Parexel
b' Job Purpose: With appropriate departmental supervision, the Associate Medical Writer will prepare clinical documents of low complexity and may provide writing support for more complex clinical documentation. Under departmental supervision, the Associate Medical Writer will provide technical and administrative…
b' Job Purpose: The Site Care Partner II (SCP II) is the \xe2\x80\x9cface of the client\xe2\x80\x9d and therefore accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and client\xe2\x80\x99s reputation is upheld throughout study lifecycle. The…
India, Remote Job ID R0000017927 Category Clinical Trials ABOUT THIS ROLE TMF Support Collaborates with the TMF Inspection Readiness Specialist to plan and execute assigned tasks. Maintains overview of the agreed planning, proactively providing status updates and notifying trends to…
Regulatory Affairs Associate 2 to 5 years of experience in Regulatory Affairs CMC, should be willing to work in EU Shifts. To understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large…
Hyderabad, India Job ID R0000014569 Category Human Resources ABOUT THIS ROLE The Recruiter responsible for candidate management and pipeline build up of for various aligned requisitions through active candidate sources i.e JOB BOARDS/social media/ERP/Direct/ Head Hunting etc. The Recruiter works…
India, Remote Job ID R0000011229 Category Data Management ABOUT THIS ROLE Key Accountabilities: Accountability Supporting Activities Set Up, Maintain, Revise, Close Out Electronic Data Capture Systems Lead and supervise and/or create, implement and execute procedures to build and maintain database…
Trainee Medical Writer Job Description: Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize low complexity documents, such as patient narratives, public disclosure documents, and simple aggregate safety reports (e.g., Periodic Adverse Drug Experience Report [PADERs]), under…
Associate Medical Writer Basic experience/understanding of Clinical Trial Disclosure/Clinical Trial Transparency. The candidates with the below experience would be preferred. Experience handling regulatory websites such as ClinicalTrials.gov, EudraCT/ Clinical Trials Information System (CTIS), and European Union electronic Register of Post…
1. 2 4 yrs of experience in a regulatory environment with preference given to drug/device/biologic related industry, and experience with electronic publishing of regulatory submissions. 2.Compilation, publishing, and technical quality control of Regulatory submissions (Nees, paper and eCTD format) including…
Job Purpose: Under departmental supervision, the Senior Medical Writer will research, create, edit, and coordinate the production of PBRER/PSUR for submission to regulatory authorities. The Senior Medical Writer would serve as the primary client contact. The Senior Medical Writer must…
Key Accountabilities Timely preparation of accurate and competitive Clinical Study grants (Phases I IV for all clinical indications) via proficient usage of any Clinical Study Pricing Tool that PAREXEL is required to use to support our clients\' needs. The default,…
The Clinical Supply Specialist (CSS) will support the Clinical Supply Leader with the development and applying the study specific supply chain strategy incl. the sourcing and distribution strategy and the technical management for Clinical Trial Supply and Logistics projects. The…
Job Description: Experience with Maintenance regulatory applications in international markets or US and Canada Expertise in supporting CMC Major/ Minor Variations, Renewal and RTQs, M1 Authoring Knowledge of different tools such as Veeva Vault, Veeva RIM, etc May serve as…
Key Accountabilities: Project Execution: Works effectively within a team environment Works within broad project guidelines as directed by the Project Lead or Technical SME With the guidance of the project Technical SME, demonstrates the ability to prioritize work to achieve…
The Supplies & Logistic Leader (SLL) acts as functional leader and will provide global leadership, management, general oversight and direction for Clinical Trial Supply & Logistics (CTS&L) projects. This requires in depth business understanding in order to make effective decisions…
Key Accountabilities: Project Administration: Under supervision provide basic paper and electronic publishing services including document preparation, legacy conversion, scanning, rendering, bookmarking, hyperlinking, compilation, table of contents creation, volumization, pagination, and formatting of reports and simple submissions. Provide basic regulatory affairs…
Key Accountabilities: Project Administration: Under supervision provide basic paper and electronic publishing services including document preparation, legacy conversion, scanning, rendering, bookmarking, hyperlinking, compilation, table of contents creation, volumization, pagination, and formatting of reports and simple submissions. Provide basic regulatory affairs…
Parexel\'s Regulatory Medical Writing Services works closely with our clients around the world to develop and launch new medicines and treatments that improve healthcare for millions of patients. We\xe2\x80\x99re one of the largest providers of medical writing services worldwide, and…
Everything we do has the potential to impact patient lives, and our Clinical Research Associates (CRAs) take their work seriously, demonstrate empathy, and act with heart. They also perform with urgency, navigating our streamlined clinical operating model to drive effectiveness,…
Everything we do has the potential to impact patient lives, and our Clinical Research Associates (CRAs) take their work seriously, demonstrate empathy, and act with heart. They also perform with urgency, navigating our streamlined clinical operating model to drive effectiveness,…
Provide safety technology support to internal and external safety users and analysts, including the analysis of problems, through to the implementation of solutions. Participates in initiatives in the administration, integration, implementation, vali Provide safety technology support to internal and external…
Job Purpose: The Sr. Scientist is recognized as a subject matter expert and provides scientific leadership in at least one discipline of Biomarkers and Genomic Medicine. The Sr. Scientist develops strong client relationships and works closely with cl Job Purpose:…
Experience: Minimum 2 years of medical writing/aggregate experience * Role: Medical Writer II * Location Hyderabad/Mohali/Chandigarh/Homebased * Job Purpose: Under departmental supervision, the Medical Writer will research, create Experience: Minimum 2 years of medical writing/aggregate experience Role: Medical Writer II…
Experience: Minimum 2 years of medical writing/aggregate experience * Role: Medical Writer II * Location Hyderabad/Mohali/Chandigarh/Homebased Job Purpose: Under departmental supervision, the Medical Writer will research, create, edit, Experience: Minimum 2 years of medical writing/aggregate experience Role: Medical Writer II…
Job Purpose: * Provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products * Signal detection/analysis/evaluation an Job Purpose: Provide medical review, analysis and…
Experience: Minimum 2 years of medical writing/aggregate experience * Role: Medical Writer II * Location Hyderabad/Mohali/Chandigarh/Homebased Job Purpose: Under departmental supervision, the Medical Writer will research, create, edit, Experience: Minimum 2 years of medical writing/aggregate experience Role: Medical Writer II…
In Parexel FSP we are currently looking for a Site Relationship Partner based in Mumbai, India. Position Purpose: The Site Relationship Partner (SRP) is the main Client point of contact for investigative sites, responsible for building and retaining relationships from…
In Parexel we are currently looking for a Country Trials Manager based in Mumbai, India . Position Purpose: The Country Trials Manager (CTM) is responsible for study startup deliverables for assigned studies at a country level of limited or moderate…
As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or…
Accountabilities: Demonstrates full competence when conducting the following tasksDevelopment of database build specificationsDevelopment of data validation specificationsTest data creation & UATPerforming/ leading functional QC activities and testingCreate CRF Completion Guidelines (CCG), SAE reconciliation Guidelines, etc.Data validation and cleaningConduct medical coding…
Key AccountabilitiesAssume the ability to meet the requirements of a CDA I and II with a high degree of proficiency and autonomyAct as an independent CDM Coordinator on complex or multiple projects, CMA/CDA Coordinator on smaller projectsManage all phases of…
As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or…
Parexel's Regulatory Medical Writing Services works closely with our clients around the world to develop and launch new medicines and treatments that improve healthcare for millions of patients. We’re one of the largest providers of medical writing services worldwide, and…
As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or…
Job Purpose: The Senior Clinical Data Analyst (SCDA) independently performs/lead and/or coordinate all clinical data validation activities on assigned projects, commensurate with experience and/or project role, with high degree of proficiency and autonomy. Further responsibilities shall include providing technical expertise…