Daniel Peer Email & Phone Number

Plainfield, Ct, Us

Troy, Michigan, Us

-Regulatory Approval Database (RAD) RA Coordinator as a continued position within Depuy Synthes-Johnson and Johnson.- Coordinate RAD Team priorities, project and daily workload.-Train and coach new hires, external employees on RAD department processes and systems.-Create and manage team process flows and work instructions.- Drove innovation enhancements for RAD and reporting workload related to server and reporting systems.-Create & maintain Tableau reports/dashboards- RAD SME (subject matter expert) for Business unit integration in to RAD system.- Manage remote direct reports in US and oUS.- Built, maintained, and enhanced task tracking database (MS access) for RAD RA Team- assisting in process development and integration of Licensing and registration systems.

Troy, Michigan, Us

Continued contract position within Depuy Johnson and Johnson.*Update request tracking processes to ensure workload and status is documented.*Entere, maintains and validates regulatory approvals in the RAD system.*Provide secondary review of approval requirements during data validation.*Assist with special projects as required (example: Tableau data compiling).*Assist DIMI Team with Legal Manufacturer change documentation submission as required*Perform other duties as assigned.*Created streamline process tools for RAD team.*Created SOP documentation for training and reference material

Troy, Michigan, Us

(RAD) Admin contract position within Depuy Johnson and JohnsonPreformed tasks such as*Releasing restriction of country licensed variant data within the RAD system*Worked with other departments on RAD related inquiries *Assisted in RAD system upgrade testing within a QA/Development Environment*Assigned as Records Coordinator for RAD Department. Role involves organizing and scanning hard-copy documentation for digital archiving into SharePoint. In addition, maintained hard-copy archiving within Iron Mountain for record retention.

Continued Pfizer contract roles till end of contract.- Compiled pre and post drug related lifecycle submissions for United States and Canada. Worked closely with Strategy, Chemistry/Manufacturing/Controls (CMC) and publishing departments for drug lifecycle development and maintenance. Acted with high-level user rights managing mainframe data systems such as Global Document Management Systems (GDMS) creating, maintaining and acquiring lifecycle documentation.Was responsible for understanding and interpreting global, program, and departmental guidance. Assisted with logistic and efficacy review, proposed changes to guidance documents indicating the positive and negative departmental/stakeholder effects.

* Compiling builds of US/CA ECTD submissions from Fileshare/GDMS NextGen within ViewPoint.* Uses of Lorenz eValidator, ISI Toolbox to Review and QC published output prior to dispatch of submission.* Uses of eCTDXpress for recompiling updates to ECTD submissions.* Dispatch published ECTD submissions through FDA ESG system.* Working close with strategist and CMC in relations to submission build, review, dispatch, and scheduling.* Assist with fileshare drive cleanup project.* Assist with administrative services for reports and presentations.* Created CA regional specific on-boarding instruction for Pharmalink consulting, while assisting with Pfizer SOP Development within Pfizerpedia system

Tel-Aviv, Il

*Reviewed and finalized paper and hybrid digital submissions with processes involving ISI toolbox “Bookmark and Link Auditor” and “iOptimize”.*Submit electronic hybrid CTD submissions through the FDA’s ESG Gateway system.*Recorded, processed, and maintained paper and digital archives.*Primary contact for office document scanning project, *Managed outside contractor employees’ while ensuring company standards in quality and precision.*Created and modified departmental paper SOP’s and training/on-boarding documents.Training:*Completed - Liquent Education and Training - 3 Day Course*Day 1-2 - Publishing with Liquent InSight - Version 4.11*Day 3 - Advanced Publishing with Liquent InSight - Version 4.11

Tel-Aviv, Il

*Dispatch outgoing correspondence/Submissions to the FDA through the FDA’s ESG Gateway system or shipping services.* Record and distribute incoming FDA correspondence.* Processed requests for other departments .* Directly oversee organization of High Density records by recording, maintained paper and digital archives.Accomplishments:• Creating a strong personal bond with coworkers to maximize the efficiency of Regulatory Operations and shortening pending request time

* Overlooked scanning department operations for 175 legacy products.* Recorded and processed incoming and outgoing correspondence, including paper and digital archives.* Created digital ANDA/NDA/iPledge submissions including but not limited to book-marking, linking and pagination.* Prepared and overlooked hybrid electronic transmittal forms for dispatch to the FDA.* Prepared confidential paperwork.* Worked closely with various departments, as well as team members to obtain data for inclusion in various submissions. Accomplishments:* Conversion of over 150 paper based product history files to digital format* Created a digital archive for newly created digital files from paper based system

Troy, Michigan, Us

• Overlooked scanning department operations• Prepared complex presentations, including duplex prints, scanning, and tabs• Worked with confidential paperwork• Assisted in maintaining scanning office workflow• Converted ANDA paperwork into digital formats• Prepared digital and copied documents for FDA submission• Assisted co-workers

Troy, Michigan, Us

• Data entry of drug and labeling documents• Assisted co-workers with document storage

Bachelor Of Science In Business, Concentration In Management

Associate Of Arts, Concentration In Foundations Of Business