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Job Results: 34 Jobs
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| # |
Position
/ Job Type
/ Compensation
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Company |
Location |
Description |
Date Posted |
| 1 |
Informatica Support Analyst
FT-Direct Hire
$1.00 - $1.00
/Hour
|
Fladger and Associates, Inc |
Raritan NJ 08869 |
Informatica Support Analyst
Requirements:
To enhance Informatica Shared Services platform in both NA and EMEA on both Windows (NA & EMEA) and Linux (NA):
• Install and Configure PowerCenter 8.6.x on additional servers
• Configure LDAP for authentication, and join existing Enterprise grid
• Configure security (User/Groups, Roles, File system level) per security design
• Configure Informatica RTM (Reference Table Manager)
• Configure Metadata Manager services
• Configure Data Analy |
09/03/2010 |
| 2 |
Cognos Infrastructure Architect-Engineer
FT-Direct Hire
$1.00 - $1.00
/Hour
|
Fladger and Associates, Inc |
Raritan NJ 08869 |
Cognos Infrastructure Architect-Engineer
Requirements:
• This engneer will understand the recommendations given by ITS and Cognos Health assessment, will be able to test proposed solutions, plan and document for implementation and execute implementation. Assess after implementation
• Responsible for analysis, testing of proposed changed, providing a detailed impemantation documentation
• Lead cross functional teams including Engineering & Operations toward successful implementa |
09/03/2010 |
| 3 |
Pharmacovigilance Scientist
FT-Direct Hire
$1.00 - $1.00
/Hour
|
Fladger and Associates, Inc |
HORSHAM PA 19044 |
• 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 |
08/29/2010 |
| 4 |
Regulatory Publication Assoc
FT-Direct Hire
$30.00 - $33.00
/Hour
|
Fladger and Associates, Inc |
WIimington DE 19801 |
• Collect necessary information and requirements from the submission team.
• Contribute to the compilation and publishing of regulatory submissions in accordance with current standards and processes
• Ensure printing and distribution of regulatory submissions, paper and electronic, to all concerned markets, as required.
• With supervision, analyze submissions, track and record life-cycle information in accordance with standards.
|
08/29/2010 |
| 5 |
Chemist
FT-Direct Hire
$25.00 - $28.00
/Hour
|
Fladger and Associates, Inc |
WIimington DE 19801 |
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
|
08/29/2010 |
| 6 |
IS Services Delivery Consultant
FT-Direct Hire
$55.00 - $65.00
/Hour
|
Fladger and Associates, Inc |
WIimington DE 19801 |
• Ensure that external service providers are accurately measuring and reporting service level performance in line with the needs of contractual agreements.
• Ensure that external service providers are continuously, accurately measuring and invoicing against agreed and clearly understood and validated baseline forecasts.
• Ensure that any performance incentives models within contractual agreements are appropriately applied.
• Develop and ensure the effective deployment and operation of proces |
08/22/2010 |
| 7 |
Process Operator
FT-Direct Hire
$15.00 - $20.00
/Hour
|
Fladger and Associates, Inc |
MALVERN PA 19355 |
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
|
09/02/2010 |
| 8 |
TOXICOLOGY ASSOCIATE
FT-Direct Hire
$1.00 - $1.00
/Hour
|
Fladger and Associates, Inc |
Princeton NJ 08541 |
TOXICOLOGY ASSOCIATE
• Evaluating the safety of ingredients and formulations; preparing individual study reports and safety/risk assessment documents
• Conducting literature searches to identify supporting information determining appropriate preclinical testing requirements and study designs to support developmental projects
• Interpreting test results in preparation for submission to regulatory agencies
• Function as study monitor for preclinical studies at contract facilities
|
08/19/2010 |
| 9 |
Regulatory Affairs Specialist
FT-Direct Hire
$25.00 - $30.00
/Hour
|
Fladger and Associates, Inc |
Jacksonville FL 32256 |
• 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 |
08/19/2010 |
| 10 |
Formulation Chemist
FT-Direct Hire
$1.00 - $1.00
/Hour
|
Fladger and Associates, Inc |
LOS ANGELES CA 90045 |
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 |
09/02/2010 |
| 11 |
Statistician
FT-Direct Hire
$1.00 - $1.00
/Hour
|
Fladger and Associates, Inc |
RARITAN NJ 08869 |
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 |
09/02/2010 |
| 12 |
Medical Content Editor
FT-Direct Hire
$1.00 - $1.00
/Hour
|
Fladger and Associates, Inc |
HORSHAM PA 08541 |
Medical Content Editor
• The medical editor will apply subject matter expertise in support of large scientific content authoring effort
• The primary goal of this role is to provide medical review, copy-editing and proofreading services for medical content for various components of Medical Information websites
• Additionally, the editor will assist the project team in applying images, tables, citations, meta-data, etc. to the content within the provided technology as directed by the project l |
09/02/2010 |
| 13 |
Clinical Research Assoc. - CRA
FT-Direct Hire
$30.00 - $35.00
/Hour
|
Fladger and Associates, Inc |
Jacksonville FL 32256 |
Clinical Research Assoc. - CRA
• Monitors clinical study per ICH Guidelines and GCPs
• Maintains essential documents and other study-related documents
• Plans and develops simple study protocols/technical reports, CRFs and other study materials
• Assists in study implementation, which may include: investigator recruitment, site management, IRB liaison, Adverse Event management, Periodic Report generation, and/or supplier oversight
• Performs other related duties as assigned by manageme |
08/26/2010 |
| 14 |
Clinical Learning/Education Partner
FT-Direct Hire
$50.00 - $55.00
/Hour
|
Fladger and Associates, Inc |
WIimington DE 19801 |
• Determine learning needs to agreed strategy to achieve current and future business needs
• Design and manage medium-sized education programs that will drive improvements in business performance
• Work with internal and external Knowledge Experts to achieve desired program content
• Develop contracts for each learning program and agree with Partner Leads to ensure alignment with business objectives
• Develop metrics and conduct evaluation of learning programs and use these to determine impa |
08/26/2010 |
| 15 |
Clinical Safety Scientist
FT-Direct Hire
$50.00 - $60.00
/Hour
|
Fladger and Associates, Inc |
RARITAN NJ 08541 |
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
|
08/26/2010 |
| 16 |
Clinical Project Leader
FT-Direct Hire
|
Fladger and Associates, Inc |
RAYNHAM MA 02767 |
• Primary contact and initiator for all components of clinical program strategy and execution Mentors and coaches staff in the design and execution of clinical studies
• Develops protocols and clinical trial materials (consent, case report forms, recruitment materials, site tools)
• Develops and negotiates site budgets
• Reviews case report form completion guidelines, logic checks and data handling guidelines
• Lead Clinical Affairs developer of statistical analysis plans
• Respons |
08/22/2010 |
| 17 |
SAS Programmer
FT-Direct Hire
$1.00 - $1.00
/Hour
|
Fladger and Associates, Inc |
RARITAN NJ 08869 |
SAS Programmer
• Support the Sales Operations Department through in-depth analysis, knowledge, advice and recommendations in sales force information
• Development and/or analysis of customer segments, targeting, plan versus actual reporting, data mining, deployment scenarios, standard and ad-hoc reporting and business analysis
• Minimum 4 year degree, preferably in Statistics, Economics or Computer Science
• 2-3 years analyst experience required with good organizational skills, analytical a |
08/26/2010 |
| 18 |
Statistician
FT-Direct Hire
$1.00 - $1.00
/Hour
|
Fladger and Associates, Inc |
Princeton NJ 08541 |
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 |
08/26/2010 |
| 19 |
Drug Safety-Pharmacovigilance Scientist
FT-Direct Hire
$50.00 - $60.00
/Hour
|
Fladger and Associates, Inc |
Horsham PA 19044 |
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 |
08/12/2010 |
| 20 |
Project Physician- Medical Monitoring
FT-Direct Hire
$110.00 - $125.00
/Hour
|
Fladger and Associates, Inc |
RARITAN NJ 08869 |
• Responsible for medical monitoring/reporting and company safety officer activities
• Evaluates adverse events (pre and post-marketing) for relationship to treatment.
• Assists Regulatory Affairs in determining requirement for any corrective actions or health authority reporting.
• May act as a medical contact at the company for the Food and Drug Administration and other worldwide health authorities concerning clinical/medical issues
• Interprets, reports and prepares oral and written r |
09/02/2010 |
| 21 |
Clinical Research Scientist
FT-Direct Hire
$55.00 - $65.00
/Hour
|
Fladger and Associates, Inc |
RARITAN NJ 08869 |
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 |
08/19/2010 |
| 22 |
CLINICAL PUBLISHING LEAD
FT-Direct Hire
$1.00 - $1.00
/Hour
|
Fladger and Associates, Inc |
Wilmington DE 19801 |
• Delivers the US-specific publication plans
• Ensures that statements and conclusions in publications are supported by appropriate data
• Provides leadership of cross-functional US Product Publications Delivery Team charged with delivering the US Publication strategy and plan
• Consults and liaises with external authors on matters related to publications activities
• Identifies and manages publications agencies through the effective use of project management skills to ensure the delivery o |
08/19/2010 |
| 23 |
Outcomes Research Scientist
FT-Direct Hire
$55.00 - $65.00
/Hour
|
Fladger and Associates, Inc |
Wilmington DE 19801 |
• In-depth specialist knowledge of Health Economics and/or Outcomes Research and its application to pharmaceutical development at an international level.
• Comprehensive understanding of the pharmaceutical industry and regulatory requirements from a global perspective and product development processes at all life cycle stages.
• Knowledge of international healthcare systems and their changing needs for health economic and patient-reported outcomes information.
• Strong knowledge of l |
08/19/2010 |
| 24 |
Clinical Research Associate/CRA
FT-Direct Hire
$40.00 - $45.00
/Hour
|
Fladger and Associates, Inc |
RAYNHAM MA 02767 |
· 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 |
08/05/2010 |
| 25 |
Clinical Medical Affairs/MD
FT-Direct Hire
$1.00 - $1.00
/Hour
|
Fladger and Associates, Inc |
RARITAN NJ 08869 |
Clinical Medical Affairs/MD
• Responsible for strategy, development, management and implementation of clinical trials
• Develops and networks with key opinion leaders and customers to develop and implement clinical trials, participate in investigator selections, organization of investigator meetings, and writing of protocol documents for regulatory submissions
• Develops budgets, schedules, and performance standards for self and project. Develops and implements publications and communicatio |
08/26/2010 |
| 26 |
Medical Writer
FT-Direct Hire
$45.00 - $55.00
/Hour
|
Fladger and Associates, Inc |
HORSHAM PA 19044 |
• 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 |
08/05/2010 |
| 27 |
Scientist
FT-Direct Hire
$20.00 - $25.00
/Hour
|
Fladger and Associates, Inc |
Princeton NJ 08541 |
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 |
08/12/2010 |
| 28 |
Clinical Operations Manager
FT-Direct Hire
$1.00 - $1.00
/Hour
|
Fladger and Associates, Inc |
RARITAN NJ 08869 |
• 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 |
09/02/2010 |
| 29 |
Statistician
FT-Direct Hire
$50.00 - $65.00
/Hour
|
Fladger and Associates, Inc |
TITUSVILLE NJ 08560 |
• 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
|
09/02/2010 |
| 30 |
Clinical Research Assoc./Project Manager
FT-Direct Hire
$40.00 - $50.00
/Hour
|
Fladger and Associates, Inc |
CINCINNATI OH 45201 |
• Manage and develop project team.
• Supervise and evaluate assigned project staff activities and job performance.
• Provide continuous support of monitoring responsibilities.
• Develop protocol monitoring guidelines and other assorted project-specific training instructions.
• Act as principle liaison between sponsor, CRO (Clinical Research Organization) and investigator sites. Negotiate budgets and monitor investigator payments.
• Requires 8 years of clinical research experience, ty |
08/19/2010 |
| 31 |
Pharmacovigilance Physician
FT-Direct Hire
$1.00 - $1.00
/Hour
|
Fladger and Associates, Inc |
Princeton NJ 07950 |
yes
• Medical evaluation of adverse event reports, including but not limited to
all serious and expedited reports and all pregnancy reports
• Preparation of IND letters to investigators (SUA summaries)
• Provide medical guidance and opinions to drug safety associates, other physicians and scientific staff in the evaluation and follow-up of individual case safety reports
• Provide medical input for ad-hoc queries as requested
• Participate in signal detection efforts, e.g. strategy meetin |
08/12/2010 |
| 32 |
Labeling Manager
FT-Direct Hire
$65.00 - $80.00
/Hour
|
Fladger and Associates, Inc |
Collegeville PA 19426 |
• The Labeling manager is responsible for the facilitation and management of the end-to-end labeling processes for a pre- and post-marketed product/product family, over the length of the product(s) life cycle
• Responsible for the coordination of all related global and cross-functional activities related to the labeling process to meet established time lines.
• The Labeling manager will work in an XML environment and with a variety of software packages to create and maintain changes in labeli |
08/26/2010 |
| 33 |
Drug Safety Surveillance Scientist
FT-Direct Hire
$40.00 - $55.00
/Hour
|
Fladger and Associates, Inc |
Horsham PA 19044 |
Principal Responsibilities:
•Assist the SSP and Sr. SSS in identifying and evaluating new safety signals and trends by conducting systematic reviews of aggregate data with a focus on spontaneous adverse event reports. Prepare topic reviews and summary analysis reports of safety data, in consultation with the safety surveillance physicians in the group. Provide recommendations for further evaluation (65%)
•Participate as member of the matrix teams to address product specific safety issue |
08/05/2010 |
| 34 |
Medical/Drug Information Specialist
FT-Contract
$35.00 - $45.00
/Hour
|
Fladger and Associates, Inc |
Wilmington DE 19802 |
Major Responsibilities
- Manage all customer inquiries to successful resolution. Provide immediate resolution to inquiries at the point of contact.
- Effectively communicate messages, timely product information and/or specific offers to physicians, health care staff and/or consumers via outbound teleservice according to specific Information Center outbound initiatives.
- Escalate calls as appropriate.
- Follow and suggest improvements to AstraZeneca¿s policies in response to customer needs |
08/05/2010 |
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