SEND Data Management Submissions Support Specialist

Spring House, PA - USA

Monthly Salary: Not Disclosed

Posted on: 9 hours ago

Vacancies: 1 Vacancy

Job Summary

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 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.
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.

Qualifications :

Minimum of an associates degree 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.
Effective communicator and organizational skills.

Demonstrates learning agility.
Excellent interpersonal organizational verbal and written communication skills are required.
Hands-on experience with SEND (CDISCs Standard for Exchange of Nonclinical Data) a plus.
Advanced Microsoft Word skills (templates styles bookmarking hyperlinks) and experience with Acrobat/PDF publishing a plus.
Strong expertise in areas of GLP/GCP compliance is preferred.

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.

Remote Work :

Employment Type :

Full-time

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/leadersEnsure that all assignments comply with the internal and regulatory standards.For outsourced Non...

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 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.
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.

Qualifications :

Minimum of an associates degree 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.
Effective communicator and organizational skills.

Demonstrates learning agility.
Excellent interpersonal organizational verbal and written communication skills are required.
Hands-on experience with SEND (CDISCs Standard for Exchange of Nonclinical Data) a plus.
Advanced Microsoft Word skills (templates styles bookmarking hyperlinks) and experience with Acrobat/PDF publishing a plus.
Strong expertise in areas of GLP/GCP compliance is preferred.

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.

Remote Work :

Employment Type :

Full-time

Key Skills

Children Activity
Access Control
Human Resources Administration
Government
Actuary
Hydraulics

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About Company

Eurofins

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 the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eur ... View more

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