PK Medical Writer - India - Remote

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

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 cutting-edge 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 minimum of 3-5 years of experience in medi

📌 PK Medical Writer (India)
🏢 ICON Strategic Solutions
📍 India