Ora

• Responsible for researching, writing, and editing materials for regulatory submission to the FDA from pre-clinical to clinical trials Phase 1 - 4 • Works collaboratively with Clinical Project Managers, Clinical Trial Associates (CTA) and other cross-functional departments • Identifies and executes timeline plans for clinical, nonclinical, and CMC • Coordinates, authors, and develops drug applications and submissions in support of clinical programs • Offers high visibility and exposure to FDA regulatory requirements, Good Clinical Practice (GCP), ICH guidelines, and/or eCTD format • Author and compile FDA and Ex-US regulatory applications and submissions • Assist in the research of scientific and regulatory information to write submission documents • Work with data management and clinical teams to review protocol development and interpret clinical trial data • Responsible for contributing to project timelines and regulatory milestones • Responsible for communication of commitments to team members • Lead multiple, concurrent projects, with support from the Principal or Regulatory Manager • Format and edit regulatory documentation for inclusion in INDs, CTAs, and other global submissions • Support on-time preparation and publication of regulatory submission documents

• This role is responsible for the accurate, and timely, recording of financial data in accordance with all regulatory requirements. • As the owner of the financial books and records, the successful candidate will direct the preparation of the month-end and year-end close, consolidations, the preparation of internal and external financial reporting, and provide any/all information required for tax reporting/submission. • In addition, the role is responsible for performing research on technical accounting issues, developing and implementing financial policies and procedures across the organization, and coordinating the review/audit of Ora’s and its subsidiaries as required by all national and local authorities. • Direct the preparation of financial statements in accordance with US GAAP and/or IFRS requirements for non-US entities where needed for Ora Inc. as well as all of its subsidiaries. • Manage all associated finance functions supporting the accounting including General Ledger, Accounts Receivables, Accounts Payable, Payroll, and Treasury. • Ensure a properly operating set of systems, processes, and procedures to properly capture, track and report financial results, in accordance local accounting requirements and company policies. • Manage/direct the relationship with non-US financial and tax reporting entities that support Ora Inc. (eg. Findex – Australia; RSM – China; Oury Clark – UK; TMF Group - Japan). • Ensure a system of internal controls is in place, and operating, to ensure financial stewardship of the company. • Adhere to all aspects of Ora’s quality system. • Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora’s data integrity & business ethics and regulatory requirements. • Clear and sustained demonstration of Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors.

• Responsible for assisting the Regulatory submissions team in QC, coordination of document preparation, management, and submissions within (and around) Europe. • Performs the role of a Regulatory Lead for studies primarily within the European region during study start-up until study close out. • Oversees and performs quality control checks on clinical and regulatory documents, including Patient Information Sheet (PIS)/Informed Consent Form (ICF). • Responsible for and contributes to preparation and submission of documents to regulatory authorities and ethics committees, primarily within the Clinical Trial Information System (CTIS) and other submissions portal(s), as required. • Performs quality control checks on study documents that are received from the sponsor and/or prepared by country CRAs to ensure all submission documents meet Ora's submission standards. • Oversees, coordinates and contributes to development of country adapted study documents and ensuring documents are sponsor approved prior to finalisation. • Contributes to the review and revision of standard operating procedures (SOPs), templates, and forms. • Performs data entry for tracking of regulatory submission activities. • Updates tracking logs, databases, and ensure filing of country adapted and sponsor approved study documents are filed in collaborative workspace. • Prepares the clinical trial application within CTIS with supervision; in compliance with forecasted timelines. • Escalates potential issues identified to impact forecasted timelines quickly. • May be required to provide regulatory support in other regions. • Keep up to date with current regulations, guidelines and changes in the industry. • Collaboration with Global Regulatory team and wider stakeholders. • Adhere to all aspects of Ora’s quality system. • Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora’s data integrity & business ethics and regulatory requirements.

• Implement and administer Ora document management systems (Veeva Vault) and related procedures that allow Ora staff to capture, store, retrieve, share, and destroy electronic records and documents in a manner consistent and in accordance with SOPs, ICH GCP guidelines, FDA, and EU Directive (and other global regulatory agencies as needed). • Manage documentation to ensure organization and accuracy. • Ensures clinical records are filed in a timely manner. • Perform quality-control (QC) review of clinical and regulatory documents submitted for entry into the eTMF and liaise with project teams towards documentation issue resolution. • Assist with the development of work processes and systems to support document management, including contributing to SOPs and internal department guidance. Supports initiatives to enhance efficiencies in document management practices. Propose recommendations for improving content management system capabilities. • Train towards and actively serve as a Veeva Vault Super-user who: Provides support and training to team members on processes and eTMF/CTMS software. Supports staff towards resolution of ad hoc system issues. Drives the resolution of identified documentation issues. • Develop and present training materials to educate trial team staff and CDMS I’s on the usage of Veeva, Good Documentation Practices, Ora processes and regulatory guidelines. • Assist the clinical team in the close-out and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. • Process and fulfill document requests from internal and external stakeholders for studies which have been archived in the eTMF. • Generate/review metrics reports intended as periodic review of study files for completeness. • Identify and classify documents or other electronic content according to characteristics such as security level, function, and metadata. • Prepare and record changes to eTMF documents and confirm changes with legal and compliance management staff. • Assist in the development of document or content classification taxonomies to facilitate information capture, search, and retrieval. • Assist in the preparation of support documentation and training materials for end users of document management systems. • Supports assigned TMF corrective action plans. • Responsibilities may differ slightly from the above based on specific needs of the business. • Clear and sustained demonstration of the Ora Clinical’s Values of Customer Service, Leadership, Accountability, Results Oriented, Innovation and Teamwork. • Travel Requirements less than 10%. • Adhere to all aspects of Ora’s quality system. • Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora’s data integrity & business ethics and regulatory requirements. • Clear and sustained demonstration of Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors.

• Develop strong site relationships and ensures continuity of site relationships through all phases of the trial. • Performs, with oversight, clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. • Gain in-depth understanding of the study protocol and related procedures. • Coordinate & manage various tasks in collaboration with other internal roles to achieve Site Readiness. • Participate & provide input on site selection and validation activities. • Perform remote and on-site monitoring & oversight activities using various tools to ensure: • Data generated at site are complete, accurate and unbiased • Subjects’ right, safety and well-being are protected. • Conducts site visits including but not limited to evaluation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. • Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out. • Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. • Identify, assess and resolve site performance, quality or compliance problems and escalates as appropriate in collaboration with Clinical Research Lead and CRA line manager. • Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. • Supports audit/inspection activities as needed. • Travel Requirements up to 75%. • Adhere to all aspects of Ora’s quality system. • Clear and sustained demonstration of Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors.

• Develop strong site relationships and ensures continuity of site relationships through all phases of the trial. • Performs, with oversight, clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. • Gain in-depth understanding of the study protocol and related procedures. • Coordinate & manage various tasks in collaboration with other internal roles to achieve Site Readiness. • Participate & provide input on site selection and validation activities. • Perform remote and on-site monitoring & oversight activities using various tools to ensure: • Data generated at site are complete, accurate and unbiased. • Subjects’ right, safety and well-being are protected. • Conducts site visits including but not limited to evaluation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. • Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out. • Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. • Identify, assess and resolve site performance, quality or compliance problems and escalates as appropriate in collaboration with Clinical Research Lead and CRA line manager. • Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. • Supports audit/inspection activities as needed. • Travel Requirements up to 75%. • Adhere to all aspects of Ora’s quality system. • Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora’s data integrity & business ethics and regulatory requirements. • Clear and sustained demonstration of Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors. • Responsibilities may differ from the above based on the specific needs of the business.

• Develop strong site relationships and ensures continuity of site relationships through all phases of the trial. • Performs, with oversight, clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. • Gain in-depth understanding of the study protocol and related procedures. • Coordinate & manage various tasks in collaboration with other internal roles to achieve Site Readiness. • Participate & provide input on site selection and validation activities. • Perform remote and on-site monitoring & oversight activities using various tools to ensure: • Data generated at site are complete, accurate and unbiased. • Subjects’ right, safety and well-being are protected. • Conducts site visits including but not limited to evaluation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. • Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out. • Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. • Identify, assess and resolve site performance, quality or compliance problems and escalates as appropriate in collaboration with Clinical Research Lead and CRA line manager. • Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. • Supports audit/inspection activities as needed. • Travel Requirements up to 75%.

• Develop strong site relationships and ensures continuity of site relationships through all phases of the trial. • Performs, with oversight, clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. • Gain in-depth understanding of the study protocol and related procedures. • Coordinate & manage various tasks in collaboration with other internal roles to achieve Site Readiness. • Participate & provide input on site selection and validation activities. • Perform remote and on-site monitoring & oversight activities using various tools to ensure: • Data generated at site are complete, accurate and unbiased • Subjects’ right, safety and well-being are protected • Conducts site visits including but not limited to evaluation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. • Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out. • Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. • Identify, assess and resolve site performance, quality or compliance problems and escalates as appropriate in collaboration with Clinical Research Lead and CRA line manager. • Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. • Supports audit/inspection activities as needed. • Travel Requirements up to 75%. • Adhere to all aspects of Ora’s quality system. • Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora’s data integrity & business ethics and regulatory requirements. • Clear and sustained demonstration of Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors.

• Ora’s Senior Clinical Project Managers (Sr. CPM) are critical in driving clinical ophthalmic projects forward utilizing best practices in order to ensure budgets, timelines, and clinical trial requirements are being met on behalf of the sponsor. • This role will work independently to manage cross functional project teams as well as overseeing other projects they are not directly managing. • Sr. CPM’s have active involvement in each assigned project in order to meet milestones, resolve issues and/ or conflicts in addition to frequent interactions with the study team including but not limited to clinical trial associates, monitoring, clinical research coordinators, investigators and senior management. • They are responsible for creating project plans and provide weekly budget and progress reviews for each study in addition to preparing high-quality reports.

• May manage department Clinical Project Managers, Assistant Project Managers, Clinical Trial Associates and other supporting staff. • Manages cross functional project teams derived from the groups within clinical development to deliver a high-quality clinical trial(s) in compliance with all regulations and SOPs. • Works with functional areas on initiating, planning, executing, controlling, closing and resourcing clinical trial projects. • Reviews protocol, source documents and CRFs and tracks them to completion. • Responsible for creating and maintaining project timelines for each project and uses these timelines to track and manage a project’s progress. • Responsible for creating Project Plans (Roles and Responsibility Tables and Communication Plans) and weekly project budget and progress reviews for each study. • Reviews study metrics for performance and quality with the team and management. • Prepares high-quality reports (financial, project, etc.) for management on program status and issues. • Ensures review of clinical electronic Trial Master File (eTMF) for completeness. • Manages and coordinates all vendors involved in the clinical trials (e.g. central labs, IVRS, reading centers). • May represent Ora at professional meetings or seminars. • Participates in preparing new study budgets, proposal documents and participating in bid defenses. • Active role in department and company-wide process improvement initiatives. • Travel of up to 15% is required (mainly domestic, overnight). • Adhere to all aspects of Ora’s quality system. • Clear and sustained demonstration of Ora’s values.