Records Specialist

Title: Records Specialist

Department: Quality Assurance

Location: Middleton, Wisconsin

PPD’s mission is to improve health . It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams .

About the Department:

Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD® Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success.

About the Position:

The purpose of the Records Specialist position is to provide subject matter expertise supporting various aspects of PPD's Global Records program in order to continue the development, maintenance, and roll-out of the program. Personnel will help ensure that PPD has a legally-defensible, regulatory compliant Global Records program.

A bout our Culture, Career Advancement and Benefits:

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Summarized Purpose:

Provides general global records management (GRM) and file room support by working closely with global project teams to ensure all global records management tasks are completed according to organization and/or client standard operating procedures (SOP) and working practice documents (WPD), and provides broad technical assistance to study teams.

Essential Functions; Processes (scans/images, indexes, files) incoming study documents (paper and/or electronic). Assists study teams as required per WPD/SOP with archival of all documents supporting the bioanalytical project. Acts as the study team subject matter expert on the archival process for assigned studies. Liaises with the study team and study director to resolve outstanding issues identified during project archival and/or quality reviews. Provides extensive technical support for the study team when initiating project archival. Maintains and updates products and systems associated with global records classification, retention and disposition. Conducts training for department staff, company employees, and clients. Assists with applicable sponsor deliverables.

#GD

#LI-AP1

PPDLABS Title: Records Specialist

Department: Quality Assurance

Location: Middleton, Wisconsin

PPD’s mission is to improve health . It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams .

About the Department:

Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD® Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success.

About the Position:

The purpose of the Records Specialist position is to provide subject matter expertise supporting various aspects of PPD's Global Records program in order to continue the development, maintenance, and roll-out of the program. Personnel will help ensure that PPD has a legally-defensible, regulatory compliant Global Records program.

A bout our Culture, Career Advancement and Benefits:

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Summarized Purpose:

Provides general global records management (GRM) and file room support by working closely with global project teams to ensure all global records management tasks are completed according to organization and/or client standard operating procedures (SOP) and working practice documents (WPD), and provides broad technical assistance to study teams.

Essential Functions; Processes (scans/images, indexes, files) incoming study documents (paper and/or electronic). Assists study teams as required per WPD/SOP with archival of all documents supporting the bioanalytical project. Acts as the study team subject matter expert on the archival process for assigned studies. Liaises with the study team and study director to resolve outstanding issues identified during project archival and/or quality reviews. Provides extensive technical support for the study team when initiating project archival. Maintains and updates products and systems associated with global records classification, retention and disposition. Conducts training for department staff, company employees, and clients. Assists with applicable sponsor deliverables.

#GD

#LI-AP1

PPDLABS

Education and Experience: High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification, Associate's degree preferred Technical positions may require a certificate Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).

Knowledge, Skills and Abilities: Sophisticated communication and interpersonal skills Excellent organizational skills and strong attention to detail with proven ability to handle multiple tasks efficiently and effectively Ability to effectively analyze project specific data/systems to ensure accuracy and efficiency Flexibility to reprioritize workload to meet changing project timelines Firm understanding of applicable systems including document management software and the eTMF Advanced computer skills

Working Environment:

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary and/or standing for typical working hours. Able to lift and move objects up to 25 pounds Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD -

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you

Education and Experience: High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification, Associate's degree preferred Technical positions may require a certificate Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).

Knowledge, Skills and Abilities: Sophisticated communication and interpersonal skills Excellent organizational skills and strong attention to detail with proven ability to handle multiple tasks efficiently and effectively Ability to effectively analyze project specific data/systems to ensure accuracy and efficiency Flexibility to reprioritize workload to meet changing project timelines Firm understanding of applicable systems including document management software and the eTMF Advanced computer skills

Working Environment:

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary and/or standing for typical working hours. Able to lift and move objects up to 25 pounds Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD -

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you