Vera Therapeutics, Inc.

• Facilitate scientific training for the field medical team focused on disease state • Assist medical information in preparing the team for scientific milestones • Initiate scientific practice sessions including mock dialogues • Support scientific-readiness learning following major publications • Lead new-hire scientific onboarding with targeted scientific exercises • Partner with field medical leadership to provide individualized coaching • Strengthen team capability in identifying, interpreting, and communicating competitive intelligence • Communicate observed CI trends and insight themes to medical leadership • Maintain an assigned geographic territory and execute all core responsibilities of an FMD • Engage with KEEs through meetings as well as at congresses and advisory boards • Deliver proactive disease state education and discussions regarding product data • Partner with Medical Communications, Publications, Clinical Development, HEOR, and Compliance • Participate in special projects as necessary • Travel required (up to 50%)

• Engage with Key External Experts through meetings (both face-to-face and virtual) as well as at congresses and advisory boards. • Expected to deliver proactive disease state education, and reactive discussions regarding product and clinical trial data. • Provide appropriate scientific, clinical, and educational support to internal and external customers. • Build a territory plan and establish key relationships with external communities, including professional societies. • Support cross-functional medical pre-launch processes to ensure launch readiness and medical excellence. • Take an active role in the planning and execution of educational activities at key scientific congresses and help develop the medical affairs congress strategy at both the national and regional levels, in collaboration with the medical affairs team. • Lead and/or participate in special projects as necessary. • Travel required (up to 50%).

• Own and manage the lifecycle of reference standards and critical reagents, including primary, working, interim, in-house, compendial, and assay control/standards from receipt and qualification through issuance, requalification, and retirement. • Review and assess analytical data associated with reference standard qualification, stability monitoring, trending, and assay performance. • Author, review, and approve GMP documentation including SOPs, qualification/requalification protocols and reports, CoAs/CoCs, deviations, CAPAs, change controls, and technical reports. • Establish and maintain strategies for qualification, characterization, bridging, and requalification of reference standards and critical reagents to support analytical testing and product release. • Ensure uninterrupted supply, inventory control, storage, labeling, distribution, and tracking of qualified reference standards and critical reagents for GMP operations. • Define and oversee appropriate storage, handling, shipping, and environmental monitoring requirements, including management of temperature excursions and investigations. • Collaborate with Analytical Development, QC, and external laboratories to support method qualification, validation, comparability assessments, and commercial specification setting activities. • Maintain accurate and inspection-ready records within electronic systems. • Support investigations related to deviations, OOS/OOT results, atypical trends, and risk assessments associated with reference standards and critical reagents. • Partner with Regulatory Affairs to support regulatory filings, responses to health authority questions, and preparation of analytical sections related to reference standards and assay controls. • Support internal audits, external inspections, and health authority inspections by ensuring inspection readiness of documentation and systems. • Manage activities at CDMOs and contract testing laboratories related to reference standard qualification, inventory management, and analytical support. • Drive continuous improvement initiatives to enhance operational efficiency, compliance, scalability, and business continuity for reference standard and reagent management processes.

• Lead global clinical safety, pharmacovigilance and risk management activities throughout the product lifecycle for investigational and marketed products across the pipeline • Build and manage a high-performing, inspection-ready pharmacovigilance team by setting clear expectations & providing hands-on leadership, promoting operational excellence, collaboration and team cohesiveness • Provide strategic oversight for safety sections of all regulatory documents, including BLA/MAA/NDA, public presentations and key scientific articles and abstracts • Ensure robust processes are in place for case processing, aggregate reporting, signal detection, benefit–risk assessment, and risk management • Advise Leadership on safety matters and provide strategies for addressing benefit-risk and risk management, including communication to patients, health care providers, and regulatory authorities • Partner with Regulatory Affairs, Clinical Development, and Quality Assurance to ensure full compliance with GVP, GCP, and corporate quality standards • Provide medical guidance and evaluation of all pre- and post-marketing safety data • Collaborate cross-functionally and with key internal and external stakeholders, including Clinical Operations, Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Senior management, regulatory agencies, alliance partners, investigators and key external experts

• Leads the manufacturing and supply chain teams, providing leadership aligned with Vera values resulting in a high performing organization. • Contributes to the strategic leadership of Vera’s late-stage programs acting as a strong team player. • Participate in sales and operations planning (S&OP) and Product Development Teams representing the Product Development and Manufacturing function. • Create synergy and knowledge sharing to enable optimal production planning processes to balance supply/demand risks. • Serves as a single point of contact to manage end-to-end global supply chain and foster the needed supplier relationships to drive excellence using appropriate metrics. • Serves as a strategic thought leader to craft and manage commercial supply contracts with an eye towards life cycle extension programs. • Create, develop and manage necessary tools for end-to-end demand/supply planning. • Provide strategic direction, technical guidance, and long-range planning for late-stage programs: BLA-enabling studies through BLA submission, commercial launch, and sustaining operations. • Develop and manage department budgets and ensure fiscal responsibility for manufacturing operations. • Develop fit for purpose operational processes and systems to support supplier metrics and other tools to enable continuous improvement / process excellence.

• Serve as the System Owner and hands-on administrator for GxP systems (e.g., TraceLink, Lorenz DocuBridge, Egnyte Life Sciences, ZenQMS, Global Vision, Veeva), overseeing system lifecycle, performance, and compliance • Participate in system implementation activities, including vendor selection, requirements gathering, testing, and deployment to ensure alignment with business and regulatory needs • Provide oversight and direction for Computer System Validation (CSV) activities and validation documentation, partnering with the Validation Engineer to ensure regulatory compliance and audit readiness • Own and lead Change Control processes for all GxP systems, including impact assessments, risk evaluations, documentation, coordination of testing, and release management • Perform system administration activities, including user access provisioning, role management, periodic access reviews, and audit trail monitoring • Oversee system maintenance, enhancements, and issue resolution (e.g., upgrades, patches, changes), ensuring appropriate validation impact assessments, documentation updates, and minimal business disruption • Collaborate with IT and vendors to support integration, system performance optimization, and resolution of technical issues • Develop and maintain system-related documentation, including SOPs, Systems Inventory, administrative procedures, and work instructions in collaboration with Quality Assurance and business stakeholders • Provide SME support during FDA audits and inspections, including preparation, documentation review, and representation of system controls and validation status • Drive continuous improvement by identifying gaps, inefficiencies, and opportunities for system scalability and automation • Translate business requirements into effective system solutions, acting as a key liaison between business stakeholders and technical teams • Manage project timelines, risks, and deliverables to ensure successful and compliant execution of system initiatives

• Oversee and work directly with CROs to provide guidance, effectively monitor and QC their deliveries for quality, time and budget adherence. • Follow CDISC SDTM and ADaM standards and guidelines; validate SDTM, ADaM datasets and TFLs generated by the CRO. • Work with the internal teams and CRO to prepare submission-readiness datasets (e.g. SDTMs, ADaMs) and metadata to support the BLA filing. • Hands-on statistical programming to support CSR, publications, presentations, DSUR, IB update, safety data review, RTQ, and ad hoc analyses. • Attend SMT and collaborate with the study statistician and other study team members in project planning and timeline discussions. • Review key study documents including but not limited to study protocol, SAP, and CDM documents like CRF and DTA and provide inputs to represent statistical programming function. • Work collaboratively with stakeholders and other developmental functions to standardize, maintain, and implement the data transformation and statistical analysis requirements. • Ensure that all programming and data are conducted in compliance with GCP, relevant SOPs, and regulatory requirements; review and file study documentation in the trial master file (TMF) system acceptable for audit. • Familiar with SAS server working environment and adherent to server and programming SOP. • Proficiency in R for statistical analysis, data analysis, modeling, and data visualization

• Responsible for quality oversight of biologics sterile drug product (DP) manufacturing and combination products, including design control and Design History File (DHF) requirements. • Responsible for implementing strategies and tactics to promote and maintain GxP compliance. • Lead quality aspects of and provide quality support on DP tech transfers. • Liaise with CMO Quality partners to communicate QA policy and procedures. • Collaborate with contract manufacturers and internal stakeholders to address deviations/ investigations and compliance issues. • Responsible for material disposition of commercial and clinical DP/ combination products. • Review executed batch records and associated documentation for material disposition. • Review and approve GMP documentation such as master batch records, deviations, change controls, specifications, and various other protocol and reports to support GMP production. • Review and approve validation protocols and reports such as process validation, shipping validation, cleaning validation, etc. • Provides assistance during both internal and regulatory agency audits as required • Perform Person-in-Plant duties, as required. • Participate in Material Review Board as required. • Helps define and implement appropriate quality standards/specification, methods, systems, and metrics for clinical and commercial quality operations. • Act as the Quality representative on assigned product teams to advocate compliance and quality assurance. • Lead for Quality Agreement with external partners. • Support product lifecycle and continued process verification. • Availability for 10-20% travel, both domestically and internationally.

• Provide oversight of Trial Master File management across clinical development programs and functions. • Partner closely with Clinical Operations, Clinical Supply Chain, Data Management, Pharmacovigilance, Regulatory Affairs, and other development functions to ensure essential clinical documentation is appropriately maintained within the TMF. • Facilitate periodic TMF health discussions and ensure alignment on TMF quality and completeness expectations. • Interface with CROs and external vendors responsible for TMF activities and contributes to maintaining TMF inspection readiness across the organization. • Support TMF lifecycle activities including study start-up planning, ongoing TMF maintenance, study closeout, and TMF archival in accordance with regulatory and company retention requirements. • Establish and maintain consistent TMF management practices across studies and programs. • Conduct routine TMF health reviews and collaborate with study teams and document content owners to identify documentation gaps and ensure appropriate remediation. • Oversee quality, completeness, and timeliness of Trial Master File (TMF/eTMF) documentation across clinical studies. • Develop and track eTMF metrics for studies and communicate trends or issues identified to study teams and management. • Serve as the eTMF system administrator, supporting user access management, system configuration support, troubleshooting, and ongoing optimization of system functionality. • Support regulatory inspections and internal audits involving TMF records and management. • Collaborate with the Head of Clinical Quality Assurance and system users to identify opportunities to improve TMF processes, system functionality, and inspection readiness practices. • Work with the eTMF system owner and IT or system support teams to implement system improvements in accordance with required change control and validation procedures.

• Manage day-to-day T&E operations, ensuring timely processing, auditing, and reimbursement of employee expense reports. • Develop and operate systems to monitor T&E reporting for compliance with company policies, including healthcare compliance. • Oversee compliance with the Sunshine Act and related state transparency reporting, including accurate capture, categorization, and reporting of payments and transfers of value to healthcare professionals. • Partner with Compliance and Sales Operations teams to ensure data integrity and resolve discrepancies. • Maintain and update T&E policies, ensuring they align with internal best practices. • Train employees on expense reporting tools, policies, and compliance requirements as needed. • Prepare and submit monthly Sunshine Act transparency reports to IQVIA, ensuring accuracy and timeliness. • Identify process improvements to streamline expense reporting and compliance workflows.