Medical Writer

🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥📝 Medical Writer

👻 Ghost score 10%

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Lead the development and execution of medical writing strategies for clinical research projects • Deliver high-quality Clinical Pharmacology & Pharmacometrics documents, including population PK/PD data transfer plans, population PK/PD analysis plans, and population PK/PD reports • Prepare clinical study reports for Phase 1 healthy volunteer trials and clinical pharmacology trials • Prepare protocols for healthy volunteer studies • Prepare Module 2.7.1 and 2.7.2 documents • Write 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 • Incorporate and resolve comments with all reviewers • Provide scientific and medical writing consultancy to project teams • Ensure services adhere to client SOPs, WIs, policies, local regulatory requirements, and ICH-GCP • Communicate with clinical pharmacology and pharmacometrics leaders and other team members • Ensure deliverables are inspection ready and compliant with relevant requirements • Maintain central planning of population PK/PD document writing and QC deliverables

🎯 Requirements

• 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, including ICH-GCP, FDA, and EMA • Experience interacting with regulatory agencies during the review and approval process • Ability to work in a fast-paced, deadline-driven environment • Ability to manage multiple projects simultaneously and prioritize tasks based on project timelines and deliverables • Excellent interpersonal and communication skills • Ability to collaborate effectively with cross-functional teams, build relationships with key stakeholders, and influence decision-making processes • Legal right to work in India

🏖️ 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