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  1. Packaging Supervisor Pharmaceutical

     Our Global Manufacturing Company is looking for an experienced Packaging Supervisor to do the following:    ·         Support Annual Packaging volume of 40-60 million units.       Total headcount 10-15 employees Delegation of Responsibility: Raw Material and Shipping/ Receiving, and Inventory Team Leader assume responsibility in the absence of the position.  Job Profile:  ·         Ensure that the team is  engaged  o   Regularly recognize employees for notable achievements o   Maintain open door ...

  2. Dispensing Supervisor Pharmaceutical

    Our Global Manufacturing Client is looking for a Dispensing Supervisor to do the following.   Supports three New Jersey Manufacturing sites to:   · Ensures that all Warehouse department operations (Dispensing Raw Materials, Dispensing Packaging Materials, Shipping and Receiving and Inventory Control Management) abide by cGMP’s, FDA, DEA, OSHA and other governmental rules and regulations. · Ensure compliance to SOP’s, Guidelines and FDA regulations. · Ensures the coordination of process improvement ...

  3. Director, Clinical Cardiovascular

    POSITION                   The Director Clinical Development, Cardiovascular will report directly to the Vice President of CV/Met. and is responsible for the scientific, strategic, therapeutic, and operational management of programs to evaluate, register, and market pharmaceutical agents. Lead and direct study programs, activities, and teams for one or more projects within a therapeutic area. Mentor junior ...

  4. Maintenance Planner/Supervisor

    Our Global Manufacturing Company is looking to hire a Full TIme Planner to do the following:   This position’s primary purpose is to plan activities by the Engineering and Maintenance Department, supervise the execution of planned maintenance, and manage contracted services including guard service, housekeeping, manufacturing calibrations, HEPA filter testing, grounds keeping, pest control and others as assigned.  This position also maintains the ID badges.  three NJ facilities. One site is under a ...

  5. Information Scientist

     Hello,   My name is Amanda Tackett and I represent The Fountain Group.  We are a national staffing firm and are currently seeking a Information Scientist for a prominent client of ours.  This position is located in Princeton, NJ. Details for the positions are as follows:   Job Description:   ·         Masters degree in library and/or information science or equivalent work experience. Undergraduate degree, required. ·         Taxonomy Development Design of organization, labeling, navigation, and ...

  6. Clinical Trial Associate

    Responsibilities -Work closely with the CTM (Clinical Trial Manager) in recruiting and evaluating potential investigators for study start-up. -Participate in the planning of investigator meeting. -Responsible for sending initiation packets to sites, including follow up phone calls to sites and reporting of status at team meetings and teleconferences -Review Case Report Forms for completeness, clarity, legibility conformity to available source documentation and adherence to protocol requirements ...

  7. Clinical Research Scientist - Protocol Writing

    Summary of position: Write and/or review clinical study-related documents (e.g., clinical  protocols and summary reports, clinical study reports, investigator brochures and IB updates, informed consent form, clinical study data listing/table and regulatory agency/IRB submission documents), and managing internal review of study related documentsCollaborating with internal and external team members, investigators and KOLs Participate in safety review team meetings and summarize safety findings ...

  8. Director Biomarker Informatics - Oncology - New Brunswick, NJ

    Director Biomarker Informatics - Oncology - New Brunswick, NJ Lead a team focused on the development of personalized medicine utilizing your expertise in translational medicine, biomarker discover, companion diagnostics, and patient population identification. Develop Preclinical Strategies to optimize patient selection; *** Analyze and interpret genomic, transcriptomic, proteomic, metabolomic, and pharmacogenomic data sets derived from patient samples, databases and medical monitors *** ...

  9. Analytical  Chemist

     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 ...

  10. Machine Operators Pharmaceutical

      Our Global Manufacturing Client is looking for Machine operators for 1st and 3rd shifts. You must have the following experience: We are looking for operators with backgrounds in granulation (high shear), and blending (double cone), and the plusses would be if they had fluid bed dryers and/or processors, sifters fitzmills, V-Blenders, tablet compression machines and tablet coating machines. Please indicate what shift you are available for. Thank you!  

  11. Pharmaceutical Sales

     Description Candidate must be dedicated to addressing and solving some of the most important unmet medical needs in cardiovascular and metabolic diseases.   We work to bring innovative ideas, products, services and solutions to individuals with serious conditions, and to physicians throughout the world. We are nurturing an environment of performance excellence, built on trust, respect and accountability. Through an emphasis on strong leadership and people development, we will accelerate our sales ...

  12. Global Program Regulatory Manager-NJ

    Title: Global Program Regulatory Manager Company: Pharmaceutical Company Location: Northern NJ Status: Direct hire The GPRM works with some independence under limited supervision to provide strategic and operational regulatory direction and may support the DRA global program team (GPT) representative and/or GTAL for programs through development, registration and approval/post approval. The GPRM ensures the execution of regulatory plans in ...

  13. Global Group Head – Document Management-NJ

      The Global Group Head – Document Management is accountable for delivery of document management services globally by engaging with external partners on operations, management, performance, quality, cost and governance. In this position the incumbent will manage quality, timely and efficient processing and archiving of the paper and electronic clinical documents; Develop and maintain paper and electronic clinical document technical standards meeting internal and external requirements; ...

  14. Medical Advisor

    The Medical Advisor provides state of the art medical expertise in the therapeutic area and/or the assigned projects.  In particular, medical expertise is provided to clinical development plans, study outlines, protocols, study reports, investigator brochures, briefing packages, CTDs, draft labels and other documentation required for approval of development products. To be effective in the assigned tasks, the Medical Advisor collaborates with the other internal stake holders (Biostatistics, Clinical ...

  15. Clinical Supplies Label Operator

    Description: The Clinical Supplies Label Operator will, with limited supervision execute assembly operations for labeling clinical supplies based on issued assembly records in accordance with company SOPs and cGMPs. In order to do so, they will collaborate with Clinical Supplies Managers, the Clinical Supplies Floor Supervisor, Clinical Supplies Label Coordinator, and Inventory Technician such that they deliver quality study supplies that meet both project and regulatory requirements. Principal ...

  16. Clinical Supplies Floor Supervisor

    Description: The Clinical Supplies Floor Supervisor will, with limited supervision, plan for, schedule, and oversee assembly operations for labeling clinical supplies based on issued assembly records in accordance with company SOPs and cGMPs. In order to do so, they will collaborate with Clinical Supplies Managers, Clinical Supplies Label Coordinator, Inventory Technician, and Clinical Supplies Label Operators such that their team delivers quality study supplies that meet both project and regulatory ...

  17. Clinical Supplies Inventory Control and Distribution Technician

    Description: The Inventory Control and Distribution Technician will, with limited supervision: • Support Clinical Supplies projects in the areas of receiving, distribution, return, and destruction. • Receive product into inventory, coordinating inspection of incoming goods as appropriate. • Collaborate with Clinical Supplies Managers, the Clinical Supplies Floor Supervisor, and internal customers to achieve on-time delivery of clinical supplies that meet both project and regulatory requirements. ...

  18. Promotional Review Board Medical Editor - Contract

    Our client, a premier Pharmaceutical company, is seeking a Promotional Review Board Medical Editor for a 2 year 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, including ...

  19. PRB Proofreader - Contract

    Our client, a premier Pharmaceutical company, is seeking a PRB Proofreader for a 2 year assignment.  Pay rate is up to $32 an hour plus benefits. Proofreads PRB materials post-meeting and post-Editorial initial review. Verifies that all PRB-requested changes were implemented by agency/vendor, including but not limited to checking marketing materials for consistency. Familiar with working in an electronic format and knowledgeable about maintaining and managing this system and inherent workflow in ...

  20. Regulatory CMC Affairs Associate

    Work Description Under supervision, provide strategic and operational global CMC regulatory direction and documentation for projects/products covering development, registration and approval/post approval activities. The following activities may be performed within this capacity: Provide and/or implement global CMC regulatory strategy for development projects or marketed products Lead or contribute to global CMC submission activities (planning, authoring, reviewing, coordination, submission) for ...

  21. Manager Compensation and Rewards

    Our Global Manufacturing Client is looking for a Talented  Manager or Senior Managerfor the following: Ensure smooth and consistent implementation of Global and local reward guidelines and pay ranges in the regions directly under the positions purview. The position provides technical and consultative support to the assigned regions, countries and site on all reward, benefits and job leveling related initiatives. Rewards Related Process and Policy Review and Strategic Interventions: The focus of this ...

  22. Project Manager-Central Labs (copy 2)

    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 ...

  23. Sr. Project Manager (Central Labs) (copy 2)

    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 ...

  24. Supervisor- Central Labs (copy 4)

    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 ...

  25. QC Chemist

     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 ...

  26. Microinjectionist - Transgenic and Knockout Production - Edison, NJ

    Champion aspects of transgenic and knockout production at a major company including embryo production and recovery in transgenic and knockout mice by performing: *** Pronuclear and blastocyst injections *** Egg and blastocyst implantation into pseudo pregnant mice *** Hormone injection to induce super-ovulation *** Identify pseudo-pregnant recipients for embryo transfers *** Collect mouse eggs and blastocysts High visibility position with an international pharmaceutical company includes ...

  27. 3725106 - Expert Clinical Manager

    Responsibilities: • Candidate will contribute to the design of and oversee the implementation and conduct of phase II-IV trials and local phase IV trials in the US (Cardiovascular or Women's Health.) • Responsible for the safe conduct of clinical trials to GCP, ICH and in line with FDA regulations. • Responsible for oversight of adverse event reporting from clinical trials. • Develop publication / communication plans for local phase IV studies. • Provide Medical input to Medical/Marketing ...

  28. 3718884 - Expert Clinical Manager I

    Duties • Clinical trial management of studies within the Zometa and Established Products (EP) team under the management of the Clinical Trial Head (CTH)/Lead CTH including all study-related activities and CRO/ vendor management and oversight. • Other duties include organizing/compiling/leading the preparation of various regulatory documents including CSR appendices, Investigator Brochure updates, DSUR/PSUR/IND updates. • Writing and compiling of protocols and protocol amendments ...

  29. Nutrition & Regulatory Manager

    Contact Kristine at the phone number listed. Key responsibilities include the following: Ensure regulatory compliance of products, labels, advertising and promotions as well as adherence to policies and guidelines • Manage and develop staff and oversee contractors • Interface across the Snacks and Beverage businesses and with corporate functions to provide the nutrition/regulatory perspective and ensure projects are effectively advanced • Support implementation/tracking of corporate health & ...

  30. Medical Editor - Contract

    Our client, a premier Pharmaceutical company, is seeking a Medical Editor for approximately 2 years.  The pay rate is up to $47 an hour plus benefits. This position will be on an "as needed" basis. There is no set schedule, nor specific hours. The first two weeks of the assignment will be mandatory onsite training. Manages the delivery of a full range of editorial services, including medical editing, copy editing, proofreading, and fact verification of pharmaceutical marketing materials, internal ...

  31. Senior Director of Epidemiology 91122

    This person is to provide leadership in the area of epidemiology, with a focus on clinical drug safety, to build a high-performing team that delivers epidemiological and risk management expertise to teams that are developing new medicines or marketing innovative products to patients.   Responsibilities: As head of a newly formed epidemiology function within Clinical Safety and Pharmacovigilance , develops the vision, strategy, staffing model, and processes that will maximize the efficiency and ...

  32. Diabetes Nurse Educator

    Responsible for performing study activities regarding the management and verification of medical consistency checks (MCC) and surveillance of titration of patients within clinical trials to ensure patient safety and adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, federal regulations and SOPs. Ensures clinical investigative site staff adhere to the implementation of the treat-to-target concept to optimize glycemic control without compromising patient safety or data integrity. ...

  33. Sr. CRA - Oncology - long-term contract

    Experience: Must have Oncology monitoring experience. It is preferred to have protocol and CSR writing experience. 5+ years of pharmaceutical experience in clinical trials.  Must have an understanding of CRO/vendor management, clinical study design, CRF design, project management and familiarity with data handling. Serves as the coordinator for implementation of all clinical trial activities and management of the clinical trial in conjunction with the CRO Oversees/coordinates site visits (pre-study ...

  34. 3719813 – Outsourcing Manager

    Responsibilities: • Direct the utilization of Contract Research Organizations (CRO’s), Central Labs and Specialty Providers to assure the delivery of quality, timely and cost-effective external resources to support Development pipeline and increase shareholder value. • For assigned programs or compounds, responsible for drafting, negotiating and/or procuring and processing partially executed contracts, amendments and agreements. • Functions as the main point of contact, tracks the process and ...

  35. Scientist-Nutrition Business Devolopment

     M.S./ PhD in Nutrition, Registered Dietitian, Preferrably experience from a major food manufacturer. Knowledge of food labeling regulations, Working with new product lines, enhancing current products,  cost savings to making lines more profitable, Provide technical nutrition leadership for claims and development, emerging science opportunities, and build strategies for health and wellness brands Base, Bonus, full benefits package

  36. Electronic Submission Specialist 3 month contract 91151

    Skills/Knowledge Required: o BA/BS Degree, 2 yrs. pharmaceutical industry experience, prior Regulatory Operations experience required o Knowledge of IND, NDA, MAA, CTD requirements and guidelines, both paper and electronic o Knowledge of industry trends regarding electronic submissions o Technical knowledge of electronic publishing systems and software o Proficiency with MS-Office Suite and Adobe Acrobat applications o Knowledge of health authority procedures/guidance’s regarding electronic ...

  37. Maintenance Supervisor Pharmaceutical

      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 ...

  38. Director of Quality QA/QC

     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 ...

  39. Engineer III / Electrical Engineer

     Proficiency with schematic capture and pcb layout CAD tools • Proficiency in using oscilloscopes, voltmeters, and other electronic tools • Intermediate level skills in analog and digital circuit analysis • Experience with debugging imbedded systems and analog circuits • Good verbal and written communication skills.  • Candidates best suited for this position will typically have obtained a Bachelor's degree and 5+ years of experience in a related field or a suitable combination of experience and ...

  40. Chief Scientific Officer - Drug Development Strategies - Hopewell, NJ

    Seeking 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. Shall work closely with heads of multiple therapeutic areas and drug discovery units to drive clinical-to-preclinical backward collaboration in an effort to more effectively select targets and entities at the basic science, pre-clinical, and non-clinical stages. ...

  41. Research Associate - Microinjection & Blastocyst Implantation

    Assist with aspects of genetically modified mouse creation including embryo collection, DNA cell microinjection, embryo transfer, animal care, and detailed record keeping. Must possess at least 3 years experience performing DNA or ES cell microinjection experiments on a daily basis for the routine, predictable, and reproducible production of genetically modified mice. Work along side our industry recognized, Ivy League personnel in this high growth position. Top base salary to $70,000 and added ...

  42. AVP Clinical Pharmacology - New Brunswick, NJ

    Seeking PhD, PharmD or MD with 5+ years of executive level strategic leadership experience and track record in pharmacology operations for drug development in clinical stages utilizing strategic partners, licensed technologies, and contract research organizations. Must have solid track record in CLINICAL pharmacology, pharmacokinetics, ADME & DMPK research support. High visibility executive position with Global Big Pharma company includes extensive perquisites, company equity, significant bonus ...

  43. Senior Clinical Trial Manager

    Responsibilities: • Participate in all aspects of clinical development and study management, which includes providing logistic and scientific support to planned and ongoing trials. • Manage the successful planning and execution of clinical trials. • Oversee tracking of clinical trial progress through regular documented contact with sites, Regional Site Managers and vendors. • Accountable for timely results of team by providing follow up on goals and objectives and addressing performance issues, as ...

  44. Clinical Trial Manager (copy 2)

    Clinical Scientist I/II and Sr. Clinical Scientist: CNS Summary Participate in all aspects of clinical development and study management under the direction of the Director, or designee, which includes providing scientific, and/or logistical support to planned and ongoing international trials Duties and Responsibilities * Author drafts of study synopses, protocols, protocol amendments, Monitoring Plan and informed consents for Phase II-IV studies. * Contribute to the preparation of ...

  45. Regional Clinical Research Associate

    This is a permanent position. Must have strong experience in Solid Tumor and/or Oncology. Canidates to be located in: NJ, NY, or CT Region to cover: NJ, NY, CT, and PA 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 ...

  46. Junior Chemist

    Successful candidate will be responsible for conducting analytical tests of pharmaceutical raw materials and finished products, with focus on oral solid dosages (capsule, tablet, softgel etc.)   Major Duties/ Responsibilities:   Perform analytical testing for pharmaceutical raw materials. Perform wet chemistry and chromatographic testing for products under development phase, with most emphasis on HPLC and dissolution testing. Conduct wet chemistry and chromatographic analytical method comparisons, ...

  47. Associate Principal Scientist - Food Product Development

    Contact Kristine at 815-756-1221 Qualifications: - BS/MS Food Science - 6+ years of successful product & process development experience in snack foods - Strong technical foundation with ingredient functionality from cereal, grains, cakes, etc. - Experience leading programs through the development cycle - Project management skills - Ability to interface with marketing, operations, procurement and regulatory - Excellent communication skills Duties: - Develop new products and processes from bench top ...

  48. Sr. Scientist Food Products

    Contact Sonja at 815-756-1221 for more details The Sr. Scientist will be responsible for the commercialization of new products and providing technical leadership and project management to deliver business objectives. Qualifications: - BS/MS Food Science - 8-10 years of food product development in a large CPG company - Experience developing pet food products a plus but not required - Excellent communication and leadership skills - Technical troubleshooting skills - Able to deliver project objectives ...

  49. Associate Director/Director, Post-Marketing Regulatory Affairs

    Associate Director/Director, Post-Marketing Regulatory Affairs Location: Basking Ridge, NJ (Local Preferred) This is a permanent position reporting directly to the CMO of this small pharmaceutical organization.  Exciting opportunity for a post-marketing and compliance pro! The Associate Director / Director, Post-Marketing Regulatory Affairs ensures OPDP compliance for all approved therapeutics and prepares and manages corresponding reports. Leads the post-marketing regulatory group for excellence; ...

  50. Clinical Database Programmer

    The Clinical Database Programmer will lead the development and maintenance of database builds in support of clinical studies.  He / she will build study databases including development of database specifications/definitions, programming of CRF layouts, programming of validation and derivation procedures, and programming of various reports to support the data review process.  The Clinical Database Programmer will troubleshoot technical issues as required for staff regarding specific database issues.  ...