About this role
Ability to work independently as well as participate within cross-functional teams including global interactions in different time zones.Interact with immediate supervisor and project team members/leadersEnsure 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.Read, understand, and follow through on all correspondences.Interact with all levels of the organization to meet submission timelinesParticipate in CDISC/PHUSE working group subteamsEnsure 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. Minimum of an associate’s degree with 5 years Pharma experience, or a bachelor's degree with at least 3 years Pharma experience (degree in biology, biochemistry or other relevant scientific concentration a plus).Authorization to work in the United States indefinitely without restrictions or sponsorship.Effective communicator, and organizational skills.Demonstrates learning agility.Excellent interpersonal, organizational, verbal and written communication skills are required.Hands-on experience with “SEND” (CDISC’s “Standard for Exchange of Nonclinical Data”) a plus.Advanced Microsoft Word skills (templates, styles, bookmarking, hyperlinks) and experience with Acrobat/PDF publishing a plus.Strong expertise in areas of GLP/GCP compliance is preferred. Position is Full Time, Mon-Fri 8am-5pm with overtime as needed. Candidates currently living within a commutable distance of Spring House, PA are encouraged to apply.
Excellent full time benefits including comprehensive medical coverage, dental, and vision options.
Life and disability insurance401(k) with company matchPaid vacation and holidaysEurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.