# Medical Writer II **Company**: ICON **Work arrangement**: remote **Experience**: senior **Category**: Healthcare **Industry**: Healthcare **Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/UK-Swansea/Medical-Writer-II_JR159848?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_5d56b7bc-8e0 ## Description ICON is seeking a Senior or Principal Medical Writer to join their diverse and dynamic team. As a Medical Writer II, you will be responsible for leading the development of high-quality regulatory and clinical documents that effectively communicate scientific and medical information. **Responsibilities:** - Guides medical writing document preparation, including coordination of assignments to writers, review, and substantive editing of documents. - Formulates writing approach, develops timelines, and assesses resource requirements for key documents and regulatory submissions. - Participates on relevant project teams and task forces, and provides functional and cross-functional guidance on a wide range of issues related to document preparation. - Leads the writing strategy providing expertise including organization, content, timelines, and resource requirements. - Provides more complex advanced input for study designs, analysis plans, sections of INDs and marketing applications. - Provides review and substantive editing of contributions, and ensures resolution of issues. - Within designated therapeutic or compound function, manages deliverables and preparation of documents for submission to regulatory agencies. - Represents Medical Writing on cross-functional teams and task forces. - Acts as a key Medical Point of contact for clinical regulatory strategy. - As required, serves as lead writer for important regulatory response documents and key components of regulatory submissions. - Provides leadership on functional teams that address requirements or issues related to document preparation and production. **Requirements:** - Bachelor’s degree in science, health profession required. - At least 3 years of experience writing for pharma or biotechnology preferred. - Experience with writing key documents like Clinical study reports, IBs, Protocols. - Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment. - Understanding of international regulations, ICH guidelines, and applicable international regulatory processes related to document preparation and production. - Well-developed oral and written communication skills. - Demonstrated problem-solving and interpersonal skills. **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. ## Skills ### Required - medical writing - clinical development - regulatory submissions - document preparation ### Nice to have - electronic documents and submissions - study designs - analysis plans - INDs and marketing applications --- Source: [Apply at icon.wd3.myworkdayjobs.com](https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/UK-Swansea/Medical-Writer-II_JR159848?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)