Dossier Specialist

Eurofins USA PSS Insourcing Solutions•Spring House, PA

3d•Onsite

About The Position

Read, understand and follow through on all correspondences, with the ability to work independently as well as participate within cross-functional teams including global interactions in different time zones. Prepare, finalize and process all nonclinical research reports for electronic submission (eSub)-readiness in applicable document management systems Ensure that all assignments comply with the internal and regulatory standards. For outsourced Nonclinical studies, perform in-depth quality checks on SEND (Standard for Exchange of Nonclinical Data) electronic data packages. For internal Nonclinical studies, generate SEND datasets via internal computer systems and write corresponding Nonclinical Study Data Reviewer’s Guide (nsdrg) in Word/Acrobat PDF. Inform/discuss with team any potential risks, issues and/or opportunities for improvement. Document QC work completed in “Global SEND Planning list” (MS Excel) and other related activities. Participate in CDISC/PHUSE working group subteams Ensure procedural documents are reviewed and updated as required per established timelines. Perform tasks in compliance with all local, state and federal regulations and guidelines including but not limited to FDA, EMA, and OSHA; Comply with all company and site policies and procedures.

Requirements

Minimum of a high school diploma with 5+ years Pharma experience, or a bachelor's degree with at least 3 years Pharma experience
Authorization to work in the United States indefinitely without restrictions or sponsorship.

Nice To Haves

degree in biology, biochemistry or other relevant scientific concentration a plus

Responsibilities

Prepare, finalize and process all nonclinical research reports for electronic submission (eSub)-readiness in applicable document management systems
Ensure that all assignments comply with the internal and regulatory standards.
For outsourced Nonclinical studies, perform in-depth quality checks on SEND (Standard for Exchange of Nonclinical Data) electronic data packages.
For internal Nonclinical studies, generate SEND datasets via internal computer systems and write corresponding Nonclinical Study Data Reviewer’s Guide (nsdrg) in Word/Acrobat PDF.
Inform/discuss with team any potential risks, issues and/or opportunities for improvement.
Document QC work completed in “Global SEND Planning list” (MS Excel) and other related activities.
Participate in CDISC/PHUSE working group subteams
Ensure procedural documents are reviewed and updated as required per established timelines.
Perform tasks in compliance with all local, state and federal regulations and guidelines including but not limited to FDA, EMA, and OSHA; Comply with all company and site policies and procedures.