Principal Medical Writer At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide. We are currently seeking Senior or Principal Medical Writer to join our diverse and dynamic team. At this role you will be responsible for leading the development of high-quality regulatory and clinical documents that effectively communicate scientific and medical information. Your expertise in medical writing will be crucial in supporting our clients’ submissions to regulatory authorities and ensuring compliance with industry standards. We hire at Medical Writer 2, Senior Medical Writer or Principal Medical Writer level What You Will Be Doing: Guides medical writing document preparation, including coordination of assignments to writers, review, and substantive editing of documents. As necessary, may assume primary responsibility for preparation of key regulatory response documents and documents supporting major regulatory submission. Formulates writing approach, develops timelines, and assesses resource requirements for key documents and regulatory submissions within designated therapeutic or functional area. 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, including international regulatory guidance and requirements for content and format, work requirements (style, electronic integrity, and process), and project- or therapeutic area-specific guidance related to content and organization of specific documents. 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, ensuring consistency of content within therapeutic areas and adherence to regulatory requirements and Sponsor requirements and processes across development programs. Represents Medical Writing on cross-functional teams and task forces (related to projects, process, and standards). 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. The Principal Medical Writer is seen as an expert in medical writing and performs work independently with minimal supervision. Your Profile: Bachelor’s degree in science, health profession required At least 5 years of experience writing for pharma or biotechnology preferred . 3+ years of electronic documents and submissions required. Experience with writing key documents included in major international regulatory submissions required like Clinical study reports, IBs, Protocols Experience managing writing activities for a major international regulatory submission preferred. Knowledge and Skills: Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products. Understanding of international regulations, ICH guidelines, and applicable international regulatory processes related to document preparation and production (including CTDs). Well-developed oral and written communication skills; ability to clearly present technical information within and across functional areas. Demonstrated problem-solving and interpersonal skills that facilitate effective interactions within functional and cross-functional teams and with external providers #LI-NR1 #LI-Remote Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. 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 Benefits may vary depending on role and location. Visit our careers site to read more about the benefits ICON offers. Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here. Are you a current ICON Employee? Please click here to apply ICON is an award-winning workplace that enables you to make a difference to patients’ lives by being part of a world-class clinical research organisation that helps deliver new medicines & medical devices that are benefitting patients worldwide. You are also part of a diverse company that cares about our world and is dedicated to conducting business more sustainably and supporting the communities in which we live. If you’re as driven as we are, join us. You’ll be working in a great environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry. Didn’t find the role you were looking for? Even if the perfect role isn’t available right now, we’re always excited to connect with talented individuals. Register to our Talent Community to receive updates on roles that align with your career goals.

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