Assistant Manager, Clinical Services

Job description To author, review, and independently manage high-quality clinical documents: Clinical Study Reports (CSR) including narratives, Protocol, and Informed Consent Form (ICF). Review and Preparation of regulatory documents as per country-specific regulatory requirements. Clinical Trial Documents (CTD) Modules (2.4, 2.5) Contribute to the planning of data analyses and presentations to be used in CSRs; Ensure compliance with documentation Excellent data interpretation skills. Understanding of ICH-E6 and E3 guideline. Understanding of template for Protocol as per ICH-E6 and Transcelerate Common trial protocol Basic understanding of statistics Relevant Experience and Education Postgraduate in Pharmacy (Pharmacology), Life Sciences, PharmD 7-12 years of experience in core medical/regulatory writing Excellent communication skills Ability to manage multiple projects and meet tight deadlines. Role: Healthcare & Life Sciences - Other Industry Type: Medical Devices & Equipment Department: Healthcare & Life Sciences Employment Type: Full Time, Permanent Role Category: Healthcare & Life Sciences - Other Education UG: Any Graduate PG: Any Postgraduate Key Skills TrainingLegalLife sciencesPharmacologyManagementStatisticsICHData interpretationRecruitment