Dossier Specialist

• 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 Reviewers 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.

Qualifications :

• Minimum of a high school diploma with 5 years Pharma experience or a bachelors 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.

Additional Information :

Position is full-time Mon-Fri 9am-5pm. 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 insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

No

Employment Type :

Full-time