Head of Global Regulatory Writing - Basking Ridge, United States - Daiichi Sankyo

Description

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Summary

This role is responsible for leading the Regulatory Writing function, overseeing, directing and being accountable for all regulatory/medical writing strategy and activities for Daiichi Sankyo's portfolio, across all markets. This role is responsible for establishing an adaptable, scalable and sustainable structure for Regulatory Writing, positioning it as a strategic partner for key stakeholders including Clinical Development and Regulatory Strategy teams, to create scientific documents supporting Daiichi Sankyo's product development and submissions to Health Authorities. This position is the single-point of accountability to set global standards for regulatory/medical writing related activities, processes, innovations and improvements, and drive the implementation of such standards to maximize global efficiency and strategic alignment of Daiichi Sankyo scientific documents sent to Health Authorities. The individual in this role is accountable for the function meeting Health Authority standards while delivering reviewer-friendly documents that communicate our position based on scientific evidence. This will include resolving conflicts, managing and influencing global stakeholders across all levels, and building relationships to ensure the success of the function. This role will plan and assesses both internal and external resource management and allocation, and directly oversee >40 regulatory writers and contractors located across the USA, EU, Japan and China. The individual in this role must have expertise and scientific knowledge in oncology and at least one other therapeutic area.

Responsibilities

- Sets the global vision for the Regulatory Writing function, develops the functional strategy across all business portfolios and provides overall leadership to the function. Investigates and implements Regulatory Writing innovations and establishes the use of global regulatory/medical writing standards at Daiichi Sankyo. Collaborates and manages stakeholders (globally and regionally) to ensure success of strategy, vision, and mission of the Regulatory Writing function. Serves as the global head of Regulatory Writing and represents Regulatory Writing both globally and regionally at Daiichi Sankyo. Closely collaborates with Regulatory Operations to partner on key deliverables (CSRs, submission documents, etc.) and timelines, as well as process optimization activities that pertain to critical submission deliverables.
- Establishes and mentors dossier leads, aligned with portfolio priorities, who establish the product's regulatory/medical writing strategy for global and regional submission summary modules and leads the strategic development of submissions (e.g., NDAs, SNDAs, BLAs) and related timelines. Leads a group of 40+ writers (FTE and contract) across the USA, EU, Japan and China. Prioritizes opportunities for attracting, training, building capabilities and enabling career progression for regulatory writers.
- Accountable for work delegated to CROs. Sets the outsourcing strategy for Regulatory Writing and partners with Procurement to recommend and select CROs. Makes the final recommendation for CROs for Regulatory Writing and monitors performance of CRO organizations and external Regulatory Writers involved in DS Regulatory Writing work.
- Provides global strategic support and leadership to other functions such as Clinical, QCP, BDM, Regulatory Affairs and Medical Affairs in all aspects of regulatory/medical writing and fosters the visibility of Regulatory Writing across all functions of RD globally, as well as global Medical Affairs, as applicable.
- Sets global standards for regulatory/medical writing-related activities, processes, metrics, innovations, and improvement dimensions. Sets and drives implementation of these standards. Explore opportunities to leverage emerging digital tools and technologies to support and enhance writing activities, to drive continuous improvement in efficiency and effectiveness. Provides necessary guidance and training to other functions related to Regulatory Writing.
- Resolves complex, cross-functional conflicts across the organization as pertinent to the Regulatory Writing function
- Plans and assesses resources and resource needs across all therapeutic areas and geographical regions, based on current and future workload and project priorities, based on Daiichi Sankyo's product portfolio and pipeline. Responsible for efficient and responsible use of resources. Foresees future business needs and plans for changes. Foresees training and development needs. Establishes and maintains the Regulatory Writing resourcing plan and budget in accordance to portfolio and business needs
- Manages and mentors dossier leads and regional Regulatory Writing hub leads who are direct reports, and provides guidance on mentoring and supporting their direct reports and colleagues to develop professionally at Daiichi Sankyo in order to benefit the business, enhance retention, and achieve consistency across all regions and teams

Qualifications:

Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education Qualifications (from an accredited college or university)

- Master's Degree Degree in a scientific discipline required
- MD Degree in a scientific discipline preferred
- PhD Degree in a scientific discipline preferred

Experience Qualifications

- 10 or More Years Experience leading submissions required
- 10 or More Years Previous experience leading and managing a medical/regulatory writing group required
- 10 or More Years People management & leadership experience required

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.