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careers@globalpharmatek.com

We aspire to be the Clinical Research Organizations that is a solid contributor in driving more customer projects in the market or is an important decision-maker in the whole industry. In brief, we want to be the partner of choice in the process of drug development. That is our core vision, which drives all our efforts and for that, we never cut down the need to hire more talented people and achieve that goal.

If you share our aspirations then join us today. By being a part of us, you will be able to bag the chance to work in a spectacular environment with the most intelligent and innovative team, moreover, you will be making a contribution that will help shape a better industry!

Current Openings

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Global PharmaTek, LLC has job openings for Sr. Validation Engineer Jobs located in Edison, NJ and various unanticipated locations throughout the U.S.

Job Duties:

  •   Writing of Validation documents per Food and Drug Administration (FDA)/Company Guidelines.Utilizing the information from User Manuals, Equipment Operation/Use/Maintenance etc information and drafting of specification documents and validation protocols for GMP Liquid Dose Manufacturing (LDM) clinical Drug Product (DP) that impact manufacturing facility (processes, equipment (like autoclave, lyophilizers, depyrogenation tunnels etc
  • Creation/modification of change control requests, project validation plans and maintaining project within timelines. If any changes were deemed necessary in the equipment (Changes may be like changes in parts or operation of the equipment or changes in procedure or changes in Training of personnel or On-boarding/retiring equipment etc.) I will create a change request in global Quality Tracking System (gQTS), a Trackwise application and thereby monitoring these changes by performing required assignments throughout the project to completion (closing change request) for the current filling and sterilization equipment and install/qualify the new equipment.
  • Involve in qualification and re-qualification/re-validation of pharmaceutical equipment used in preparation of clinical/pharmaceutical drug product.
  • Generate all necessary electronic summary reports required for the efforts above. These Summary reports will be submitted during FDA or other regulatory agencies during site inspections or audits as a proof that the system/equipment is compliant with current good manufacturing standards. This includes drafting, reviewing, receipt and addressing of comments and securing approvals

Requirement:  Bachelors in Biochemistry, Chemistry, Pharmaceutical Sciences, or a related field and relevant 1-2 years of experience.Ref No: 18GPH06

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Global PharmaTek, LLC has job openings for Submission Specialist – Regulatory Affairs Jobs located in Edison, NJ and various unanticipated locations throughout the U.S.

Job Duties:

  • Providing direct support to submission project teams, internal RA stakeholders and all functional disciplines responsible for developing and delivering components for submissions.
  • Performing hands-on daily submission compilation and publishing activities associated with preparation of various dossier types and safety reports, for both new product marketing applications and/or marketed product maintenance packages.
  • Performing overall quality of the assigned documents and dossiers which must comply with all internal Bayer best practices, meet global regulatory requirements, and facilitate the review and timely approval by appropriate regulatory authorities.
  • Reviewing the eCTD compliance of dossier-relevant R&D documents/reports from technical perspective.
  • Supporting the compilation of global dossiers and to deliver technically compliant submission documents/reports, which contribute to the development of submissions that meet the technical requirements and standards set by relevant health authorities.
  • Performing the technical review of components for eCTD submissions ensuring the  components/documents/reports are technically compliant (including the technical improvement of legacy documents/reports not meeting requirements), assigning submissions components to the appropriate submission location, applying an appropriate level of necessary navigational aids (e.g. inter-hyperlinks, bookmarks), and validating the output with appropriate tools.
  • Working closely with Regulatory Affairs Managers/Liaisons, under the direct supervision of a Regulatory Submissions Leader (RSL) and/or RSMP Management to ensure: overall technical content of the submission and the quality of the dossier meets the (navigational) requirements of the reviewing health authority and is in alignment with established global business objectives, format meets all internal requirements.
  • Executing all operational activities associated with compilation, publishing and distribution of submission components under the direct supervision of a Regulatory Submissions Leader and/or RSMP management.
  • Working on diverse submission types and complexity include all potential dossier types worldwide.
  • Responsible for applying all global regulatory guidance and regulations associated with the technical assembly and publication of submissions (paper, electronic and/or non ICH formats) with oversight from a RSL and/or RSMP management.
  • Ensures achievement of submission milestone dates for assigned publishing support activities.
  • Identifies and documents issues that risk the submission timelines and escalates the issues to the RSL and/or RSMP management to recommend appropriate resolution.

Requirement: Bachelors in Regulatory Affairs ,Healthcare Administration, or a closely related field and relevant 1-2 years of experience.Ref No: 18GPH01

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Global PharmaTek, LLC has job openings for Specialist Study Management Jobs located in Edison, NJ and various unanticipated locations throughout the U.S.

Job Duties:

  • Review and process start up documents, including Sub Investigator’s documents in compliance with ICH-GCP, and client’s Procedural Documents;
  • Assist SATS with obtaining and maintaining essential documents in compliance with ICH-GCP, and client’s Procedural Documents;
    Drive delivery of regulatory documents at the sites.
  • Proactively identify delays in start-up activities and the risks to the activation plan;
  • Attend weekly study team meetings and be prepared to provide a report on vendor spreadsheet status and sub I document status;
  • Update IMPACT and other systems with data from centers as required per SAT process;
  • Ensure regulatory binders and study supplies are provided for study site start up and/or delivered as per SAT process and agreement with Local Study Delivery Team;
  • Create and/or import clinical-regulatory documents into the A New Global Electronic Library (ANGEL) according to the Global Document List (GDL) ensuring compliance with the client’s Authoring Guide for Regulatory Documents to support publishing in ANGEL;
  • Set-up, populate and accurately maintain information in client’s tracking and communication tools (e.g. IMPACT, Box, etc.) and support others in the usage of these systems; and Prepare regulatory binders and study supplies for distribution to the sites per) ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents to support publishing in ANGEL.

Requirement: Bachelors in Healthcare Administration or a closely related field and relevant 1-2 years of experience.Ref No: 18GPH08

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Global PharmaTek, LLC has job openings for Regulatory Affairs Compliance Specialist. Jobs located in Edison, NJ and various unanticipated locations throughout the U.S.

Job Duties:

· The Regulatory Affairs (RA) Compliance Specialist will be responsible for RA Labeling compliance associated with labeling artwork development and revisions for products which may include Rx, OTC/Nutritionals, Cosmetics, and Devices. Specialist will verify the changes in accordance to regulatory requirements to identify impact to product labels. As a key team member, contributes to the labeling processes and procedures to enhance existing practices

· Provide Regulatory compliance support in the development, revision, review, and approval of labeling content for regulatory submission, as well as any post marketing labeling changes.

· Review new and revised labeling for accuracy and for appropriate regulatory requirements

· Provide RA Compliance support for the CAPA actions and verifications

· Liaise with Regulatory Affairs members and other cross-functional teams (e.g., supply chain, legal, medical, pharmacovigilance) to ensure the accuracy of all information included on the label or in the labeling.

· Provide the RA compliance approval on labeling review process steps and coordinate with other Regulatory functions during the submission, approval, and notification of new/revised labeling content.

· Review all labeling materials in accordance with company policies, procedures, and technologies

· Support in revision of Labeling SOPs and reference documents and make sure it is aligning with current regulations and company policies.

· Participate and provide RA compliance support during Internal/external audits

· Support additional RA Compliance activities as required.

· Other job responsibilities as needed

Requirement: Bachelor’s Degree in Pharmaceutical Science, Regulatory Affairs or a closely related field and relevant 1-2 years of experience.Ref No: 17GPH05

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Global PharmaTek, LLC has job openings for Equipment Validation Engineer Jobs located in Edison, NJ and various unanticipated locations throughout the U.S.

Job Duties:

· Provide technical support in developing, authoring, and executing the Commissioning, Installation and Qualification protocols for the chromatography skids and other supporting equipment that are used in the production of drug

· Develop, Implement and Install filter integrity testing methods to available automated Filter Integrity Testers (FITs) available on site to verify the integral of the vent filters that will used in the process for WFI Tanks, Autoclaves, supply clean compressed air and as required

· Prepare protocols and reports for Validation Project Plan, Validation Master Plan, IQ, OQ, OQ, Traceability Matrix, Engineering test Plans, and Commissioning test strategies following the site Good Data and Documentation Practices (GDP) during protocol execution for qualifying the system or facility

· Develop and execute test strategy for the qualification of automated cleaning methods, Clean Out of Place (COP), Steam in Place (SIP), and Clean in Place cleaning process for manufacturing equipment and facilities that are used in cGxP regulated environment

· Work independently in executing the validation activities in qualifying the Temperature Controlled Units (TCUs) such as Incubators, Autoclave, Cold Rooms, Freezers, Refrigerators and other manufacturing equipment

· Perform risk assessment on the manufacturing equipment, facilities, and utilities to define the risk level and recommend the frequency of validation maintenance with its impact on the product/process in case of failure

· Perform Commissioning and Qualification of HVAC, WFI storage tanks, and building management systems

Requirement: Bachelor’s Degree in Mechanical Engineering, Industrial Engineering or a closely related field and relevant 1-2 years of experience.Ref No: 19GPH07

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Global PharmaTek, LLC has job openings for Regulatory Affairs II. Jobs located in Edison, NJ and various unanticipated locations throughout the U.S.

Job Duties:

  • Managing and delivering regulatory submissions to global health authorities required to support the maintenance, development and registration of products and performing the following required activities depending on the particular project and assigned submission(s);
  • Establishing Dossier Plans for the assigned Global submission types as needed to support the lifecycle of one or more products in generating dossier plans that will reflect inputs from functional area representatives and key stakeholders;
  • Meeting regularly with submission stakeholders and cross-functional representatives to identify and resolve issues and to assess quality and delivery of Dossier Plans, quality of deliverables and timelines against established KPIs;
  • Ensuring relevant submission process(es) are applied to all assigned submissions, including coordinating the electronic component and dossier level publishing and production of regulatory submissions that conform to regional and country specific regulatory requirements as appropriate.
  • Ensuring dispatch/distribution in compliance with due dates to Health Authorities and/or Local Operating Companies, as applicable, tracking submission events/activities in appropriate systems/tools.
  • Support development of departmental work practices, process enhancements, and associated training materials.
  • Develop/maintain associated process tools and relevant training documentation.
  • Support compliance needs as appropriate.
  • Apply appropriate regulatory submission standards, requirements, processes and policies to comply with applicable health agency requirements.
  • Maintain open, timely and effective communications with all publishing contributors and responsible RA professional, to ensure timely delivery of dossier components and/or complete dossier for submission.
  • Participate on special projects and process improvement initiatives, as needed.

Requirement:  Bachelor’s Degree in Pharmaceutical Science or a closely related fieldand relevant 1-2 years of experience.Ref No: 19GPH08

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Global PharmaTek, LLC has job openings for Intake DSA. Jobs located in Edison, NJ and various unanticipated locations throughout the U.S.

Job Duties:

Receiving clinical study SAE reports, reviewing for medical/regulatory content, and assuring accuracy per protocol requirements while obtaining follow-up as needed; Ensuring that all SAE’s are complete prior to database closure Process; Receiving, processing, and distributing spontaneous adverse event reports for marketed products, both serious and non-serious, as per the company’s SOP’s; Also processes Clinical trial, post-marketing surveillance and literature adverse event reports. And write clinically valid narratives. Assessing events causal relationship to the drug and labelling. Coding of adverse events, medical history, lab data, and indication using MedDRA and concomitant and treatment medications using WHODD. Identify potential 7-Day and 15-Day Alerts and Report endpoints to FDA or other regulatory authorities and ethics committees within specified timelines. Supports the management of case processing deadlines for aggregate safety reporting. Assisting with preparing and/or reviewing safety summaries for Investigator Brochures and annual reports, safety submissions for marketed products, and other safety reports as needed or requested. Performing data migration between safety databases by harmonizing safety data management with pharmacovigilance business processes. Distributing clinical study SAE reports as per the company SOPs;Performing reconciliation with licensing partners and CROs to ensure compliance and accurate receipt of all adverse event information. Ensuring all cases are complete and all outstanding queries are resolved and closed after reconciliation. Accept E2B cases received through the ORACLE ARGUS Electronic Submissions Module (ESM), generating line listings and summary tabulations.Assisting with providing safety support and training for clinical, monitoring, and clinical site personnel as needed; and Ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).Collaborate with Global Quality and Compliance team by reviewing weekly listings of late submissions for accuracy and identification of Root Cause Analysis (RCA) and assignment of CAPA (Corrective and Preventative Action) to responsible parties.Review of vendor case deactivation requests to ensure AE data is has been completed correctly, case merges are complete and correct and that the request is valid. Push valid requests for business approval or reject and communicate issues/request corrections from vendor.Determine necessary follow-up for missing, information/source documentation for each case using medical, product and regulatory knowledge. Maintain current knowledge of all applicable FDA/EU/ICH/NDA guidelines and regulations relating to safety and Pharmacovigilance reporting.Participating in other relevant safety projects as assigned.

Requirement: Bachelor’s Degree in Pharmaceutical Sciences or a related field and relevant 1-2 years of experience.Ref No: 19GPH06

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Global PharmaTek, LLC has job openings for Quality Engineer. Jobs located in  Edison, NJ, and various unanticipated locations throughout the U.S.

Job Description:

• Supporting Manufacturing through implementation of new product introduction activities
• Support manufacturing changes
• Managing CAPA projects using Problem Solving Tools while keeping to predefined deadlines
• Maintaining Risk Management Documents for Released Product (includes Risk Managements Plans/Reports, Risk Analysis Documents, Risk Management Files, dFMEA and pFMEA)
• Assist with Process and Test Method Validation efforts
• Support nonconformance dispositions and manufacturing line
• Performs other related duties as assigned

Bachelor’s Degree in Engineering or Scientific Discipline +2 years of experience as a manufacturing engineer, quality engineer or other engineering position in medical device or regulated industry

  • Position will require supporting 2nd shift manufacturing lines and/or weekends.
  • Previous experience in a quality engineering position strongly preferred.

Physical Job Requirements:
• The physical demands described within the Responsibilities section of this job description are
representative of those that must be met by an employee to successfully perform the
essential functions of this job. Reasonable accommodations may be made to enable
individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to be
independently mobile.
• The employee is required to interact with a computer, and communicate with peers and co-workers.
• Extended periods of time doing computer-based work.
• Able to work in cleanroom/controlled environment areas
• Ability to work nights and weekends as needed

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Global PharmaTek, LLC has job openings for Quality Engineer. Jobs located in Irvine, CA, and various unanticipated locations throughout the U.S.

Job duties:

The Mechanical Engineer, Research & Development will support the Critical Care Mechanical team working on new product designs, technology development and sustaining of core product lines with an emphasis on hands on new product development.

Key Responsibilities:

  • Support the development of critical care devices or subsystems thereof from concept to commercial launch
  • Apply engineering principles to the design of electro mechanical medical devices, effectively use tests and simulations to expedite development in a fast paced environment
  • Design, prototype and test components of medical devices, develop new test methods to evaluate devices
  • Work with internal and external resources to contribute to the design and development, testing and release of electromechanical components used in medical device systems
  • Solve technical issues working as a contributing member of a diverse engineering team
  • Integrate development of medical technology by assuring the design of technology interfaces and system elements works together as a whole
  • Write design verification and validation protocols and reports in accordance with quality procedures assuming full ownership as the Study Director
  • Provide solutions to the technical aspects of product design and development as well as the translation of marketing requirements into product specifications
  • Work with R&D technical teams (Mechanical, Electrical, Systems, Software) and internal partners in the Marketing, Regulatory, Quality, Clinical, Manufacturing and other departments to deliver project objectives.

Education and Experience:

  • · Bachelor’s Degree in Mechanical Engineering with 0-2 years experience (Master’s or PhD degree lessens the experience required for the position)
  • · Must have good 3D CAD skills in SolidWorks.
  • · Working knowledge of basic statistics and six-sigma principles
  • · Requires strong technical aptitude, leadership, communication, writing and coordination skills
  • · Requires a high-energy individual who has excellent teamwork, partnering, and negotiation skills
  • · Must be a highly motivated self-starter who is able to achieve results with minimal direction
  • · Must be proactive and creative in achieving goals
  • · Must have strong conflict resolution skills:

Additional Skills

  • Previous mechanical design experience with disposable devices, capital equipment, and/or sensors (pressure, flow, optical).
  • · Proficiency in mechanical design, tolerance stack-up analysis, design for Manufacturability (DFM), and specification development
  • · Experience in design verification & validation within an FDA regulated industry
  • · Experience with design control procedures
  • · Experience with Solidworks, LabView, MatLab, and quantitative analysis of data
  • · Knowledge of relevant manufacturing processes like injection molding, extrusion etc.
  • · Comfortable in a dynamic working environment with multiple priorities

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Global PharmaTek, LLC has job openings for Regulatory Affairs Project Manager. Jobs located in Edison, NJ and various unanticipated locations throughout the U.S.

Job duties:

Providing technical writing, review, editing, and formatting of drafts and related materials for Chemistry, Manufacturing, and Controls (CMC) sections of regulatory applications; Compiling, archiving and preparing CMC submission packages using document management systems like Documentum, Global SharePoint, and local shared drives and performing agency submission activities; Performing and documenting activities for submissions to regulatory agencies, registering facilities, and preparing and filing the documents electronically in Common Technical Document (CTD) format; Maintaining a schedule of filings required and recommended by the Food and Drug Administration (FDA), and monitoring timelines and status for filings complete routine filings in a timely manner; Preparing special reports and regulatory projects, including supporting documentation; Assisting in the development and continuous improvement of business processes, tools, systems, metrics, and analytics under the supervision of the Head of Regulatory Affairs;Continuously analyzing the current process and take the process initiative steps, take necessary actions by communicating with cross-functional teams, and obtain the operational excellence for the Regulatory Affairs team by enhancing the work efficiency of the tools and systems used to perform the RA activities. Performing analytical evaluations, determining the future outcomes, and preparing the teams for the Information Technologies changes;Utilizing and maintaining Regulatory Information Management system (Extedo), Electronic Document Management System (Documentum), TrackWise, Electronic Common Technical Document (ECTD) submission tools, SharePoint, Replicon, SAP, Adobe Acrobat to support compliant operational execution of activities related to dossier preparation and submissions, as needed;Preparing analysis reports for the submissions and additional supporting documentation when required, like training material, SOP’s, and department best practices documents as needed; Reviewing and approving internal change documents such as investigation reports, deviation reports, and SOPs. Evaluating changes for potential regulatory impact and provides guidance to clients for appropriate regulatory agency notifications;By using TrackWise system, managing change controls, deviations, corrective, and preventive actions (CAPA’s). By performing, the pre-assessment step of the proposed change/deviation and assessing the regulatory impact of proposed change/deviation and make a recommendation. Monitoring and communicating submission status to affected stakeholders and finalization of all regulatory actions to prepare for change/deviation closure. Providing recommendations for corrective and preventive actions; Interacting with clients and potential clients to develop regulatory strategies, proposals, and assist in writing regulatory submissions. Providing benefit/risk analysis for suggested strategies;Managing client regulatory submissions from initial client contact through drug product approval and post-approval commitments;Interacting with internal departments to improve facility processes and systems and provide the regulatory impact of proposed improvements. Evaluates process and system improvements for potential regulatory impact;Interacting with domestic and foreign regulatory agencies and clients in relation to facility improvements and client submissions;Ensuring that all CMC documentation, which directly or indirectly supports the preparation of regulatory submissions, are prepared to meet requirements;Organizing and coordinating information and requirements; planning, arranging, and meeting schedules; monitoring results;Evaluating regulatory requirements related to the updating and instituting of quality policies in the monitoring of the environment, air, surfaces, water, and gowning to meet current industry standards;Preparing monthly Key Performance Indicator (KPIs), reports, including budget reporting;Monitoring and maintaining policies compliant with FDA regulations and guidance; Performing other duties as assigned;Interacting with Lonza Houston customers and FDA regulatory support to expand the CGT business;Coordinating the various projects in the local regulatory team; scientists; technicians and consultants;Exploring and evaluating business opportunities; and Conducting regulatory evaluations of new projects.

Requirement: Bachelor’s Degree in Information Systems or a related field and relevant 1-2 years of experience.Ref No: 18GPH07

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Global PharmaTek, LLC has job openings for Laboratory Equipment/Instrument Qualification Engineer. Jobs located in Edison, NJ and various unanticipated locations throughout the U.S.

Job duties:

  • Execute Validation and Qualification protocols which include installing, operating and maintaining of GMP Lab Equipment and Instruments (HPLC, UV-Vis Spectrometers, FTIR, GC, pH meters, Conductivity meters, Analyzers etc.) and manufacturing equipment like sterilizers and autoclaves to confirm if the instrument is compatible and compliant with Manufacturing, analysis, Company and FDA regulations
  • Author, review and approve validation and qualification documents for Lab Equipment/Instruments and manufacturing equipment in compliance with Pharma and FDA guidelines through Document Management system tool;
  • Perform validation and qualification documents include User requirement specifications, functional requirement specifications, Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Validation summary reports, Change Control etc. for various lab instruments utilized by Quality control and Quality assurance teams;
  • Perform Sample data analysis through chromatograms, chemical composition, retention times, wavelength absorbance and calculations for data generated from lab instruments;
  • Generate, review and revise site governing Standard Operating Procedures for Laboratory and Pharmaceutical equipment’s per analytical chemistry and equipment scope in manufacturing;
  • Work on SOPs such as Laboratory and manufacturing equipment qualification, data integrity controls, User and system administration, User manuals and Equipment (Usage, Calibration, maintenance);
  • Draft SOPs in Documentum tool. Revising the SOPs in Documentum for any modifications done to the lab equipment or procedures;
  • Execute Qualification protocols and analysis of data generated from instruments such as HPLC, Spectrometers etc. for continuous improvement of quality systems;
  • Compose and write descriptive reports that include chromatograms, spectra, sample/ analyte concentrations, Chemical calculations, Sample retention times etc. and using appropriate techniques to implement programmatic activities (example: MS Excel) for analyzing the data;
  • Investigate for any errors, defects, non-conformances or incorrect results observed during validation/ qualification activities and resolving them through deviation or discrepancy reports, corrective and preventive actions, change control by utilizing Trackwise Tool;
  • Perform GAP analysis based on severity, occurrence, detection levels of an error, discrepancy or deviation, and perform Risk assessment to check its impact on product manufactured and patient health, thus implementing necessary Corrective and Preventive actions (CAPA) to minimize the risk;
  • Perform 21 CFR part 11, GxP and data integrity assessments for computerized and standalone lab instruments to follow FDA and other regulatory guidelines including the job duties that follow;
  • Verify electronic signatures (unique user login IDs, passwords, access levels, permissions, roles and responsibilities), electronic records (reports generated by computerized equipment, archives permissions, data backup) and Audit Trails capability Information about GMP data: creation, tracking, modification and deletion) of the instrument;
  • Perform calibration and maintenance activities of HPLC, GC, FTIR, UV spectrometer, osmometers, blood and metabolite analyzers, balances and pH meters;
  • Support internal audits and chart reviews to assist with monitoring and tracking of GMP data quality for compliance with FDA and other regulatory standards.

Requirement: Bachelor’s Degree in Pharmacy,Chemistry or related fields and relevant 1-2 years of experience.Ref No: 18GPH06

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Global PharmaTek, LLC has job openings for Associate Operations Specialist. Jobs located in Edison, NJ and various unanticipated locations throughout the U.S.

Job duties:

  • Review, assess and process Lifecycle Safety data and information, across all service lines received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members.
  • Receive, triage, review and process data from various sources on time, within budget and meet quality standards.
  • Perform data entry for tracking and safety database, coding relevant medical terminology, writing, descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines.
  • Pre-process material for endpoint committee or core laboratory adjudication.
  • Preparation of material for submission of primary review.
  • Assess Lifecycle Safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, and investigators, oversight groups per legislation, within timelines and in a format compatible to requirement.
  • Liaise with local Quintiles offices to facilitate expedited reporting.
  • Receive and document incoming telephone calls, faxes or emails from investigative sites or other sources reporting Lifecycle Safety data.
  • Process Lifecycle Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
  • Assist operations team with tasks, provide for back-up to the operations team, assist in generation of status reports, providing project metrics, drafting project instructions/guidelines and assist in implementation of new processes.
  • Contribute under guidance of senior staff to individual deliverables in the field of Safety Publishing,Risk Management, Safety Surveillance and Medical Information, or other service lines as appropriate.
  • Liaise with different functional team members, e.g. project management, clinical, data management; health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues.
  • Attend project team meetings and provide feedback to operations manager on any
  • Challenges/issues or successes.
  • May liaise with client in relation to details on day to day process of cases.
  • Perform operational and collaborative LSM task as directed by Lifecycle Safety Infrastructure.
  • Ensure compliance to Quintiles high quality standards and work with LSM constructively in a matrix framework to achieve project and customer deliverables.
  • Executes administrative operational tasks as required e.g. committee and laboratory management.
  • Collaborate with SO and LSM to help achieve operational departmental goals i.e. understands metrics appropriate to quality document management and assist in the achievement of productivity utilization and realization metrics.
  • Read and acknowledge all necessary Quintiles standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring your individual training plan and training transcript are reconcilable.
  • Perform other duties as assigned.

Requirement: Bachelor’s Degree in Pharmacy, Pharmacology or related fields and relevant 1-2 years of experience.

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Global PharmaTek, LLC has job openings for DSUR Coordinator. Jobs located in Edison, NJ and various unanticipated locations throughout the U.S.

Job duties:

  • Work closely with regulatory submission managers to lead the production of high quality submission assemblies utilizing submission-ready documents that adhere to internal and regulatory authority electronic submission guidelines.
  • Ensure regulatory submission documents assemblies meet the level of technical integrity required for client and regulatory authority validation tools .
  • Assume the lead for training/mentoring internal and external regulatory publishing staff
  • Assist regulatory submission project teams with the identification of submission ready content requirements and applicable timeline milestones for execution of right-first-time submission assemblies
  • Identify, assess and actively resolve or escalate where necessary any risks or issues that could impact the successful completion of regulatory submissions
  • Assist with departmental metrics by tracking status of projects, day-to-day production activities, and publishing anomalies
  • Execute and adhere to Regulatory Operations work practices and guidelines, as well as author new processes as required.
  • Manage the daily tasks associated with publishing, assigning publishing tasks, resolving document issues, and daily communication with stakeholders
  • Assume the lead role in the development of publishing processes and documentation, including user acceptance testing for new and updated publishing tools. Delegation of these project activities to publishers within the department as needed .
  • Assume the role of subject matter expert for specific functions or processes, interacting and mentoring both within the department and with external.
  • Evaluate activities and business processes, identify areas in need of improvement and take the lead in investigating potential solutions or new ways of working.

Requirement: Bachelor’s Degree in Pharmacy, Regulatory Affairs or closely related fields and relevant 1-2 years of experience.

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Location: Hyderabad, India

Job Description:

We are hiring for BDM/BDE position for our recruitment in India.
Candidates with 3-5 years of experience in recruitment industry, with previous relevant experience.

investigation.

Roles & Responsibilities: 
  • Client acquisition for permanent staffing / Contract Positions
  • Client Management ( From requirements to proper payments)
  • Responsible in making the revenue generation acquiring new business.
  • Proper coordination with the recruitment teams and relationship managers to generate quality results.
  • Build and maintain rapport with the New & Existing clients.
  • Accountable for all client proposals, contracts, and any further documentation.
  • Bring new business to the organization,
  • Responsible for the entire recruitment process clients.

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Location: NC
Duration: 12+ Months
Experience: 6+ years
Qualification: Bachelors

Job Description:

  • Looking for people that are experienced performing investigations which require different skills from those reviewing, evaluating and approving.
  • They also need to be willing to do the leg work required to gather the data, evaluate, interview, analyze to come to conclusions and then write the investigation.
  • They must also be proficient in the use of Track wise which is the software used to document the investigation.

Responsibilities:

  • Conduct and oversee investigations for terminally sterilized products
  • Investigation areas of focus: Engineering, Chemistry and Microbiology laboratories, equipment and calibration, procedural gaps, validation failures, method transfer, out of specification Phase I (lab) and Phase II (manufacturing). Aseptic technique exp.
  • CA/PA (Corrective and Preventative Actions) – improvement to laboratory systems for instrument calibration/qualification, implementation of controls to prevent microbiological contamination of product, procedural simplification
  • Mentor investigators and QA team members for technical writing, investigation techniques, identification of realistic CA/PA’s, and scope of product impact
  • Track Wise
  • Document preparation
  • Audit preparation support Metric reporting
  • Mentoring of analysts for investigations

Apply Job Description:

Clinical Business Process Analyst provides support to Clinical R&D relating to Company’s Clinical Trial systems like Interactive Response Technologies (IRT) or electronic Clinical Outcomes Assessment (eCOA) systems.

  • The candidate will be working with internal team and vendors to create specifications, user acceptance testing (UAT) scripts, manage execution of UAT, support vendor oversight, manage system related documentation.
  • The individual must have working knowledge of GCP requirements for system development and management.
  • The individual must have at list 3 years of experience building IRT and\or eCOA system in a clinical study set up.
  • The person must have good communication skills.

Mail resume with cover letter to Global Pharma Tek, LLC, 2025 Lincoln Highway, Suite 225, Edison, NJ 08817; Job 16GPH19; EOE

Apply Job Description:

We are seeking a temporary Quality Systems Specialist to join our Quality Systems group to perform a variety of activities to ensure the safety, quality, and efficacy of our product. The Quality System Specialist will be responsible for general support and maintenance of the Quality System within the requirements of FDA Quality System Regulation (QSR).
The primary duties for this individual will be to review and approve laboratory investigations, deviations and CAPA and support the Change Control program. Additional functions include writing and revising standard operating procedures, training, and tracking and trending data. Duties for this position support Manufacturing, Quality Control, Quality Assurance, product release, and training.

Mail resume with cover letter to Global Pharma Tek, LLC, 2025 Lincoln Highway, Suite 225, Edison, NJ 08817; Job 16GPH19; EOE

Responsibilities include but are not limited to:

  • Monitor, review and approve laboratory investigations, deviations and CAPA (including CAPA effectiveness checks) in the Quality Management System.
  • Track and trend Quality System Data.
  • Perform Root Cause Analysis.
  • Review of change controls for content and completeness.
  • Generate and update standard operating procedures to define and improve quality system functions.
  • Participate in the implementation and monitoring of the QMS training program.
  • Interface with other departments regarding documentation requirements and complex investigations.
  • Prepares information related to the state of the QMS to be used in routine monthly reporting and Quality Council meetings.
  • Proactively, based on data analysis, recommends to management areas of improvement within the various operations.
  • Participate in continuous improvement projects as required.

Minimum Requirements:
• Bachelor’s Degree in a relevant life science field such as Biology, Microbiology, Chemistry, Biochemistry, etc. with at least 8 years of working experience in Quality Assurance, Quality Control or Manufacturing.

Apply Location: PA
Duration: 6 Months
Job Description:

  • Very strong CPA to fill an Accounting Manager position that will oversee a portion of the general accounting function along with multiple staff members.
  • Strong background and understanding of GAAP accounting and reporting
  • Experience in service-oriented or shared services finance organization is a plus
  • General accrual accounting, along with balance sheet experience are a plus
  • Manage the month-end close and ensure accurate and timely reporting of the Financial Statements to Group level
  • Ensure GAAP and SOX compliance in financial statements while obtaining maximum efficiency and effectiveness in our processes.
  • Review journal entries and supporting documentation for accuracy
  • Review account reconciliations and supporting documentation for accuracy
  • Other Ad hoc projects Essential
  • Financial BS and P&L analytics experience
  • Strong knowledge of MS Excel Preferred
  • CPA Preferred
  • Recent SAP experience is a plus
  • Pharmaceutical experience is a plus Skills/Behaviors
  • Good Organizational skills
  • Able to work with and communicate with various stakeholders that are not part of Finance
  • Ability to work in a fast paced environment

Apply Job Description: Global PharmaTek, LLC has job openings for Pharmacovigilance Scientist. Jobs located in Edison, NJ. Review non-serious and serious AEs and aggregate AE listings. Prepare signaling meeting presentations in collaboration with the team, including a review of events of interest, initial trending of AEs, set thresholds for escalation, and preparation of meeting minutes. Monitor the safety profile of assigned compounds to identify any safety signals and support execution of plans for signal evaluation. Requires Bachelor’s degree or foreign equivalent in Computer Science, Engineering (any), Public Health, Biotechnology, Life Sciences, or related. Will also accept 2 years of experience in the job offered or as a related Science Professional in lieu of Bachelor’s degree. Mail resume with cover letter to Global PharmaTek, LLC, 2025 Lincoln Highway, Suite 225, Edison, NJ 08817; Job 18GPH14; EOE

Apply Job Description:

Global PharmaTek, LLC has job openings for Sr. Clinical Research Associate I. Jobs located in Edison, NJ and various unanticipated locations throughout the U.S. Identify and initiate appropriate investigational sites for clinical studies. Administer, coordinate, and monitor research projects according to guidelines and federal regulations. Maintain databases of critical patient information, draft correspondence, and gather data relevant to budgeting. Develop and write trial protocols. Travel to various unanticipated locations throughout the U.S. for long and short term assignments at client sites. Requires Master’s degree or foreign equivalent in Computer Science, Engineering (any), Business Administration, Life Sciences, or related.

Mail resume with cover letter to Global PharmaTek, LLC, 2025 Lincoln Highway, Suite 225, Edison, NJ 08817; Job 18GPH13; EOE

Apply Job Description:

Global PharmaTek, LLC has job openings for Sr. Validation Engineer I. Jobs located in Edison, NJ and various unanticipated locations throughout the U.S. Analyze validation test data to determine whether systems or processes have met validation criteria and to identify root causes of problems for various pharma and other facilities. Prepare validation and performance qualification protocols for new or modified processes, systems, or equipment for various production types. Coordinate the implementation or scheduling of validation testing with affected departments and personnel. Create, populate, and maintain databases for tracking validation activities, test results, and validate systems. Travel/relocate to various unanticipated locations throughout the U.S. for long and short term assignments at client sites. Requires Master’s degree or foreign equivalent in Regulatory Affairs, Pharmaceutical Sciences, Pharmacy, Chemistry, Biochemistry, Biology, or a related life sciences discipline.

Mail resume with cover letter to Global PharmaTek, LLC, 2025 Lincoln Highway, Suite 225, Edison, NJ 08817; Job 18GPH05; EOE

Apply Job Description:

Global PharmaTek, LLC has job openings for Process/Validation Engineer. Jobs located in Edison, NJ and various unanticipated locations throughout the U.S.Authors engineering study protocols for the vial washer, depyrogenation tunnel, vial filler, puck washer,tray loader and filter skid associated on the Abboject and Ampoule filling lines.

Reviews standard operating procedures which are related to each equipment according to 21 CFR part 11.Uploads developed protocols in the company’s record website by following the procedures.Prepares riboflavin solution in biological quality lab by following the procedure and uses on vial washer and puck washer to test spray coverage test on filling lines.Prepares biological samples to verify the sterility of the heating and cooling zones in depyrogenation tunnel.Witnesses’ vendor SAT (Site Acceptance Test) protocol and execution of all equipment associated with each filling lines.Calculates particle count at the equipment on the Abboject and Ampoule filling lines to verify if rooms are maintaining Grade A aseptic conditions.Performs smoke studies to verify the laminar flow hoods are working consistently throughout in Grade A aseptic conditions. Executes engineering study protocols and acquires required parameters which are used to perform drug production activities.Develops summary reports on executed engineering study protocols on all equipment associated with Abboject and Ampoule filling lines.  Requires Minimum Bachelor’s Degree in Pharmacy, Life sciences, Health science or a related field and relevant 1-2 years of experience.

Mail resume with cover letter to Global Pharma Tek, LLC, 2025 Lincoln Highway, Suite 225, Edison, NJ 08817; Job 16GPH19; EOE

Location: Edison, NJ

Apply Job Description:

Global PharmaTek, LLC has job openings for CMC Specialist-Regulatory Affairs.Jobs located in Edison, NJ and various unanticipated locations throughout the U.S.Operated as a member of the CMC Product team to, provide project management support for development and maintenance of timelines and collection of CMC deliverables related to preparation of Chemistry, Manufacturing, and Controls information for new product registrations or post-approval changes including annual reports, registration renewals, supplements, variations, commitments, tender bids and responses. Led the planning and creation of a detailed project plan in GRACS planning tool for CMC submissions with input from identified stakeholders and the CMC Product Lead. Managed project deliverables during all phases of submission preparation (e.g. authorization, assessment, execution and close-out) and ensured project tasks are completed against plan. Utilized and maintained GRACS and/or MMD systems to support compliant operational execution of activities related to change control and dossier preparation (GCM, RCAM, ORION, USPT, Red Compass, etc.), as needed.Led discussions and negotiated resolution of scheduling conflicts with MMD and Site/International CMC stakeholders to provide visibility to project constraints. Supported CMC scientists in collection of information to support change assessments and dossier strategy. Liaise with MMD and internal stakeholders to support compliant execution of change management and CMC business processes. Tracked project deliverables through appropriate business processes (Manufacturing Change Control Management, Content Authoring, Health Registration Management, and Regulatory Submission Planning). Conducted all activities with an unwavering focus on regulatory conformance. Identified, assessed, and communicated actively to resolve or escalate potential project challenges with the CMC Product Team and/or GRACS CMC management, as needed. Assisted in the development and continuous improvement of business processes, tools, systems, metrics and analytics under supervision of manager. Supported submission preparation and delivery under the direction of the CMC product lead and/or team members. Developed virtual document structures & metadata. Responsible for formatting, editing (e.g. grammar, spelling, and punctuation), finalizing and uploading submission related documentation into GRACS systems/tools (RCAM, USPT). Coordinated the flow of documents via document-sharing systems (e.g., SharePoint, RCAM Workflow) to ensure version control throughout the submission generation process (writing, review, and internal approval). Provided support for other CMC projects and activities, as required. Requires Bachelor’s Degree in Information Systems, or a related area and relevant 1-2 years of experience.

Mail resume with cover letter to Global Pharma Tek, LLC, 2025 Lincoln Highway, Suite 225, Edison, NJ 08817; Job 16GPH18; EOE

Location: Edison, NJ

Apply Job Description:

Global PharmaTek, LLC has job openings for Drug Safety Associate.Jobs located in Edison, NJ and various unanticipated locations throughout the U.S.Receives clinical study SAE reports, review for medical/regulatory content and assure accuracy per protocol requirements, obtaining follow up as needed; ensure that all SAE’s are complete prior to database closure Process and distributes clinical study SAE reports as per the company SOPs Completes AE/SAE reconciliation prior to clinical trial database closure Receives, processes, and distributes spontaneous adverse event reports for marketed products, both serious and non-serious, as per the company’s SOP’s .Processes all types of adverse event reports utilizing the ARIS safety database Assists with preparing and/or reviewing safety summaries for Investigator Brochures and annual reports, safety submissions for marketed products, and other safety reports as needed or requested Assists with providing safety support and training for clinical, monitoring, and clinical site personnel as needed Assists with implementing safety surveillance processes and establishing appropriate SOPs Experience. Requires a minimum of a Bachelor’s Degree in Pharmaceutical Science or a related area and relevant 1-2 years of experience.

Mail resume with cover letter to Global Pharma Tek, LLC, 2025 Lincoln Highway, Suite 225, Edison, NJ 08817; Job 16GPH17; EOE

Location: Edison, NJ

Apply Job Description:

Global PharmaTek, LLC has job openings for Document Quality Specialist. Jobs located in Edison, NJ and various unanticipated locations throughout the U.S.Responsible for Generation, maintenance including follow up for documents and finalization of Trial Master File Table of Contents. Review of client documentation with respect to content, cross-section referencing and compliance with appropriate regulations. Pre-Audit/Inspection review of Trial Master File (TMF) documentation in accordance with or client company Sop’s. Troubleshooting location of documents and assign appropriate location of files. Reconciliation and remapping of TMF.Worked with multiple client filing structures.Responsible for ensuring compliance with client and Company SOP’s. Processing client documentation into company eTMF solution. Preparation of documentation for archival, in accordance with SOP’s and industry standards.Create and maintain tracking tools to monitor collection and expiry of essential documents; work with CRO team to obtain required updates. Responsible for setting up, maintaining an ongoing basis, providing expertise in quality controlling and archiving of the global Trial Master File (TMF) (paper TMF or eTMF) – including but not limited to Study Files. Provide proactive, close support to Study Manager with quality control and verification of the TMF managed/maintained by external suppliers. Requires Minimum Bachelor’s Degree in Health Administration or closely related field, and relevant 1-2 years of experience

Mail resume with cover letter to Global Pharma Tek, LLC, 2025 Lincoln Highway, Suite 225, Edison, NJ 08817; Job 16GPH16; EOE

Location: Edison, NJ

Apply Job Description:

Global PharmaTek, LLC has job openings for Clinical Research Coordinator. Jobs located in Edison, NJ and various unanticipated locations throughout the U.S.Work in collaboration with Principal Investigator and assisting in submission of IRB Approvals, SAE Reporting, addressing and reporting protocol deviations, Track and collate clinical trial documentation related to Clinical Study Report (CSR) appendices, Review study – specific CRF and source documents, Perform Source data verification (ALCOA) of clinical data in subject binder and EDC,Addressing issues and queries of clinical team during database close (DBC) and database lock(DBL). Identification and Control of the raw material, Drug substance and ensure chemical stability. Perform Chemical analysis of biological specimens and evaluate the laboratory data, Resolving system generated and data management generated queries in EDC, Checking the accuracy of clinical documents and archiving data in subject binders according protocol guidelines, Facilitate improvement in overall quality and completeness of trial documentation through the query process along with formal and informal education, Review of listings and tables for accuracy and completeness, Assisting and facilitating data for the CRA during study monitoring visit. Updating patient visit reports in IVRS and dispensing study drug as per IVRS Reports, Ensure proper storage conditions for study drug and supplies and ensure quality control and quality assurance of drug substances, Perform proper storage and shipment of Bio-specimens along with tracking and updating data in EDC systems and subject binders. Requires Minimum Bachelor’s Degree in Pharmacy or a related field. and relevant 1-2 years of experience.

Mail resume with cover letter to Global Pharma Tek, LLC, 2025 Lincoln Highway, Suite 225, Edison, NJ 08817; Job 16GPH15; EOE Location: Edison, NJ

Apply Job Description:

Global PharmaTek, LLC has job openings for Clinical Contract Associate. Jobs located in Edison, NJ and various unanticipated locations throughout the U.S. Provide contract administration support in response to Contracts Records ,Management and Cleanup for GDAR, Apollo migration and CLMS,Reconcile contracts in Apollo and CMS, Review all executed clinical contracts saved on Apollo and CMS and perform reconciliation between the contracts that are saved in these two platforms, Scan and create Optical Character Recognition (OCR) via Adobe Acrobat for various executed contracts including CTAs, CDAs, LOAs, Vendor Agreements,Performing QC on the scanned contracts to ensure All pages of the documents are included, All required signatures are verified and present, All budget pages are legible, All pages have undergone OCR conversion, Documents have been saved in the Shared Folder in Apollo,Enter Agreement Party Information on Clinical Management System (CMS), Identify metadata for each contract,Upload contract(s) to CMS,Complete required metadata fields in CMS with contract party information. Requires Minimum Bachelor’s Degree in Pharmacy or a related field and relevant 1-2 years of experience.

Mail resume with cover letter to Global Pharma Tek, LLC, 2025 Lincoln Highway, Suite 225, Edison, NJ 08817; Job 16GPH14; EOE

Location: Edison, NJ

Apply Job Description:

Global PharmaTek, LLC has job openings for Compliance Manager (Pharma). Jobs located in Edison, NJ and various unanticipated locations throughout the U.S. Develop innovative value propositions within the clinical research and life sciences space to meet global regulatory compliance relating to pharmaceutical, bio-pharmaceutical, and medical devices manufacturing. Provide leadership and technical decision-making for various stakeholders, management, and high-level technical personnel regarding cGMP, GCP, ICH compliance, regulatory audits, strategy, clinical, and quality systems for projects and strategic activities. Author, review, and implement SOPs to ensure compliance with current international regulatory standards and cGMP. Lead cross-functional analytical teams in the resolution of business or systems issues in pharmaceutical manufacturing. Create and develop relationships with clients and identify future opportunities. Travel/relocate to various unanticipated locations throughout the U.S. for long and short term assignments at client sites. Requires Master’s degree or foreign equivalent in Computer Science, Engineering (any), Business Administration, Life Sciences, or a related scientific/quantitative discipline.

Mail resume with cover letter to Global Pharma Tek, LLC, 2025 Lincoln Highway, Suite 225, Edison, NJ 08817; Job 17GPH13; EOE

Location: Edison, NJ

Apply Job Description: Global PharmaTek, LLC has job openings for Sr. Pharmacovigilance Scientist I. Jobs located in Edison, NJ. Review non-serious and serious AEs and aggregate AE listings. Prepare signaling meeting presentations in collaboration with the team, including review of events of interest, initial trending of AEs, set thresholds for escalation, and preparation of meeting minutes. Monitor the safety profile of assigned compounds to identify any safety signals and support execution of plans for signal evaluation. Safety Committee preparation and documenting of meeting minutes. Review urgent safety issues and escalate to MD. Initial preparation of RMP and PV plans. Literature search terms and summary results review and escalation to MD. Responsible for clinical study such as IB and NDA, safety benefit-risk review, and ad hoc reports. Aggregate report review and input for assigned products such as PSURs, PBRER, PADER – triage to MD. Interact with vendor contracted to author aggregate reports for specific products, as needed. In collaboration with the team, contribute to and help coordinate responses to safety questions from regulatory authorities for assigned products. Contribute to initiatives for process improvement and consistency regarding aggregate reporting, signal management, and responding to ad hoc safety questions. Requires Master’s degree or foreign equivalent in Computer Science, Engineering (any), Public Health, Life Sciences, or related.

Mail resume with cover letter to Global Pharma Tek, LLC, 2025 Lincoln Highway, Suite 225, Edison, NJ 08817; Job 17GPH12; EOE

Location: Edison, NJ

Apply Job Description: Global PharmaTek, LLC has job openings for Sr. Validation Engineer I. Jobs located in Edison, NJ and various unanticipated locations throughout the U.S. Analyze validation test data to determine whether systems or processes have met validation criteria and to identify root causes of problems for various pharma and other facilities. Prepare validation and performance qualification protocols for new or modified processes, systems, or equipment for various production types. Coordinate the implementation or scheduling of validation testing with affected departments and personnel. Create, populate, and maintain databases for tracking validation activities, test results, and validate systems. Travel/relocate to various unanticipated locations throughout the U.S. for long and short term assignments at client sites. Requires Master’s degree or foreign equivalent in Regulatory Affairs, Pharmaceutical Sciences, Pharmacy, Chemistry, Biochemistry, Biology, or a related life sciences discipline.

Mail resume with cover letter to Global PharmaTek, LLC, 2025 Lincoln Highway, Suite 225, Edison, NJ 08817; Job 16GPH11; EOE

Location: Edison, NJ