Assistant Manager, Clinical Services

Job description Job Details Job Description To author, review, and independently manage high-quality clinical documents: Clinical Study Reports (CSR) including narratives, Protocol, and Informed Consent Form (ICF), Investigator Brochure. Review and Preparation of regulatory documents as per country-specific regulatory requirements. Clinical Trial Documents (CTD) Modules (2.4, 2.5, 2.6, 2.7) Excellent skillset in literature search, understanding of PICOS criteria and PRISMA statement 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 other ICH and regulatory guideline required for drug development. 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. What Cencora offers Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements. Full time Affiliated Companies Affiliated Companies: PharmaLex India Private Limited Equal Employment Opportunity Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned Role: Healthcare & Life Sciences - Other Industry Type: Medical Services / Hospital Department: Healthcare & Life Sciences Employment Type: Full Time, Permanent Role Category: Healthcare & Life Sciences - Other Education UG: Any Graduate PG: Any Postgraduate Key Skills TrainingPharmacyLegalLife sciencesPharmacologyManagementStatisticsICHData interpretationRecruitment