• Creates and manages the Dossier Plan(s)/Submission Packages in line with regulatory strategy. Ensures that all required documents are included in the Dossier/Submission Package. • Performs a dossier review of the published output. • Track's submission events/activities and timelines in appropriate systems/tools.• Leads submission team meetings. Provides guidance to project team members. Seeks input from regulatory therapeutic areas, functional area representatives and key stakeholders. Works with team to resolve issues with timelines. • Monitors the effectiveness of the dossier process to identify improvement opportunities.• Leads and/or participates in special projects and process improvement initiatives, as needed.• Where appropriate provides component-level publishing support for Regulatory-owned deliverables in PDF format to ensure dossier components conform to submission standards (e.g., bookmarking, linking, PDF version, etc.).• Utilizes current electronic document management systems/tools and/or publishing technologies to assemble and publish dossiers according to regulatory requirements for paper and electronic submissions.• Applies appropriate regulatory submission standards, requirements, processes, and policies to comply with applicable health agency requirements.• Cultivates ongoing effective relationships within GRA as well as cross-functionally. Works with partners to communicate and resolve issues/concerns with submission timelines.

• Manage the overall compilation and submission of complex health authoritysubmissions for assigned projects • Responsible for submission compilation: assigning metadata, locations within the eCTD modularstructure, building XML backbone, eCTD leaf titles, and lifecycle operators • Responsible for ensuring product labeling is drug listed• Proofread, submit and track product labeling and coordinate the internal distribution process forassigned projects• Responsible for the management of NDA Annual Reports as well as regional specific appendices to PBRERs, PADERs, and IND DSURs• Provide quality control of eCTD submissions prepared by other DRA Operations staff• Responsible for daily prioritization for assigned projects and escalating issues to DRA OperationsGroup Leader and for communicating project related activities to other assigned DRA operationscolleagues• Mentor and support local DRA support staff as needed to ensure business continuity• Adhere to the US DRA records management system• Provide support to DRA Project Leader/Manager(s) and serve as liaison between documentation groupacross sites in meeting project deliverables for assigned projects• Represent DRA on Clinical Trial Teams and interface between Clinical Trial Teams, DRA ProjectLeader, Science, Global Quality Management or other departments, as required, to provide regulatoryoperational input• Understand and communicate health authority procedural guidelines, decisions and actions, in relationto projects• Create & maintain protocol records on Clinicaltrials.gov• Author, review and maintain DRA-Ops SOPs, policies, templates and guidelines• Participate in the creation, development and implementation of the U.S. labeling documentationprocess, procedures and templates• Mentor and guide other Operations staff in preparing, submitting, tracking and communications relatedto product labeling• Provide support for annual electronic drug listing and registration

• Ensure that North American timelines are met while keeping open communication within study team• Develop & update project metrics tracking spreadsheets• Review & approval of Institution ICF to ensure that it meets regulatory requirements, protocol requirements and follows all applicable internal SOPs• Review & provide comments for initial Investigator budget template to ensure that all protocol procedures are captured correctly• Review, negotiation & approval of Institutions study budgets• Review & provide comments on documents/forms that are necessary for the conduct of the study (Monitoring Guidelines, Site Guidelines, Delegation of Authority, Core ICF, Study Drug Logs etc.)• Review & provide comments on outside vendors manuals & forms that are necessary for the conduct of the study• Prepared, collected and reviewed necessary Regulatory documents while aiding site personnel with the retrieval of missing documents and the revision of incorrect documents (Form FDA 1572, CV, Medical & Laboratory Licenses etc.)• Ensured compliance with Regulatory Affairs’ requirements for initial drug shipment and study maintenance throughout the clinical trial• Maintained regulatory document tracking spreadsheet to track status of study start up activities• Assist clinical team in the coordination of Investigator, Study Coordinator, & Monitor Meetings• Provide support to Regional Monitors• Mentor, train, & provide guidance to Clinical Research Associates• Maintain tracking & distribution of clinical trial supplies

• Internal backup contact for Clinical Trial Managers; knowledge of nine (9) oncology protocols• Coordinate the identifying and recruiting of Investigator Sites during the study start up phase• Assist Investigator Sites with their submissions to IRB/REB and Institution Scientific Committees. This includes preparation and/or review of documents such as ICF and IRB/REB applications.• Prepare Local IRB/REB paperwork for submission and also manage this relationship throughout the clinical trial• Prepare, collect and review necessary Regulatory documents while aiding site personnel with the retrieval of missing documents and the revision of incorrect documents (Form FDA 1572, CV, Medical & Laboratory Licenses, etc.)• Ensure compliance with Regulatory Affairs’ requirements for initial drug shipment and study maintenance throughout the clinical trial• Assist with the review of designed project Case Report Forms prior to final approval • Assist with the review, negotiation, and approval of Investigator Contracts & Budgets• Trigger and track initial & quarterly investigator payments while ensuring that they are made in accordance with the Investigator Contract & Budget• Create IND Safety letters that accompany drug-related Serious Adverse Event Reports, which are sent to Investigator Sites• Create & maintain protocol records on Clinicaltrials.gov• Created and implemented the use of Clinical Tracking Spreadsheets to ensure that studies were tracked properly and in a standardized manner (Patient Enrollment, Legal Documents, Vendor Payments, Investigator Payments, Regulatory Documents, etc.)• Trained new employees (Clinical Trial Assistant)• Attend pre-study, initiation, and interim monitoring visits for training purposes• Draft pre-study and initiation monitoring reports

• Prepared, collected and reviewed necessary Regulatory documents while aiding site personnel with the retrieval of missing documents and the revision of incorrect documents (Form FDA 1572, CV, Medical & Laboratory Licenses etc.)• Ensured compliance with Regulatory Affairs’ requirements for initial study drug shipment and study maintenance throughout the clinical trial• Maintained regulatory document tracking spreadsheet• Determined IRB documentation requirements and assisted Investigator Sites with their submission to IRB/REB• Received and processed study supply requests ensuring that orders were sent to Investigator Sites in a timely manner (Study drug, Clinical Laboratory test kits and CRFs/Patient Diaries, etc.)• Processed and tracked Serious Adverse Event reports and followed-up with Investigator Sites for collection of safety-related data• Tracked patient enrollment and progress and followed- up with Investigator Sites to ensure that enrollment logs were received in a timely manner• Created and maintained project and investigator files• Participated in project team meetings and teleconferences• Worked closely with Regional CRAs to resolve issues that occurred at Investigator Sites • Ensured that Regional CRAs were supplied with necessary study material• Worked with Finance to ensure that Investigator payments were completed and sent to the site