Manager, Medical Writing
UK
PRA Health Sciences
Req #: 119084
Type: Spain
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Overview: As a Manager Medical Writing you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. OBJECTIVES: Leads project teams responsible for complex writing activities and resourcing within a therapeutic or functional area. In collaboration with the therapeutic area head, ensures the development of appropriate and consistent global writing strategies for key response documents and regulatory submissions across the designated therapeutic or functional area. As necessary, may assume primary responsibility for overseeing key regulatory response documents and documents supporting major regulatory submission; in this role, guides medical writing activities including coordination of assignments to writers, review and substantive editing of documents. Responsible for managing writing activities including project and people management, and management of resources within therapeutic area. Responsibilities: What you will be doing: Represents medical writing to management with respect to development and application of standards, process (including timelines for documents or submissions), and resource requirements for key documents and regulatory submissions within the designated therapeutic or functional area. Participates as appropriate on relevant project teams, task forces, and management teams, related to document preparation and production, including US and international regulatory guidance and requirements for content and format, and project- or therapeutic area-specific guidance related to content and organization of specific documents. Manages, coaches, and guides development of direct reports, and effectively delegates and intervenes as required, to maintain optimal productivity of the teams comprising therapeutic or functional areas of responsibility. * Takes responsibility for guiding complex medical writing activities (including document preparation and/or production) for designated therapeutic or functional area. * Guides formulation of global writing strategies for key response documents and regulatory submissions, including organization, content, timelines, and resource requirements; * As required, may direct the preparation or production of important regulatory response documents or key regulatory submissions; in that role, coordinates the activities of staff, provides review and substantive editing of contributions, and ensures resolution of issues. * Provides oversight in the preparation of documents for submission to FDA or other regulatory agencies, ensuring consistency of writing strategy across therapeutic areas and adherence to regulatory requirements and Sponsor-specific requirements and processes across development programs * Represents Medical Writing on cross-functional teams, task forces, and management teams. * Provides leadership on functional teams that address requirements or issues related to document preparation and production. * Formulates effective recruitment strategies for employees and contractors within the designated therapeutic or functional areas #LI-NR1 #LI-Remote Qualifications: You are: * Bachelor's degree in science, health profession, or journalism. * At least 5-7 years experience writing for pharma or biotechnology. * Experience as lead writer for key documents included in major US and international regulatory submissions. * Experience managing writing activities for a major US or international regulatory submission (project or people management). * Clear understanding of global 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. * Clear understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs). What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs * Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead * Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
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