PRA Health Sciences
US National – Telecommute
Sr Manager, Medical Writing
Job Locations(All) | US-Remote
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. 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 PRA employees and contractors within the designated therapeutic or functional areas.
Bachelor’s degree in science, health profession, or journalism.
At least 5-7 years experience writing for pharma or biotechnology.
Manager, at least 2 years line management experience.
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).
Ability to understand Sponsor guidelines and requirements related to the preparation and pr…
Editing , Medical & Health , Project Management , Writing