessment of purity, and upkeep of all necessary notebooks and records related to these preparations. • Provide write-ups for patents, publications or presentation as required • Organic synthesis, analysis of reaction mixtures and compounds, purification of organic compounds • Use of instrument such as ISCO, NMR. L/C/MS • Organic synthesis ...
Sr. Clinical Study Manager (SR. CMS) Stamford, CT	• Organize and facilitate the overall planning, coordination, tracking, and general performance of clinical studies that support the Clinical Development Plan. • Ensure clinical study quality/consistency of performance and in conjunction with the Clinical Leader and all other Team members is responsible for overall timeline adherence and performance against plan of the clinical study. • A critical component of the position is the peer management and/or support of coordination with contract...
Sr. Clinical Trial Specialist 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...
Sr. Manager Global Pharmacovigilance San Francisco, CA	· Ensure the consistency of safety-related processes, training, and system maintenance within Global Pharmacovigilance and Risk Management (GPRM). · Establish and maintain a quality and compliance framework for inspection readiness and regulatory compliance with drug safety reporting requirements across the Alzheimer Immunotherapy Program Alliance. · Track, report compliance, and implements appropriate corrective actions if needed. · Ensure all employees invol...
Sr. Manager Global Pharmacovigilance San Francisco, CA	· Ensure the consistency of safety-related processes, training and system maintenance within Global Pharmacovigilance and Risk Management (GPRM). · Establish and maintain a quality and compliance framework for inspection readiness and regulatory compliance with drug safety reporting requirements across the Alzheimer Immunotherapy Program Alliance. · Track and report compliance, and implement appropriate corrective actions if needed. · Ensure that all employees...
Sr. Product Safety Scientist Horsham, PA	• Responsible for the analysis of safety surveillance observations or the response to safety inquiries from internal and external authorities using post-marketing databases, the medical literature and exposure information for a wide range of OTC and Personal Consumer products • Report analysis results in support of signal detection and triage, health hazard / risk evaluations, risk management plans, regulatory submissions, label justification, and the assessment of safety profiles for all produ...
Stability Evaluator Titusville, NJ	• Manage the GPSG stability program. • Ensure all drug product GMP stability commitments are met by interacting with manufacturing sites and the stability laboratory. • Write change requests, stability protocols and SOPs to ensure all stability commitments are met and program is managed according to current GMP guidelines. • Use LIMS system to schedule and coordinate all stability sample pulls and studies to ensure samples are placed into the program and pulled at the appropriate time. •...
Staff Scientist Raritan, NJ	• Support operating companies 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 validations appropriate to the stage of the project to support R&D and marketed products. • Te...
Statistician Jacksonville, FL	• Perform data management and analysis support (engineering function) to support the Real Time/Predictive Quality initiative. • Work closely with causal analysis and process engineering disciplines in the development and application of causal analysis tools to collapse variation and establish root cause relationships between process, equipment and material variables with product attributes. ...
Statistician San Francisco, CA	• Contract statistician will provide support to the study lead statisticians with data checking, QC, display specification, and programming. • Provide statistical support to various BLA preparation activities as needed ranging from analysis definition, communication of results to the internal team and interfacing with programming team to prepare biometrics deliverables for the BLA...
Statistician Stamford, CT	• Statistical design and analysis of Phase 1 studies • Communicate with CRO statisticians in planning and reviewing Phase 1 statistical analysis • Interact closely with Clinical Pharmacology colleagues in order to meet tight project deliverables Collaborates and interacts with the clinical/medical staff utilizing technical knowledge and experience in the design, development, analysis, and reporting of Phase I clinical studies • Provides input into protocol development and review • Prepares...
Statistician RARITAN, NJ	5 years of pharmaceutical experience at Ph.D. level (or 8 years at MS level ) in biostatistics, statistics and epidemiology • Excellent communication skills (verbal and written) • Good team player • Advanced level in SAS but not looking for a SAS programmer. Looking for a senior level statistician who is advanced in SAS programming. • Extensive experiences in phase III/IV trials, in particular, CV trials, for example familiar with statistical analysis plan, clinical study report, database...
Statistician Princeton, NJ	Statistician • Write Statistical Analyses Plans and SAS programming plans • Perform SAS programming to implement Statistical Analyses Plans and SAS programming plans • Create a statistical study report including all summary tables, data listings, statistical analyses and results • Providing written interpretation of statistical analyses MS with major in Biostatistics, or statistics with coursework in medical or biological science • Experience in the medical device or pharmaceutical industry...
Statistician TITUSVILLE, NJ	• Applies mathematical knowledge to design surveys and experiments • Collects, processes and analyzes data and interprets results • Conducts statistical analysis of clinical trial data for reports and submissions to World-Wide Health Authorities. • Uses SAS programming to produce tables, listings and graphs for use in clinical study reports. • Interacts with statistical, programming and clinical team members to achieve product team goals. • Requires 3+ years exp. MS, PhD in Statistics ...
Systems Support Analyst Wilmington, DE	· Provide clinical supplies enabling support in the areas of Good Manufacturing Practice (GMP), Quality & Compliance, and Supply Chain management. · Contribute to R&D Supply Chain through continued quality improvement and risk management as applied to clinical supplies procedures, documentation, and administrative requirements. · Provide professional business administration support and guidance to promote an efficient Pharmaceutical Development Function. · The ...
Technical Writer 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...
Validation Scientist 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...
Validation Technician Los Angeles, CA	• Work on the process validation and cleaning validation teams responsible for supporting the document preparation and execution of validations in a semi solids manufacturing environment....
Validation Technician 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. ...
Writer Production Proofreader Skillman, NJ	• Responsible for the review of labeling, instructions for use and printer proofs for accuracy, completeness, consistency, and content. • Compare artwork against source documents and/or previous artwork versions, if applicable, and call out new copy. • Review artwork for spelling, punctuation, hyphenation, grammar, and syntax. • Compare component artwork for consistency in message across Product line. • Able to gather appropriate information through ...

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