Pk Medical Writer

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/886jur

PK Medical Writer ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. As a Senior Medical Writer at ICON, you will lead the development and execution of medical writing strategies for clinical research projects, contributing to the advancement of innovative treatments and therapies.
Purpose Deliver high quality relevant Clinical Pharmacology Pharmacometrics (CPP) documents (e.g. population PK/PD data transfer plans, population PK/PD analysis plans and population PK/PD reports), as well as CSRs, protocols, and other documents, within the required regulatory system per global aligned procedures of the client.
Documents that the writer will be doing include CSRs for phase 1 healthy volunteer trials and clinical pharmacology trials. Protocols for healthy volunteer studies. Module 2.7.1 and 2.7.2.




Expectations Write clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documents. Drive the document preparation process, receive and review primary statistical output, draft and distribute documents for review, and incorporate/resolve comments with all reviewers. Provide scientific and medical writing consultancy to project teams, as requested.
Deliverables Services rendered will adhere to applicable client's SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc. Clear communication with clinical pharmacology pharmacometrics leaders and other team members. Ensure deliverables are inspection ready and compliant with relevant requirements. Maintain the central planning of population PK/PD document writing and QC deliverables.
Your profile Advanced degree in Life Sciences, Pharmacy, Medicine, or related field, with a

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/886jur