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.

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.

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.

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.

* 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.

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.

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.*.
• 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.

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

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