[Hiring] PK Medical Writer @ICON plc

Role Description

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, including:

• Population PK/PD data transfer plans
• Population PK/PD analysis plans
• Population PK/PD reports
• 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.

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).
• 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

• Manage multiple projects simultaneously and prioritize tasks based on project timelines and deliverables.
• Influence decision-making processes.

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.