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.
The purpose of this role is to deliver high-quality, relevant Clinical Pharmacology & Pharmacometrics (CPP) documents, such as 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.
Responsibilities include:
- Writing clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documents
- Driving the document preparation process, receiving and reviewing primary statistical output, drafting and distributing documents for review, and incorporating/resolving comments with all reviewers
- Providing scientific and medical writing consultancy to project teams, as requested
- Ensuring deliverables are inspection-ready and compliant with relevant requirements
- Maintaining the central planning of population PK/PD document writing and QC deliverables
Requirements:
- Advanced degree in Life Sciences, Pharmacy, Medicine, or related field, with a minimum of 3-5 years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organisation (CRO) industry
- Proficiency in interpreting and summarising complex clinical trial data, scientific research findings, and statistical analyses, with excellent writing, editing, and proofreading skills, and the ability to communicate scientific concepts to diverse audiences
- Strong understanding of regulatory requirements governing the preparation and submission of clinical documents and publications, and experience in interacting with regulatory agencies during the review and approval process
- Demonstrated ability to work effectively in a fast-paced, deadline-driven environment, managing multiple projects simultaneously and prioritising tasks based on project timelines and deliverables
- Excellent interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams, build relationships with key stakeholders, and influence decision-making processes
Benefits may include:
- 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