Shionogi Inc. (U.S.)

Director

• Identify areas of high unmet need working with GEE and GMA as well as other cross-functional colleagues as needed
• Define evidence generation requirements to quantify unmet need, how asset’s projected efficacy is to positively effect patient and health system outcomes
• Conduct payer research to inform pricing and evidence requirements to address areas of high unmet need
• Provide guidance to cross-functional colleagues, including new product planning, to maximize value of a given asset (indication prioritization)
• Engage external experts (former or current payers and HTA assessors, clinical thought leaders) to better understand stakeholder perspective around unmet need and how to effectively optimize the asset’s value proposition
• Draft asset’s value proposition; inform the asset’s target product profile; work with cross-functional colleagues as needed to inform the asset’s development programs across stage gates (including Ph 1, Ph 2 and Ph 3)
• Seek input from regulators through EMA|HTA joint scientific advice to inform an asset’s development program
• Engage with regional and affiliate market access colleagues, and other cross-functional colleagues as needed to develop global market access-related deliverables such as the global value dossier and relevant economic models
• Establish global pricing and policy strategy
• Inform asset launch sequence and early market access programs
• Act as subject matter expertise on market access trends in major markets that impact on pricing potential and reimbursement for a given asset in development
• Ensure value optimization is maintained post asset launch by working across regions to identify additional evidence generation required to bolster the asset’s global value proposition
• Conduct and or support special projects as needed to stay current on global market access trends and implications to Shionogi portfolio

Director/Senior Director, Global Healthcare Value & Access

Account Manager

• Establish clinical understanding and demand within ID physician, pharmacist and microbiology community
• Promote product to targeted accounts
• Create opportunities for product education
• Collaborate with various stakeholders for formulary adoption

Key Account Manager

Compliance

• Assist in performing document formatting per Shionogi standards for submission related documentation.
• Assist in the remediation of PDF documents by bookmarking, hyperlinking and QCing to ensure compliant electronic files.
• Provide support to the Regulatory Operations team.
• Provide general assistance to the Regulatory Affairs department as needed.

Regulatory Operations Documentation Specialist – Contractor

• Lead the Regulatory Operations - Documentation Specialist team in overseeing the documentation processes within an organization, ensuring that all documents are accurate, compliant, and efficiently managed.
• Involve in improving documentation workflows, and ensuring regulatory compliance.
• Include document formatting, remediation and quality control (QC) of documentation for submissions to Health Authorities.
• Archive correspondences to and from the health authorities and internal and external GRM archiving.
• Provide direction and support to the documentation team, ensuring high-quality work and adherence to standards.
• Train team on documentation standards, procedures, and tools to ensure consistency and compliance.
• Ensure all documents meet the organization's quality standards and regulatory requirements.
• Continuously enhance documentation processes to improve efficiency and productivity.
• Maintain document control processes for proper classification, indexing, distribution, and archiving.
• Work closely with other departments to gather information and ensure comprehensive documentation.
• Manage and support team members that ensure all correspondences to and from the health authorities are archived within the company’s system and comply with regulatory standards and guidelines.

Director/Senior Director, Global Healthcare Value & Access

Key Account Manager

Regulatory Operations Documentation Specialist – Contractor

Regulatory Operations Documentation Specialist, Manager