SEND Data Management Submissions Support Specialist

Eurofins USA PSS Insourcing Solutions•Spring House, PA

7d•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. 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.

Requirements

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.
Strong expertise in areas of GLP/GCP compliance is preferred.

Nice To Haves

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.

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.

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

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