[Hiring] PK Medical Writer @ICON plc

Role Description

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. 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.

• 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.
• Write clear and concise documents, including study reports, protocols, 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.
• Ensure deliverables are inspection ready and compliant with relevant requirements.
• Maintain the central planning of population PK/PD document writing and QC deliverables.

Qualifications

• Advanced degree in Life Sciences, Pharmacy, Medicine, or related field.
• Minimum of 3-5 years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organization (CRO) industry.
• Proficiency in interpreting and summarizing complex clinical trial data, scientific research findings, and statistical analyses.
• Excellent writing, editing, and proofreading skills.
• Ability to communicate scientific concepts to diverse audiences.
• Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) governing the preparation and submission of clinical documents and publications.
• Experience in interacting with regulatory agencies during the review and approval process.
• Demonstrated ability to work effectively in a fast-paced, deadline-driven environment.
• Excellent interpersonal and communication skills.
• Ability to collaborate effectively with cross-functional teams and build relationships with key stakeholders.

Requirements

• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Benefits

• Competitive base salary and performance related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.
• Benefits may vary depending on role and location.

Company Description

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.