Kristal L. Sheldon Email and Phone Number

• Actively engages with multiple stakeholders throughout the company regarding document processing procedures and communicates the benefit of strategies which support the publishing and broader regulatory team.• Assists in the implementation of planned document processes which appropriately utilize approaches including, but not limited to, communicating enhanced digital system capabilities, and/or other service offerings which optimize the authoring team experience and document submission timelines.• Serves as a lead contributor to the ongoing development, maintenance, and enhancement of internal guides for document processing and publishing.• Liaise with assigned Dossier Managers to provide quality control support of dossiers prior to submission to health authorities• Supports authors and new publishers by providing guidance and on the spot training for the Regulatory Information System (Veeva Rim Vault), MS Office (ie: Word, Adobe) and Health Authority document requirements.• Member of the change control committee for Veeva RIM Vault. Review requests and collaborate with members to implement requested changes to improve system improvements for document writing, review, and approval for all regulatory documents.• Lead project assignment meetings to track large project request completion and ensure fair distribution of workload.• Partners and actively collaborates with internal department designees to ensure awareness of and alignment with ongoing document processing activities and requirements.

• Actively engage with multiple stakeholders throughout internal and client department, and the broader clinical trial team regarding document processing strategies and communicates the benefit of tactics that support the writing and editing team.• Assist in the implementation of planned document processing strategies which appropriately utilize tactics including, but not limited to, communicating enhanced digital system capabilities, and/or other service offerings which optimize the authoring team experience and document submission timelines.• Partner with department and client leads to ensure awareness of priorities, operational timelines and learnings via creation and maintenance of required SharePoint sites. Contributes to the development of team sites and process plan releases as needed. Liaisons with SharePoint IT to ensure site functionality.• Actively support technical capabilities of the document templates through membership and/or engagement with client efforts as a member of the Model Document Management Team. • Serve as a contributor to the development, maintenance, and enhancement of internal and client Study Operating Procedures for clinical document processing. Actively participate in change management discussions to improve document writing, review, and publishing cycle time for global submissions.• Collaborate with internal and client department leads to ensure awareness of and alignment with ongoing document processing activities and requirements. • Calculate and report finalized and in-process document metrics for internal and client management teams.• Support writing teams by providing guidance and on the spot training for document management system, MS Office Suite and official document processes.• Conduct new writer and editor introduction meetings for the technical editor team, as well as provide guidance to new technical editor team members.• Communicate and serve as a document system SME for internal and external audits.

• Review and format clinical and regulatory documents including but not limited to protocols, amendments, charters and administrative letters per BMS and Health Authority standards• Ensure that documents are submission ready for each review committee and finalization for submission to domestic and global health authorities• Train protocol writing teams on technical and formatting of documents and assist when questions arise• Provide guidance for writing teams on the internal review processes• Create and maintain multiple SharePoint pages ensuring updated information is available to teams

Hybrid role of specialized services and protocol technical specialist duties.- Assist protocol writing teams with technical and formatting questions- Support the clinical trials team with the integration of the Siebel Clinical data system.- Set-up of site personal roles for IVRS in Impact- One of the data liaisons between our CRO partners and BMS for site information updates- Create and maintain multiple SharePoint pages ensuring updated information is available to teams

- Review and format clinical protocols per BMS and FDA standards ensuring that documents are submission ready for each review committee- Assist and train protocol writing teams with technical and formatting questions- Serve as a super user for the Consolidated Authoring, Reviewing & Approval System (CARA)- Creator of the Protocol Technical Specialist (PTS) Team SharePoint

Specialized Services CTA overseeing up to five studies in multiple phases.- Index BMS managed documents into Electronic Study File (ESF) system- Enter start-up site data into Global Investigator Directory (GID) and Impact systems- Enter complete FDA 1572 forms and Site Contact and Information Sheet entries into Impact- Set-up of site personal roles for IVRS in Impact- Work closely with Project CTA and Site Managers to ensure all documents are received and entered into systems- Work with Study Files Management to ensure alignment is maintained in ESF- Perform reconciliation of requested study information in Impact and regulatory tracking system (IRIS) against official 1572s for Clinical Study Reports (CSR)- Assist with ESF searches for FDA audit requests- Mentored and integrated three new SS CTAs- Co-Creator of the Clinical Trials Associate (CTA) Team SharePoint- CTA contributor for the Clinical Trials Process (CTP) and Department (GDO&S) SharePoint sites

Reporting to Oncology Clinical Research Group Director and four Medical Monitor direct-reports- Perform diverse administrative duties, which involve high-level contacts and exposure to sensitive information as well as meeting demanding deadlines.- Manage multiple calendars on a day-to-day basis, including time allocations for managers, scheduling of meetings over multiple time zones including scheduling audio/visual conferences.- Arrange extensive domestic and international travel arrangements, visa/passport applications, and preparation of corresponding expense reports.- Assist in preparing agendas, presentations, consulting agreements, memoranda, correspondence and finalizing meeting minutes.- Key player in the coordination of MD candidate scheduling, which includes agenda preparation, travel arrangements, and seminar support. Handling of strict confidential materials/information required. • Post meeting materials for multiple meetings on multi company shared access website• Support to Medical Monitor team during European and US filing preparations (product was eventually approved)- Maintain project team and meeting attendee lists

Support to multiple clinical drug development teams in the Central Clinical Operations group.- Manage multiple calendars on a day-to-day basis, including time allocations for managers, scheduling of meetings over multiple time zones including scheduling audio/visual conferences.- Perform diverse administrative duties, which involve high-level contacts and exposure to sensitive information as well as meeting demanding deadlines- Arrange extensive domestic travel arrangements and preparation of corresponding expense reports- Assist in preparing agenda and meeting minutes, presentations and correspondence- Post meeting materials for multiple meetings on multi company shared access website- Maintain project team and meeting attendee lists

Temporary position at Bristol-Myers Squibb supporting three recruiters for a site with 1200+ personnel.- Data entry for all applicants, including new hire personal information, interviews and offers in Deploy applicant tracking system- Create, open and close job requisition files in Deploy, Access, Excel and job folders- Post open job descriptions on numerous recruitment websites- Assist in organizing job fairs by creating and organizing materials for all available positions- Aid recruiters in applicant sourcing by identifying appropriate candidates using multiple recruiting sites- Prepared new hire personnel files with all relevant documents (ie, applications/resumes, new hire paperwork, etc)- Tracked Employee Referral payment program and sent notification for payment- Coordinate New Hire Orientation, including notification packages, reserving conference rooms, teleconference lines and catering

Support to three recruiters for a 500+ sales team- PeopleSoft data entry for applicants, new hires, employee status changes, terminations as well as used the query and report functions- Open and close job requisition files in PeopleSoft and job folders- Assist recruiter in job postings as well as applicant sourcing by identifying appropriate candidates using multiple online recruiting sites- Aid recruiter in pre-screen interviews- Conduct written and verbal employment verifications- Maintain personnel files for current and past employees- Facilitate the processing of Unemployment Claims- Conduct New Hire Orientation and process new hire paperwork- Tracked Education Reimbursement program, checked that courses were completed with passing grade and sent notification for payment

Support to HR Executive Director and Assistant Director for a 500+ personnel site.- Input of all information into PeopleSoft (entry of new hires, employee status changes, benefits, training, terminations) as well as used the query function- Processed new hire paperwork, verified previous employment, background checks and I-9 documents- Reviewed and tracked all applications in Applicant Flow Tracker System- Maintained personnel hard files for current and past employees- In charge of display boards, tracking team member travel program and education reimbursement, employee recognition programs and special projects as assigned- Promoted to Human Resources from Front Office

Internship with Unemployment Department- Presented overview presentations on available state programs- Assisted job seekers writing resumes- Provided back-up support for front desk- Trained incoming employees on EDD Cal Jobs system