As a Manager Medical Writing you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

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 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 employees and contractors within the designated therapeutic or functional areas

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