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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 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

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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

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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

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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

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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

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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

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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

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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

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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