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We are hiring a Medidata Rave Clinical Programmer to work onsite in the Central New Jersey area:      Clinical Programming support of Medical Affairs studies to be initiated in upcoming months.  Expertise in all facets of EDC setup, UAT (in particular RAVE) a must.  Experience in oversight of CRO a plus.   Skills/Knowledge Required: • BS/BA degree or equivalent in a relevant scientific discipline with a minimum of five years experience • Advanced knowledge of clinical database design is a must ...

 TrueBridge Resources, a North Highland Company one of the Nation’s fastest growing staffing and recruiting firms, works with clients to fill Contract, Contract-to-Hire, and Direct Hire opportunities within Management Consulting, IT, Accounting/Finance, Engineering, Human Resources and Marketing. Bridge your career to the next level, and experience the ultimate employment experience for yourself.   TrueBridge Resources is seeking a Technical Writer for a long-term contract position in Middlesex ...

Contact Kristine at 815-756-1221 for more information Qualifications: - MS/PhD in Toxicology, Science, Nutrition - 7-10 years food ingredient regulatory experience - Food, beverage, dietary supplement or personal care experience required - Familiar with U.S. FDA and other international regulatory agencies - Extensive toxicity knowledge - Knowledge of corporate resources to support objectives - Ability to interface with people at all levels - Demonstrated written and oral communication skills - ...

Clinical Programming support of Medical Affairs studies to be initiated in upcoming months. Expertise in all facets of EDC setup, UAT (in particular RAVE) a must. Experience in oversight of CRO a plus.   Skills/Knowledge Required: • BS/BA degree or equivalent in a relevant scientific discipline with a minimum of five years experience • Advanced knowledge of clinical database design is a must (Inform, Oracle Clinical or other systems). • Experience managing clinical programmers • Participation in ...

 Responsible for supporting, under the leadership of the Global Trial Leader (GTL), all aspects of clinical trial(s) (phase II through lifecycle management) as assigned. -Support GTL in ensuring all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards: development of study tools and guidelines to ensure consistency in study implementation and management at site, management of clinical study material, implementation of issue resolution ...

Cranford, NJ – Supervisor Project Management BASIC FUNCTION: Ensures contracted services in relation to clinical trial management are carried out effectively by the Project Managers and Associate Project Managers.  Provides leadership to the team in support of overall Project Management department objectives. SCOPE OF SUPERVISION: This position is responsible for the direct supervision of 3 – 15  employees, requires minimal supervision and reports to the Associate Director Operations or Manager ...

Cranford, NJ – Sr. PM BASIC FUNCTION: Coordinates and implements Clinical Trials projects.  Manages daily activities of established clinical trials. SCOPE OF SUPERVISION: N/A PRINCIPAL FUNCTIONAL RESPONSIBILITIES: Accountable for successful delivery of assigned clinical trials projects. Ensures that study specifications and deliverables are consistent with corporate and client expectations. Ensures that scope and timelines are clearly documented and agreed, according to client, protocol and internal ...

Project Manager – Cranford, NJ BASIC FUNCTION: Coordinates and implements Clinical Trials projects.  Manages daily activities of established clinical trials. SCOPE OF SUPERVISION: N/A PRINCIPAL FUNCTIONAL RESPONSIBILITIES: Accountable for successful delivery of assigned clinical trials projects. Ensures that study specifications and deliverables are consistent with corporate and client expectations. Ensures that scope and timelines are clearly documented and agreed, according to client, protocol and ...

************This is a right to hire position. between 6-18 month range******************* Summary: Under limited supervision, responsible for purchasing/procuring Engineering related goods and services. The Engineering related goods and services will entail process equipment, machinery, and manufacturing equipment. Three (3) to eight (8) years of purchasing experience in pharmaceutical or biotech. Looking for Type-A candidates who show progression in their experience. Longevity and job stability is ...

Our client, a premier Pharmaceutical company, is seeking a Manager, Project Sourcing for a 6 month assignment.  Pay rate is up to $55 an hour plus benefits. This role will be supporting sourcing project activity within indirect areas, such as management consulting, R&D sourcing, travel sourcing and meetings management. CRITICAL REQUIREMENTS - MUST HAVE 1. Sourcing and procurement experience (indirect, NOT direct) 2. Drafting and sending out RFPs 3. Experience managing stakeholders and their ...

 REQUIRED:   Strategic Sourcing, clinical development experience, vendor assessment, selection, management Fluent English in Oral and written Ideal background:  Strategic Sourcing, clinical development experience, vendor assessment, selection, management At least 3 years international experience in Drug Development in Pharmaceutical Industry or with a vendor/provider Experience in outsourcing, contracting, sourcing, of clinical services; from Vendor/Provider & specific experience in proposals, ...

This medium-sized global ingredient supplier is seeking an experienced nutraceutical sales professional who wants to be part of the growth and success this company has achieved with their high integrity science-backed natural ingredients.  This New position requires senior leadership experience and a successful track record for leading the vision and direction of the sales, marketing and customer service functions of a company.   Branded and commodity ingredient sales leadership, team development, ...

This new position was created for a science-oriented professional who can lead and manage the business development efforts of specially selected branded nutraceutical ingredients.     This 5+ year experienced ingredient professional will define and direct a product’s vision and industry application plus work with the sales and marketing team to leverage its introduction and impact in the market. Other responsibilities include:   Drive product development of specially selected branded ...

 Hello,   My name is Chris and I represent The Fountain Group.  We are a national staffing firm and are currently seeking an Statistical Programmer for a prominent client of ours.  This position is located in Florham Park, NJ. Details for the positions are as follows:   Job Description:   Provide statistical programming support and validation and help set specifications of anlysis datasets, pooled datasets, statistical tables, summaries, figures and listing for Phase II-IV clinical trials. Employ ...

This position will be best suited to someone with a Software Test Engineer background. The best fit for this position will have all of the below qualifications: 1. Experience in writing test protocols 2. Experience in following and executing test protocol meticulously 3. Conduct white box testing 4. Conduct black box testing 5. Knowledge of testing practices 6. Experience with defect tracking and management systems 7. Experience with heuristic testing 8. Experience in a process or regulated ...

This position is for a Project Manager. Candidates should have 3+ years of experience working as a project manager preferably in the Medical device industry. Candidates must have: a software background. Experience working with Microsoft Project, Word, Excel, and Power Point. Must have good oral and written communication skills. Must be able to work in a colaborative environment. It is preferred that Candidates have previous experience working in an FDA controlled work place. 

 Provide statistical programming support and validation and help set specifications of anlysis datasets, pooled datasets, statistical tables, summaries, figures and listing for Phase II-IV clinical trials. Employ standardized programs where applicable. Provide input into planning documents such as protocol, validation plan, and report analysis plan. Provide outputs for clinical study reports, integrated summaries and electronic submissions. Help respond to health authority inquiries for submitted ...

 Our Global Client is a large manufacturing company and they are looking for some talented QC Chemists to provide the following: Great Opportunity ! Perform various QC analyses on lab samples at mfg plants; Ensure compliance to cGMP’s and Safety & Health Programs.  Analyze lab samples (raw material, in-process, finished product, stability, etc.) Participate in lab investigations when required.  Initiate and takes the lead role in Out-of-Specifications and Analytical Deviations of QC Lab ...

Experience And Required Skills : Qualified candidates: -Ph.D.in Statistics or related discipline and at least 5-10 years of related experience in the biotechnology, pharmaceutical or health related industry -Significant interaction with both FDA and EMEA, history of successful project and people management, and expertise in multiple therapeutic areas -Exercises judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and ...

Hello,   My name is Mike Rice and I represent The Fountain Group.  We are a national staffing firm and are currently seeking a Lead Trainer for a prominent client of ours.  This position is located in Titusville, NJ. Details for the positions are as follows:   Job Description:Responsible for the development and implementation of a training plan for a clinical site contracting workflow and document management system including the development of the training materials and  comprehensive user manual. ...

Qualifications:  5+ years’ experience in SAS Programming with large administrative claims database experience required (i.e., MarketScan or other health plan administrative claims data), Master’s in Statistics is preferred, knowledge of selected study design and modeling (linear and non-linear).  Infectious Disease or COPD experience a plus.  Conducting internal data analysis supporting Health Economics and Outcomes Research function.

 Our Large Global Pharmaceutical Client is looking for a Director of Quality to do the following: Ensures corporate compliance to Regulatory Agency requirements (i.e., FDA, EU, DEA, etc.) from a Quality perspective throughout the clients manufacturing plants within his oversight (and to some degree regarding contract manufacturing companies where this position acts as Quality liaison interact for limited third party cGMP oversight).  Head QA/QC Designee for US Operations within the Corporate CQMS ...

Serves as Global Program/Brand Team (GPT/GBT) scientific safety leader. Responsible for safety issue management from formation of GPT/GBT through Life Cycle Management (post-approval). Develops and is responsible for key internal safety documents from the formation of the GPT/GBT through Life Cycle Management. Reviews these documents regularly and updates as required (e.g. when significant new information received). Ensures that these, and all other pro­ject-related safety documents, are consistent ...

  Our Global Manufacturing Client  is looking to hire a Full Time Maintenance Supervisor to do the following. Maintenance Supervisor Associate Degree in Engineering or Technology with a concentration in Mechanical or Electrical – Bachelors in Engineering is strongly preferred. 7-10 years in maintenance of pharmaceutical machinery in oral solid dosage plant. Supervises Team Leads and Mechanics. JOB PROFILE: -This position is responsible for maintaining all manufacturing and packaging machines in good ...

  Currently seeking 2 Lead Clinical Data Managers for a permanent opportunity with a leader in the pharmaceutical industry.  Ideally looking for individuals to start as soon as possible.   Responsibilities:   Will lead & manage project activities at the study level for clinical data management and ensure coordination between teams.  Will act as single point of contact for all data management deliverables during study set-up, conduct, and close out phases.   Responsible for the creation/review ...

  Our Global Manufacturing Company is looking for a Facilities Supervisor to do the following. This is a full time position.   ·         Ensures compliance to government regulations and operation of facility systems, including security, steam, compressed air, city water, sewer, electrical and HVAC systems.     ·         Ensures facilities (buildings) are in good repair (e.g. cracks in walls filled in) and initiates and supervises repair work.  Ensures safe and secure parking area for our employees ...

Our client, a growing Pharmaceutical company in the Lawrenceville area, is seeking a Promotional Review Editor for a 3+ month assignment.  Pay rate is up to $50 an hour plus benefits. Manages the delivery of a full range of editorial services, including medical editing, copy editing, proofreading, and fact verification of pharmaceutical marketing materials, internal and external presentations, and corporate communications, from initial Promotional Review Board (PRB) submission through final approval ...

My client, a growing publicly traded pharmaceutical company, is seeking a Finance an Contracts Associate for its headquarters in New Jersey. Job Description Finance and Contracts Associates (FCAs) coordinate various contracts for multiple clients with end-to-end responsibility of specific customer accounts [from contract creation to payment collection].  FCAs communicate directly with clients, as well as internal cross functional groups, to develop, amend, review, and analyze contracts. FCAs help ...

$5000 Hiring Incentive for qualified candidates! Experienced Clinical Research Associates (CRA) are needed US Nationwide!  Currently we are in urgent need for home-based CRAs with early clinical experience in oncology, respiratory, renal/hepatic, and general med.   If you have at least two years on site monitoring experience, authorized to work in the US for any employer and willing to travel at least 80% - I invite you to read our latest job need by following the link below.   Covance ...

 INTERVIEW/HIRE IMMEDIATELY  My client is actively looking to add to their Clinical Operations team with their Headquarters located in central New Jersey (local candidates only).  This is an exciting time to join the Company, as they are working towards their 1st approved product.  A great opportunity for someone that wants to grow with a company, take-on lots of responsibility, and learn from industry professionals. If you are a CRA/Lead CRA and possess the following skill-set, please contact 3D ...

Job Ref: #1637 Relocation: Yes Location: Parsippany NJ Salary: Dependent on candidate. Summary: Growing environmental consulting firm looking for a regulatory compliance specialist with 10+ Years of experience. We are seeking a professional with project experience to ensure environmental permitting, periodic reporting, training, and other compliance obligations relevant to a specific site are met on a consistent and timely basis. This is a leadership position with technical ...

Responsibilities: • Operationally supports and executes the imaging plans outlined in Oncology study protocols including supply of standard language, management of imaging CROs • Preparation of scope of work, imaging charters, and support imaging data transfer and reconciliation. Skills • Familiarity with a broad range of imaging techniques. • Preferred experience in CRO management or CRO environment, and an understanding of Imaging CRO capabilities. • Basic knowledge of clinical ...

Description: The Clinical Scientist is responsible for the scientific strategy of assigned clinical trials for protocol development, ensuring the review/reporting of quality trial data, and study reporting/publishing in compliance with client’s processes, GCP/ICH and regulatory requirements. Supports program level activities as assigned. Program/project level responsibilities: • Support the development of operational plans for clinical deliverables, effectively applying principles of design ...

Job Description: Support the operational execution of the clinical study strategies related to biomarker and pharmacokinetic assessments in oncology protocols, in compliance with client’s processes and regulatory requirements and in collaboration with Oncology Clinical Teams. Responsibilities: • Sample tracking for biomarker and pharmacokinetic samples from clinical site to analytical laboratory. • Setting up the laboratory procedures, being the primary point of contact and providing ongoing ...

Responsibilities: • Leads Global Medical Affairs strategy and implementation for specified compound(s). • Acts as medical representative on the Global Brand Team, Global Project Team, and International Clinical Team • Provides clinical leadership and accountable for global medical affairs strategy and life cycle management • Acts as clinical lead for Scientific Communication deliverables and publications (with Scientific Affairs group), brand-related input into therapeutic area and disease area ...

Responsibilities: • Working with Clinical Science/Business Units and a Standard Governance Board, the successful candidate will transform data collection requirements into data models. • Provide input to OC Global Librarian team in developing and maintaining standard objects for OC standard Global Library. • Work with the Clinical Science Units to understand the data requirements for their reporting, submission and collection • Model the data collection , storage, transformation & submission ...

Our client is a cutting-edge medical communications company whose digital deliverables are mobile, tablet and desktop programs for pharmaceutical companies.   They are seeking a Business Development Manager who has an existing pharma contacts network and who will contact potential clients, set up and make presentations at client meetings, and grow the client base/company revenue.  Required is a BA/BS, up to 8 years of Business Development experience, experience in cold-calling and presentations and ...

 Job Responsibilities: • Guide planning, evaluation and interpretation of early clinical development studies with the goal of influencing key drug development, regulatory and therapeutic decisions. • Proactively initiate and conduct clinical trial simulations and  pharmacometric modeling to support decision making and quantitative exploration of pharmacological principles. • Proactively implement translational medicine strategies and statistical methods into area of responsibility. ...

Bachelor’s Degree in a technical discipline plus more than 10 years of applicable technical and/or management experience,Extensive experience with polyurethane rigid foam technology, processing, and applications, including production, formulating, and testing,Demonstrated ability to lead people, manage performance, and develop talent in technical organizations,Demonstrated strong communication skills for interacting with all levels of personnel, supporting department objectives and management ...

Seeking extensive clinical development experience to help guide discovery strategies and focus pre-clinical resources and efforts most effectively for big pharma research & development activities. Must be a strategic expert and savvy diplomat to work closely with global pharma CEO in the analysis, selection and internal promotion of drug development strategies from evidence-based medicine to sustainable therapeutic solutions. Requires MD-Ph.D, MD, or Ph.D and well rounded research executive with ...

Job Description: Assigns, oversees, and reviews the work of employees. Directs all phases of work, quality, service, and costs; and performs tests or assays as required. Skill Requirements: Candidate must possess strong leadership skills and will direct activities in the laboratory within a managed hospital environment. Required competencies will include but not limited to the following: High level of efficiency in dealing with various levels in the organization, possesses high stress tolerance ...

Tasks/Responsibilities: - Manage department’s responsibilities with Trial Master Source- TMS (enter data in to the TMS system, interact with project owners to obtain the information needed for TMS, review that the standards of procedures for safety reporting are followed, respond to TMS queries and prepare data for registration of epi studies) - Support of Research effort to include but not limited to literature searching, literature review, drafting protocols, drafting other associated research ...

  We are looking for Sr. level candidates, this role can be remote or onsite based on experience.  Relocation is available!   Summary of role Oversee statistical aspects in the design and analysis of clinical trials, including project management, statistical analysis, report preparation, and advising other project statisticians Function as Biostatistics Project Leader for multiple protocols, projects, or NDA projects, including coordinating with other  divisions and ...

Our client, a leading Pharmaceutical services company needs Statistical Programmers (Fulltime/Perm) in Princeton, NJ.  ¨       Develop SAS programs for SDTM, ADaM, client-defined analysis datasets, Patient Profiles, Tables, Listings and Graphs in support of the Statistical Analysis Plan, posters, manuscripts, Integrated of Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) ¨       Demonstrate good problem solving skills, a proactive approach and a willingness to make decisions, seeking ...

Shall design and develop formulations of new transdermal products. Required Experience: *** Transdermal patch physical property testing and rheology testing *** Transdermal characterization: x-ray powder diffractometry (XRPD), differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), and isothermal microcalorimetry (ITMC) *** Knowledgeable of scale-up, tech transfer, and process optimization. *** Familiar with transdermal manufacturing unit operations and equipment such as ...

Shall design and develop dosage forms for metered dose inhalers, dry powder inhalers, nasal sprays, and nebulizers. Required Experience: *** Design of Experiments. *** Solid state characterization: HPLC, UV-VIS, FTIR, Raman, X-ray Powder Diffraction, thermal analysis. *** Aerosol and powder characterization: cascade impaction, moisture sorption isotherm, bulk density, surface area, particle size analysis. *** Knowledgeable of scale-up, tech transfer, and process optimization. *** Familiar ...

COMPOUNDERS NEEDED ASAP (CRANFORD AREA, NEW JERSEY) COMPOUNDERS NEEDED ASAP- 3RD SHIFT (OVERNIGHT) POSSIBLE 2ND SHIFT AVAILABLE. TEMP TO POSSIBLE PERMANENT POSITION EXCELLENT OPPORTUNITY POSITION SUMMARY Responsible for the accurate weighing, checking and mixing of specific chemical compounds for product formulations; the calibrating and monitoring of a variety of mixing machinery and the accurate documenting and maintaining of production logbooks and records. They're also required to follow ...

Mid-sized CRO seeking RCRA in TX. 4 year degree in life sciences with 2+ year on-site experience. Travel 75-85%. Resumes to [email removed]

Our client, a pharmaceutical company, is seeking a Contract Medical Affairs System Specialist for about a year.  The compensation is up to $45 an hour plus benefits. The Medical Affairs System Specialist: • Act as a Liaison between Medical Affairs (Field & In house), Field Force Automation, and other areas of IT, to support alignment and continuous process improvement for Medical Affairs Operations • Coordinates and compiles regular monthly reports ad hoc data as needed for metrics tracking • Assist ...

  Region to cover: NJ, NY, CT, and PA   CLINICAL RESEARCH ASSOCIATE   Job Key Duties and Responsibilities: This position is responsible for performing any/all of the following tasks and responsibilities, as well as any other tasks deemed appropriate by the Supervisor: · Monitor activities at assigned clinical study sites to assure adherence to ICH GCPs, local regulatory requirements, Standard Operating Procedures (SOPs), Standard Guidelines (SGs), Instruction Manuals (IMs), study ...