Within a designated therapeutic or functional area leads a single team which formulates the writing strategy for key response documents and regulatory submissions guides medical writing document preparation, including coordination of assignments to contract 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 US and international regulatory guidance and requirements for content and format, requirements (style, electronic integrity, and process), and project- or therapeutic area-specific guidance related to content and organization of specific documents. Leverages internal and external resources to achieve quality, timely and cost-effective compound level submission deliverables. Participates in the training, guidance, and mentoring of the medical writing junior staff and may oversee junior staffs’ deliverables.
EDUCATION, EXPERIENCE AND SKILLS:
Knowledge and Skills:
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
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