Documentation & Regulatory Writing Jobs

ABOUT THE ROLE Role Description: Amgen Research’s Semantic Graph Team is seeking a dedicated and skilled Sr Software Engineer with semantic technologies experience to maintain, operate, and enhance th

HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming

ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases and make people’s lives easier, fuller, and longer. We discover, develop, manufacture, and deliver

ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver

Job Responsibilities . · Completion of assigned projects as per timelines · Adhering to process SOP · Timely completion of documentation · Adhering to safety risk compliance · Executions of all proces

Summary of Responsibilities: Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirem

Major Purpose of the Job: -To develop cost effective and robust process of API. Principal Tasks and Responsibilities: -To develop chemical process which is having least hazardous chemicals and cost

"JOB RESPONSIBILITIES • Review of Literature summary report, patent summary report and development protocols. • New product development, Planning and Resource allocation for Domestic, ROW, US, EU, C

Method development, validation & transfer of different analytical chromatography methods. - Characterization of products on LCMS - Coordination with vendors for external characterization studies and

Medical Writer Major purpose of the Job : -As a primary role Medical writing activities for BE and CT studies includes Preparation of Protocol, ICF, CRF and Clinical study report and as a secondary

Principal task: 1) Monitoring Analytical method development, Validation study and method transfer activities. 2) Review the analytical method development data, validation study data and method trans

JOB RESPONSIBILITIES 1. Preparation of New product documents and Routine Revision of Raw Material Specifications and Standard Test Procedures for Export, Regulatory agency and Domestic market. 2. P

hands on experience in API Synthesis

"JOB RESPONSIBILITIES • Review of Literature summary report, patent summary report and development protocols. • New product development, Planning and Resource allocation for Domestic, ROW, US, EU, C

The major purpose of a Clinical Research Associate (CRA) is to ensure that clinical trials to be conducted in compliance with regulatory requirements, ethical standards, GCP and the study protocol.

JOB RESPONSIBILITIES • Routine HPLC Analysis for Raw Material, Intermediate, in process and Final API as per the Specification and Standard test procedure. • Developed New HPLC Method for all stage

Principal task and Responsibilities: 1) Analytical Method Development by HPLC for all Project. 2) Routine HPLC Analysis for Raw Material, Intermediate, in process and Final API as per the Specifica

•Preparation of Artworks for various components for Domestic, ROW, EU and USA markets. •Hands on various software i.e. Adobe Illustrator, Coral draw, Photoshop, InDesign. •Preparation of Cutter guide

1. Understanding the process in details with concerned scientist with experiments in the lab. 2. Study the operational parameters of different operations like crystallization, distillation, drying and

Responsibility  Lab demonstration & scale up of new DMF and NDMF molecules, Process Optimization before Scale-up activities, Execution of Kilo Lab batches & technology transfer activity. Principal Ta