Eurofins PSS Insourcing Solutions · 6 hours ago
SEND Data Management Submissions Support Specialist
Spring House, PA
Full-time
Onsite
Mid Level
3+ years expEurofins Scientific is an international life sciences company providing analytical testing services across multiple industries. The SEND Data Management Submissions Support Specialist will work independently and within cross-functional teams to ensure compliance with internal and regulatory standards, perform quality checks on SEND electronic data packages, and generate SEND datasets for nonclinical studies.
Biotechnology
No H1B
Responsibilities
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/leaders
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
Read, understand, and follow through on all correspondences
Interact with all levels of the organization to meet submission timelines
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
Qualification
Required
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
Preferred
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
Benefits
Comprehensive medical coverage
Dental
Vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays
Company
Eurofins PSS Insourcing Solutions
Welcome to Eurofins Professional Scientific Services® (PSS), where we redefine industry norms in insourcing solutions, creating unparalleled value for both our dedicated employees and esteemed clients.
1001-5000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase