Shionogi Inc. (U.S.)

Compliance

• Serve as an advisor and primary point of contact between Compliance and field-based personnel in Commercial functions (Sales, Managed Markets) and Medical functions (MSLs).
• Work with cross-functional teams to provide guidance to field personnel and managers regarding identification and mitigation of potential compliance risks as they relate to field activities and initiatives.
• Assist in periodic review of, and updates to, Compliance policies, SOPs, guidance, and the Code of Conduct, as required.
• Support development of new/updated field training assets on compliance-related topics.
• Collaborate with colleagues in other support functions (including Operations, Training, and IT) to ensure compliant and timely roll-out of training programs and other initiatives.
• Assist field personnel and managers in issue review/resolution and escalate matters to VP Compliance or other Compliance team members, as appropriate.
• Support gathering of information for field-related inquiries and investigations, as needed.
• Engage in live and virtual monitoring of field-driven activities and data, including but not limited to ride-alongs, speaker programs, field communications, field-generated data, and Medical Information Requests (MIRs).
• Represent Compliance during product launch activities and/or integration of new products.
• Support the Aggregate Spend Specialist in the review of field-generated transfers of value (TOVs).
• Support the VP Compliance in additional activities, as requested, such as the company’s Annual Global Compliance Week and other special projects.
• Support the development and customization of field training materials, including slide decks, e-learning modules, handouts, and job aids tailored to role-specific risks and considerations.
• Track and monitor training completion using learning management system or manual trackers, as applicable, and follow up with field personnel for whom training is nearing the due date or overdue.
• Collect and summarize post-training feedback to identify potential opportunities for improvement.
• Other duties as assigned.

Compliance Field Liaison

Director

• Lead the cross-functional planning and coordination of all aspects of launch including HCP and Consumer marketing
• Work closely with internal leads in each functional area to gain alignment
• Direct the design and execution of the commercial strategy and tactical planning
• Oversee all key aspects of market understanding and promotion
• Collaborate closely with Medical Affairs in designing and executing communications activities
• Establish credibility and build mutually respectful relationships with senior leadership in the US
• Create, track and present launch readiness activities and key performance indicators

Executive Director, Brand Lead

Manager

• Manage activities of CROs, vendors, and temporary staff performing PV operations.
• Oversee and guide case processing activities to ensure effective monitoring and evaluation of product safety information.
• Oversee PV system to ensure compliance of employees, partners and distributors.
• Maintain safety databases (e.g., Argus, ArisG) and ensure data accuracy and compliance.
• Ensure ongoing maintenance and revision of PSPV Standard Operating Procedures, Work Instructions, and Job Aids.
• Ensure PV operation continuity including maintenance of process or disaster recovery plan of Safety Database.
• Supervise and manage preparation and submission of aggregate reporting in accordance with applicable regulations.
• Maintain training matrix in PSPV team and lead trainings of PSPV members or new hires.
• Oversee preparation and execution of deviation reports, note to files and Corrective and Preventive Actions (CAPAs).
• Manage pharmacovigilance agreements or safety clause in contracts with partners or CROs.
• Act as the responsible contact person for safety-related aspects and PV.

Product Safety & Pharmacovigilance Manager

QA Engineer

• Analyze and oversee quality assurance of pharmaceutical product
• Identify, mitigate, and resolve regulatory compliance and quality issues that may affect drug products
• Perform batch records review and communicate any adverse findings to approved Contract Manufacturing Organizations (CMO)
• Perform product quality investigations and participate in the assessment of each investigation
• Review investigation reports and complete the timely closure of all batch record review findings prior to product release
• Resolve quality issues, and product complaints including investigations, deviations, OOS/OOT investigations, CAPAs, change controls, and quality complains related to manufacturing packaging
• Implement CAPAs and assess CAPA effectiveness
• Review and approve stability protocols and stability results
• Review and Approve Validation (process, cleaning, method) protocols and reports
• Author and review Annual Product Review
• Draft and negotiate Quality and Technical Agreements
• Provide support during regulatory inspections and audits, including Labeling development
• Implement and maintain quality systems, including change control, vendor qualification programs, internal and external audits, SOPs, and process improvement.

Quality Assurance Manager

• Provide quality oversight and GCP guidance to clinical study teams and vendors
• Ensure compliance with ICH GCP and FDA regulatory requirements
• Evaluate clinical trial documentation and processes
• Conduct regular vendor audits or assessments

Senior Manager, GCP QA

• Support document formatting and QC in alignment with Shionogi standards for submission-related materials.
• Assist in the remediation and QC of PDF documents, including bookmarking and hyperlinking to ensure regulatory-compliant electronic files.
• Assist in ensuring all communications with health authorities are properly archived within the company’s system and adhere to applicable regulatory guidelines.
• Assist the archiving and retrieval of documents from offsite storage facilities.
• Provide ongoing support to the Regulatory Operations team.

Regulatory Operations Documentation Specialist

• Provide temporary QA support to maintain quality and compliance oversight of sterile pharmaceutical products manufactured by third-party partners.
• Review manufacturing and packaging batch records; escalate issues and perform final disposition of assigned products.
• Support and coordinate investigations (deviations, OOS/OOT, product complaints), initiate CAPAs, and ensure timely closure.
• Maintain ongoing communication with contract manufacturers to resolve quality issues, monitor compliance, and ensure product release readiness.
• Provide QA input during regulatory inspections and support documentation needs (change controls, stability protocols, technical agreements).
• Assist in ensuring that audit findings are tracked and CAPAs are effectively implemented.
• Collaborate with Supply Chain, Regulatory, and other partners to ensure continued product quality and supply continuity.
• Lead large-scale technology transfers.
• Build or negotiate new or existing quality agreements
• Provide support for Shionogi Developmental Products as needed