Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!
Job Details
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
7-12 years of experience in core medical/regulatory writing
Ability to manage multiple projects and meet tight deadlines.
Attention to detail and strong analytical skills.
Excellent written and verbal communication skills
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.
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