Dossier Specialist (Nonclinical Submissions)

Eurofins • Spring House, PA

2d • Onsite

About The Position

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.
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.

Requirements

• 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.

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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree