Dossier Specialist Nonclinical Submissions
Eurofins USA PSS Insourcing Solutions, Spring House, Pennsylvania, United States, 19477
Overview
Job Description Responsibilities
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:
Internal and CRO study reports
All nonclinical sub-areas and clinical bioanalysis
Client-owned and purchased/co-developed products
Ensure that all assignments comply with the internal and regulatory standards.
Interact with all levels of the organization to meet submission timelines.
Support the various Therapeutic Areas with a focus on eSub-readiness of reports and submission documents.
Draft and update Content Plans, Advanced Component Reports and the Study Tagging Files to supplement the dossier plan for submissions.
Help Study Directors, NCS leaders, etc. to find documents in applicable document management system(s).
Support and coach all users of applicable document management system within PSTS.
Qualifications
A minimum of an associate’s degree with 5 years Pharma experience, or a bachelor’s degree with at least 3 years Pharma experience
Hands-on experience with Document Management Systems (DMS): locating/routing documents, user support, account requests, and basic administration.
Proven experience in preparing, finalizing, and processing nonclinical study reports (internal and CRO) and submission documents.
Familiarity with eSubmission concepts (Content Plan/Advanced Component Report, Study Tagging Files) and electronic submission
Advanced Microsoft Word skills (templates, styles, bookmarking, hyperlinks) and experience with Acrobat/PDF publishing.
Experience performing technical QC of documents and ensuring alignment with internal/regulatory format standards.
Must have strong interpersonal skills including effective listening, as well as clear oral and written communication, provide technical mentorship to authors in providing e-submission ready documents.
Authorization to work in the United States indefinitely without restriction or sponsorship.
Additional Information
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 insurance
401(k) with company match
Paid vacation and holidays
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
#J-18808-Ljbffr
Job Description Responsibilities
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:
Internal and CRO study reports
All nonclinical sub-areas and clinical bioanalysis
Client-owned and purchased/co-developed products
Ensure that all assignments comply with the internal and regulatory standards.
Interact with all levels of the organization to meet submission timelines.
Support the various Therapeutic Areas with a focus on eSub-readiness of reports and submission documents.
Draft and update Content Plans, Advanced Component Reports and the Study Tagging Files to supplement the dossier plan for submissions.
Help Study Directors, NCS leaders, etc. to find documents in applicable document management system(s).
Support and coach all users of applicable document management system within PSTS.
Qualifications
A minimum of an associate’s degree with 5 years Pharma experience, or a bachelor’s degree with at least 3 years Pharma experience
Hands-on experience with Document Management Systems (DMS): locating/routing documents, user support, account requests, and basic administration.
Proven experience in preparing, finalizing, and processing nonclinical study reports (internal and CRO) and submission documents.
Familiarity with eSubmission concepts (Content Plan/Advanced Component Report, Study Tagging Files) and electronic submission
Advanced Microsoft Word skills (templates, styles, bookmarking, hyperlinks) and experience with Acrobat/PDF publishing.
Experience performing technical QC of documents and ensuring alignment with internal/regulatory format standards.
Must have strong interpersonal skills including effective listening, as well as clear oral and written communication, provide technical mentorship to authors in providing e-submission ready documents.
Authorization to work in the United States indefinitely without restriction or sponsorship.
Additional Information
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 insurance
401(k) with company match
Paid vacation and holidays
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
#J-18808-Ljbffr