1. Should have experience in eCTD, NeeS and paper formats. 2. Working experience in all major emerging countries (EU, GCC, US, ASEAN etc.) 3. Compilation, publishing, and technical quality control of Regulatory submissions including technical troubleshooting to ensure issues with submissions are resolved and deadlines met. 4.Should have experience in handling submission g

An exciting opportunity for Facilities Coordinator to join the Corporate Real Estate & Services (CRES) team. Do you have experience of working within a building services environment, excellent communication skills together with a professional customer service approach then we would like to hear from you! This position will be based at Parexel's Early Phase Unit in Berlin.

Key Accountabilities Deliver best value and high quality service. Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/Guidelines, ICH GCP and/or other international regulatory requirements are performed. Assist in the coordination of pro

Under departmental supervision, the Medical Writer will research, create, edit, and coordinate the production of PBRER/PSUR for submission to regulatory authorities. The Medical Writer would serve as the primary client contact. The Medical Writer must have minimum 3 years of experience in authoring or supporting PBRER/PSUR Key Accountabilities Accountability Supporting Ac

Design and develop systems and data integrations using MuleSoft Anypoint Platform. Design and develop high quality APIs and Integrations. Develops unit tests and provides code coverage to accurately testing business logic and functionality. Creates high level design documents, including MuleSoft functionality. Support and fine tune existing integration architecture and co

Prepare liquid and solid formulations Assist with shipping, handling, and dispensing of materials Assisting with operating and maintaining compaction simulators and other instruments Assisting in maintaining a safe laboratory work environment Characterization of crystalline and amorphous phases in pharmaceutical products Documentation and reporting of results to a senior

CRO GCP SOP SDV) IRB 4 / MR/CRC//// 202381

Senior Regulatory Affairs Associate must understand the organization's consulting models and methodologies, as well having as good knowledge of what services PC provides. The Senior Regulatory Affairs Associate must have good technical skills and may be developing specialist knowledge of a particular subject and/ or market. This key role in the organization ensures the ti

Senior Site Feasibility Liaison1 Clinical Operations Leader 1 Web CRO / 1

Are you currently a non First in Human (FIH), Principal Investigator (PI)? Are you looking for a development opportunity to become PI, (FIH)? We have an exciting opportunity for a PI whose primary responsibility will be to provide medical support for human volunteer studies of new and existing pharmaceuticals performed in an Early Phase Clinical Unit (EPCU) in Harrow. We

We're looking for Study Recruiter to join our team, do you have excellent communication skills together with a professional customer service approach, a desire to work in a clinical environment and enthusiasm to learn? We would like to hear from you as full training can be given. Key Accountabilities Must have good attention to detail Proven experience of working within s

Die Parexel Early Phase Clinical Unit unterstutzt die Entwicklung innovativer neuer Medikamente, mit Fruhphasen und First in Human" Studien. Diese sind der erste Schritt zur Erprobung neuartigen Behandlungen am Menschen um deren Resultate zu verbessern. In der Parexel Berlin Unit (auf dem Gelande der DRK Kliniken Berlin Westend) sind unsere hochqualifizierten und erfahren

Due to a growing portfolio, we are currently looking for Project Quality and Risk Leads to be based in Serbia, Croatia or Turkey with flexible working hours. The Project Quality and Risk Lead assumes the lead (with support of LM or Mentor) of Quality oversight responsibility and partners with operational delivery teams focusing on first time quality, robust risk and issue

We are now looking for a Contracts Specialist to be based in Romania (the role can be based in our office in Bucharest or home based anywhere in Romania). In this role, you will amend, negotiate and finalise project budgets together with creating draft contractual documents. You will have the opportunity to work closely with colleagues across various departments such as F

Demonstrates full competence when conducting the following tasks Development of database build specifications Development of data validation specifications Test data creation & UAT Performing/ leading functional QC activities and testing Create CRF Completion Guidelines (CCG), SAE reconciliation Guidelines, etc. Data validation and cleaning Conduct medical coding if assig