Within a designated therapeutic area the Principal Medical Writer Program Lead formulates the writing strategy for key clinical documents and regulatory submissions. Guides medical writing (MW) document preparation, including coordination and oversight of assignments to MW vendor (s). Assumes primary medical writing responsibility for preparation of key regulatory response documents and strategic documents supporting major regulatory submissions. Formulates writing approach, develops timelines, and assesses resource requirements. 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, Takeda requirements (style, electronic integrity, and process), and project- or therapeutic area-specific guidance related to content and organization of specific documents. Leverages external resources to achieve quality, timely and cost-effective compound level submission deliverables..
- Leads a single team which guides medical writing activities within a designated therapeutic area for key response documents and regulatory submissions.
- 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
- Coordinates and provides oversight for the activities of medical writing vendor(s) (, and ensures resolution of issues.
- Within designated therapeutic or compound function, manages deliverables and preparation of documents for submission to FDA or other regulatory agencies, ensuring consistency of content within therapeutic areas and adherence to regulatory requirements and Takeda requirements and processes across development programs.
- Represents Medical Writing on cross-functional teams and task forces (related to projects, process, and standards).
- As required, serves as lead writer for strategic regulatory 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 Program Lead is seen as an expert in medical writing and performs work independently with minimal supervision.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
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 FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs).
- Ability to understand Takeda guidelines and requirements related to the preparation and production of regulatory documents and submissions.
- 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.
- Knowledge of team dynamics and ability to function as a team leader.
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Carrying, handling and reaching for objects.
- Approximately 10% travel is required.
- Ability to drive to or fly to various meetings/client sites limited overnight.
- Some international travel may be required.
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