Asklepios BioPharmaceutical, Inc. (AskBio)

Operations

• Lead the development and implementation of strategic planning tools and frameworks for medical planning preparations execution and accelerated readiness through process and system optimization.
• Lead MRB process and implementation of Veeva platform to support the review of submitted materials to ensure compliance standards based on AskBio SOPs.
• Lead the implementation of Veeva platform for MRB working in close collaboration with regulatory and medical affairs team members.
• Lead publication process and implementation of review portal working closely with publication managers.
• Provide training and ensure compliance is met based on the publication policy and SOP set by AskBio standards.
• Define business requirements for Medical Operations, Field, and medical systems and corresponding SOPs. Lead the evolution of these systems to meet business needs and compliance standards.
• Design and deliver an enhanced Medical Insight Generation process.
• Work closely with Therapeutic area leads and external affairs to plan the congresses to support the scientific messages and external engagement.
• Lead the development and implementation of Medical Affairs Therapeutic Team strategic asset plans.

AD Medical Affairs Operations – Capabilities

Supply Chain

• Plan and coordinate GDP/GMP-compliant logistics for critical materials (e.g., cell banks, samples, products, components) being stored and/or shipped by third party vendors (e.g., couriers, depots)
• Ensure all shipments are prepared, processed, and transported in accordance with regulatory requirements and AskBio’s SOP’s, processes, and instructions
• Manage and track AskBio’s inventory at third party vendors/depots and external manufacturing partners (i.e., CDMOs)
• Conduct inventory reconciliations (e.g., cycle counts, aging reviews) and initiate corrective updates to maintain data integrity
• Maintain accurate documentation and records for inventory, shipments, and storage for critical materials (internal and external systems)
• Assist with supply planning and logistics workstreams; contribute to operational excellence, problem-solving, and continuous-improvement activities
• Participate in budgeting and forecasting efforts within the GMP Supply teams
• Build effective working relationships with Manufacturing, Program Management, and Clinical Supply leads to keep material readiness aligned with program plans
• Support deviations/change controls/CAPAs tied to logistics or inventory workflows by providing data, timelines, and document links
• Support audits and investigations by preparing documentation/data and responding to supply chain-related queries

AD Medical Affairs Operations – Capabilities

Supply Chain Specialist