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Specialist Study Management
Location: Edison, NJ
Requirement: Bachelors in Regulatory Affairs, Healthcare Informatics, or closely related fieldsand relevant 1-2 years of experience.
- Assist in coordination and administration of clinical studies from the start-up to execution and close-out.
- Collect, assist in preparation, review and tracking of documents for the application process (RA/IEC). Interface with Investigators, external service provider and CRAs during the collection process to support effective delivery of a study and its documents. Serve as local administrative main contact and work closely with CRAs and/or the LSTL until finalization of the study.
- Additionally, obtain a list of central/ local IRB sites and central/local Laboratory lists from the site activation team specialist to determine the kind of IRB and laboratory documents.Operational responsibility to set-up the local Trial Master File (eTMF) and ISF including tracking of documents. Maintain and close the local TMF (in electronic or paper form depending on study) ensuring International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) in compliance with US Public Health policies and federal laws. Support the CRA in the maintenance and close out activities for the ISF.
- To ensure facilities/ labs are authenticated with mandatory licenses and to make sure that they are always valid.Performed key processing skills that include project management and teamwork skills such as gathering analysing interpreting and reporting data and archiving information in repository database.
- Contribute to the production and maintenance of study documents, ensuring template and version compliance. Translate or give the appropriate support with the translation of documents when required.
- Analysed qualitative and quantitative subject data to assure that the aim of research is obtained and to assure that researches are being performed ethically.
- 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 AstraZeneca Authoring Guide for Regulatory Documents to support publishing in ANGEL
- Set-up, populate and accurately maintain information in AstraZeneca tracking and communication tools (e.g. IMPACT, SharePoint etc) and support others in the usage of these systems
- Manage and contribute to coordination and tracking of study materials and equipment. Ensure the completeness and collection of the following documents at COV
- Coordinate administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs
- Collected culminative subject data is interpreted in the form of biostatistics which helps in determining the study design going forward.
- Responsible for printing and distribution of documents such as letters and meeting minutes, and for handling and archiving of study related e-mails
- Additional country-specific tasks depending on country need (Responsible for QA of paper and electronic TMF documents, indexing, uploading and approval of TMF documents via electronic system, maintenance of BOX to facilitate management of documents from Study teams).
- Create reports and contribute to coordination and tracking of study materials and Equipment
Lead Clinical Research Associate
Green Pharma Tek, Inc. has job openings for Lead Clinical Research Associate. Jobs located in Edison, NJ. 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. Perform research on and oversee operational activities of clinical trials regarding gastrointestinal and hematology therapeutic areas for diseases such as ulcerative colitis and congenital TTP. Provide oversight of clinical CRO investigator background checks, essential documents for investigational medicine release, and clinical CRO activities for amendments to confidentiality and site agreements. Plan and conduct investigator meetings. Monitor visit reports for oversight and escalate to clinical project manager. Requires Master’s degree or foreign equivalent in Computer Science, Engineering (any), Business Administration, Life Sciences, Public Health, or related. Offered salary $143,000 P/Y.
Mail resume with cover letter to Green Pharma Tek, Inc, 2025 Lincoln Highway, Suite 225B, Edison, NJ 08817; Job 19GPT08
Location: Edison, NJ
Green Pharma Tek, Inc 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 Green Pharma Tek, Inc, 2025 Lincoln Highway, Suite 225B, Edison, NJ 08817; Job 17GPH13; EOE
Location: Edison, NJ
Sr. Pharmacovigilance Scientist I
Green Pharma Tek, Inc 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 Green Pharma Tek, Inc , 2025 Lincoln Highway, Suite 225B, Edison, NJ 08817; Job 17GPH12; EOE
Location: Edison, NJ
Senior Validation Engineer I
Green Pharma Tek, Inc 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 Green Pharma Tek, Inc, 2025 Lincoln Highway, Suite 225B, Edison, NJ 08817; Job 16GPH14; EOE
Location: Edison, NJ