Annette Rice Email and Phone Number

Working in a contractor capacity, responsible for the collection, organization and management of regulatory data and documentation. Primary responsibilities include performing data entry utilizing Gilead’s proprietary Systems (GRASP, Veeva QMS, Veeva Vault RIM, SAP and GPLM) and maintaining relevant product information to support cross-functional stakeholders. Work collaboratively to support the RA CMC team to meet deliverables and timelines by executing routine data entry, quality control of that data entry and associated reports. Ensure completeness, correctness and consistency of data and data structure. Responsible for supporting project work for enhancements to information systems for RA CMC and stakeholders who utilize RA CMC data. Responsible for development and acquisition of required system skill and knowledge, training supported by manager and peers. Work closely with the senior Regulatory Affairs CMC, Operations and Technical Team.

Manage large document migration of historical content into a newly implemented Veeva Vault Quality Document and Quality Management system. Facilitate pre-launch and implementation activities, identifying appropriate resources and overseeing execution of data migration tasks for CMC and Quality Assurance. Identify source documentation in multiple source systems, evaluate source for migration (Box, SharePoint) and content held by partners. Oversee all analytical, non-commercial manufacturing, R&D and GxP documentation, receiving and maintaining all GxP documents, including test methods, specifications, deviations, CAPAs. Ensure document compliance, aligning appropriate metadata and related records within a validated system.Support Document Control to track GxP training, update training curriculum and assist in periodic audit of records. Support logistics specific to the movement of API/drug substance, non-commercial drug products and material batch releases to CMO. Technical responsibilities include working closely with Quality and Document Control, performing pre-release functional testing in multiple environments, review of content in Veeva Quality Docs and QMS systems. Creating new Doc types and classifications, appropriate metadata, and harmonizing data with other functional group leads. Ensure completeness and finalization status of documentation and ongoing CMC-related activities such as initiating change controls, creating new SOPs, editing/formatting, leading document adjudications and managing final workflows for document approval. Actively participate in FDA Inspections, creating reports and supporting record retrievals. Support CMC during mock inspection training. Designated SME for eTMF reconciliation and collaborating efforts with CRO

Manage regulatory data in various database system(s) for clinical and authorized medicinal product. Collect and manage data in support of submission operations including performing system searches and preparing specialized reports. Coordinate documentation to support stakeholder(s) and technical regulatory lead with complex submission activities. This includes compilation of complex and semi-complex regulatory dossiers. Maintain and update product lifecycle and lifecycle management (MFTOC, Living Dossier and CTD). Advise on new product metadata. Collaborate with SMEs all Document Change Controls, ensuring accuracy, justifications and metadata. Prepare and update technical regulatory documents specific to Module 3 (CMC). Manage submission documents to ensure adherence to applicable regulatory (eCTD) and Roche CMC documentation standards. Extensive knowledge and experience with eCTD TOC, Headings, Hierarchy and granularity. Edit and format documents, complex data tables, figures in accordance with Roche Style Guide, Gram Style Guide and as applicable to specific HA Guidance(s). Ensure methods, tools, and techniques are utilized correctly to maximize efficiency and effectiveness. Perform quality review and compliance crosscheck, ensure information is accurate and up to date. Maintain regulatory documents in document-management systems (IDM, D2, GPRS) and document-sharing systems (SharePoint, TouchPoint). Maintain global share drive folders. Coordinate with the respective publisher the dossier for publishing, metadata and product lifecycle alignment. Collaborate with Pharma Technical Regulatory (PTR) product managers and with internal partners. Actively participate in KPI initiatives on process automation, system enhancements, new system implementations, business process updates in addition to SOP and Work Instructions. Passionately supported various process optimization projects and pilot submissions.

Manage document-level publishing in accordance with various guidance(s) for Class IV medical devices. Manage paper submission and production, overall planning, print production, quality control, assembly and delivery. In collaboration with senior regulatory staff, manage, design, publish, review, submit and archive of large PMA and IDE submissions, including amendments and original filings. Liaise with Regulatory Affairs staff to coordinate submission life cycle, develop timelines and specifications. Develop and implementation of Regulatory Affairs archiving system. Maintain international registration tracker. Author submission templates in accordance with medical and regulatory writing style guides in addition to editing, formatting and publishing submission documents. Assist Regulatory Affairs personnel with document-level requirements and techniques.

Coordinate all aspects of exporting cased/bulk wine products to foreign markets. Work closely with overseas customers and Export Sales Director(s) – analyzing order to maximize shipping efficiencies. In addition to coordination of high volume production orders, duties included instructing repack dept. of bottle/case/pallet changes. Extensive research and iInterpreting export requirements for labeling, packaging and shipping requirements including review of package designs. Extensive communication with freight forwarders, coordinating logistics and negotiate shipping/inland rates. Creation and completion of all documentation required to ship wine from the U.S. to foreign customers (Ocean Bills of Lading, VI1, Analysis, Certificates of Origin/Free Sale, POSM Invoices, etc.). Work with consulates and foreign embassies insuring required documents are approved. Assist Compliance team with Withdrawal Report and Log, generating 5100.11 and Certificates of Receipts.

Writing services (any and all) including word processing, various reports and technical documentation, legal documents and presentations. The technical documentation and writing services are not defined but created with experience, knowledge and expertise in various industries. There are unique needs for specific writing and presentations, let me help you.

Support all client/customer requests for post test data and compliance test reports for product and safety test laboratory. Developed templates to support the specific testing requirements. Researched specific standards required for appropriate report format and data /documentation requirements. Responsible for creation and implementation of report automation process. Worked with Quality Engineer to streamline multiple operation processes identified as inefficiencies and redundant tasks. Successfully created a functional database for collecting EUT test data and tracking report status. Automation of systems to extract data and populate report templates.