PK Medical Writer - India - Remote
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 creative 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 Sci
📌 PK Medical Writer (Bengaluru)
🏢 IRE
📍 Bengaluru