Dossier Specialist at Eurofins

Spring House, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

19 Aug, 26

Salary

0.0

Posted On

21 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Nonclinical Research Reporting, eSub Readiness, SEND Data Packages, CDISC, PHUSE, Quality Control, Document Management Systems, Regulatory Compliance, FDA Guidelines, EMA Guidelines, OSHA Guidelines, MS Excel, Acrobat PDF, Cross-functional Collaboration, Data Review

Industry

Medical and Diagnostic Laboratories

Description

Company Description 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. Job Description 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 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. 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 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. 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.

Responsibilities

Prepare and process nonclinical research reports for electronic submission while ensuring compliance with internal and regulatory standards. Perform quality checks on SEND electronic data packages and generate datasets and reviewer's guides for internal studies.