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Current Openings

Regulatory Affairs II

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Job Description:

Green Pharma Tek, Inc has job openings for Regulatory Affairs II. Jobs located in Edison, NJ and various unanticipated locations throughout the U.S.This position is responsible for the management and delivery of regulatory submissions to global health authorities required to support the maintenance, development and registration of products.Depending on the particular project and assigned submission(s), required activities may include, but may not be limited to: Establishing Dossier Plans for the assigned Global submission types as needed to support the lifecycle of one or more products.The candidate will be responsible for: 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.Required minimumBachelor’s Degree in Pharmaceutical Science or a related area and 1 – 2 years of relevant experience.

Mail Resume with cover letter at 2025 Lincoln Highway, Suite 350 Edison, New Jersey 08817, USA.

Location: USA

Clinical Trial Associate

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Job Description:

Green Pharma Tek, Inc has job openings for Clinical Trial Associate. Jobs located in Edison, NJ and various unanticipated locations throughout the U.S.Supporting CPMs with various study start-up activities, including trackinginvestigator site feasibility status, essential document review for the site initiationand investigational product release and enrollment; Coordinating clinical document management activities for multiple studiesincluding management of electronic trial master files (eTMF);Performing periodic ad hoc, interim and end-of-study reviews/audits on paper andelectronic TMFs for several trials to ensure TMF meets sponsor’s expectations(includes TMF reconciliation at study close-out);

Performing TMF QC for Contract Research Organization (CRO) TMF andensuring quality of the TMF;Providing TMF related queries to responsible personnel and resolving the issues Within stipulated timelines;Assisting in the management of Contract Research Organizations (CROs),vendors and contractors to ensure that the study requirements are met;Liaising between CRO and Sponsor for study and TMF related activities;Assisting CPMs as required to ensure the successful completion of the study;Attending study and vendor meeting, taking meeting minutes and preparingagendas; andParticipating and supporting mock FDA inspection by retrieving and providingrequested documents, from the TMF.Required at least a Bachelor’s Degree in Healthcare Administration, or a related area&1 – 2 years of relevant experience.

Mail Resume with cover letter at 2025 Lincoln Highway, Suite 350 Edison, New Jersey 08817, USA.

Location: USA

Associate Scientist R&D

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Job Description:

Green Pharma Tek, Inc has job openings for Associate Scientist R&D. Jobs located in Edison, NJ and various unanticipated locations throughout the U.S.This is a Center Research-based technical leadership role providing direction for and execution of projects across one or more of our North American businesses.The candidate will be scoping and/or executing technical projects to meet business initiatives focused on Product Engineering.Strongunderstanding of Design of Experiments. Adapt and apply scientific principles to new situations/products.Manage multiple assignments/research projects concurrently.Specification creation and updating, with attention to detail.This includes designing and executing tests, analyzing data,drawing conclusions, documenting, communicating results, and commercializing products. Communication and teamwork skills are essential in this role, which operates in a dynamic and cross-functional environment.The candidate must also have a technical background and be able to apply prior learning or scientific principles to newsituations.This position requires an individual to manage multiple assignments/ tasks concurrently with moderate levels of supervisor guidance. Exhibiting a collaborative mindset and applying innovative solutions are a must. Required Minimum Bachelor’s Degree in Biotechnology or a related field and Minimum 1 – 2 years of relevant experience.

Mail Resume with cover letter at 2025 Lincoln Highway, Suite 350 Edison, New Jersey 08817, USA.

Location: USA

QC Analyst

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Experience: 2-3 years

Experience: Bachelors/Masters

Job Description:

  • All separation techniques HPLC, Capillary Gel Electrophoresis, SDS-PAGE, ICP-MS.
  • Repetitive bending and reaching to setup and break-down equipment·
  • Ability to work around chemicals
  • Prefer GMP experience
  • Analyze samples using specific procedures and instrumentation.
  • Maintain documentation.
  • Recognize specification ranges.
  • May provide assistance in troubleshooting results outside of predefined specifications.

Location: USA

Clinical Data Manager

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Experience: 5 – 6 years

Qualification: Bachelors in Life Sciences

Description:

  • Experience with web-based Electronic Data Capture and CDM applications.
  • Good working knowledge of ICH, FDA, and GCP regulations and guidelines
  • Strong well-rounded technical skills
  • Knowledge of industry standards (CDISC, SDTM, CDASH)
  • Proven ability to work both independently

Location: USA

Regulatory Affairs

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Experience: 3-5 years

Qualification: M.S

Description:

  • Assist in project management of NDA/IND activities
  • Provide regulatory support to clinical trial teams
  • Complete submissions to FDA in collaboration with the Regulatory leads
  • Collect, coordinate, and prepare regulatory documentation for submission to regulatory agencies or to development partners.
  • Maintain regulatory files/database and chronologies in good order.

Location: USA

Development Specialist I

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Experience: 3 – 5 years

Qualification: B.S and/or M.S

Description:

  • Candidate will be responsible for the design/execution of experimental procedures required for the development of robust formulations for biologics drug substance and drug product throughout their product lifecycle.
  • Closely with members of the Formulation Development and Analytical Development groups.
  • Works directly with other scientists, analytical staff, and quality groups
  • Responsible for the completion of pre-formulation and formulation experiments leading to the improvement of long-term stability of proprietary biologics drug substance and product
  • Familiar with the development of freeze-dried formulations of biologics

Location: USA

Compliance Manager

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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: USA

Sr. Pharmacovigilance Scientist I

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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: USA

Senior Validation Engineer I

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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 16GPH14; EOE

Location: USA