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Regulatory Assistant - Per Diem

Pharmaceutical Product Development (PPD)

US-FL-Orlando

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.  At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!

Phase Itrials represent the first practical tests of a compound’s clinical relevance and commercial viability. They are the culmination of years or even decades of research. Moreover, they set the stage for subsequent studies that will ultimately determine your compound’s efficacy, safety and positive impact on patient’s lives.

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:

As a RegulatoryAssistant (Project Assistant), you will provide technical and administrative support PPD's Phase I Clinical Research Unit in Orlando, FL.You work with a high attention to detail, reviewing documentation, coordinating project details, and maintaining data systems - all with a sense of urgency aligned with that of our customers.

The basic purpose of the Project Assistant is to provide technical support to the regualtoryteam. Will coordinate non-clinical responsibilities of project administration as applicable to the client contract under the direction of their manager.

This is a PRN/ per diem role. 2-4days/ week.Day shift.

Responsibilities include, but are not limited to; Reviews regulatory documents for proper content Performs PPD investigator file reviews and logging of outstanding issues in project related tracking tools Liaises with monitor and investigative sites to resolve outstanding regulatory issues identified Disseminates study related information, including project tracking updates to Clients, clinical study teams and other PPD departments Assists with the identification of potential investigators and development/distribution of initial protocol packets Creates meeting agendas and minutes Coordinates team conference calls and distribution of meeting minutes

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk - our award winning training programs speak for themselves.

To learn how PPD can advance your career, apply now!

What To Expect Next:We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.  At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!

Phase Itrials represent the first practical tests of a compound’s clinical relevance and commercial viability. They are the culmination of years or even decades of research. Moreover, they set the stage for subsequent studies that will ultimately determine your compound’s efficacy, safety and positive impact on patient’s lives.

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:

As a RegulatoryAssistant (Project Assistant), you will provide technical and administrative support PPD's Phase I Clinical Research Unit in Orlando, FL.You work with a high attention to detail, reviewing documentation, coordinating project details, and maintaining data systems - all with a sense of urgency aligned with that of our customers.

The basic purpose of the Project Assistant is to provide technical support to the regualtoryteam. Will coordinate non-clinical responsibilities of project administration as applicable to the client contract under the direction of their manager.

This is a PRN/ per diem role. 2-4days/ week.Day shift.

Responsibilities include, but are not limited to; Reviews regulatory documents for proper content Performs PPD investigator file reviews and logging of outstanding issues in project related tracking tools Liaises with monitor and investigative sites to resolve outstanding regulatory issues identified Disseminates study related information, including project tracking updates to Clients, clinical study teams and other PPD departments Assists with the identification of potential investigators and development/distribution of initial protocol packets Creates meeting agendas and minutes Coordinates team conference calls and distribution of meeting minutes

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk - our award winning training programs speak for themselves.

To learn how PPD can advance your career, apply now!

What To Expect Next:We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.

Qualifications Education and Experience: Bachelor's Degree or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities Phase I or clinical research experience preferred Knowledge, Skills and Abilities: Excellent 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 Responsible for adhering to FDA Good Clinical Practices, FDA regulations, PPD/Client Standard Operating Procedures and Working Practice Documents regulations for all non-clinical/clinical aspects of project implementation, execution, and closeout Excellent English and grammar skills Excellent computer skills, proficient in MS Word, Excel, PowerPoint and ability to obtain knowledge and master all clinical trial database systems Ability to successfully complete PPD clinical training program (CAFT- Clinical Administration Foundation Training) Ability to mentor and train new Project Assistants as needed

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 for typical working hours Ability to use and learn standard office equipment and technology with proficiency Able to perform successfully under pressure while prioritizing and handling multiple projects or activities May require travel (Recruiter will provide more details)

Qualifications Education and Experience: Bachelor's Degree or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities Phase I or clinical research experience preferred Knowledge, Skills and Abilities: Excellent 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 Responsible for adhering to FDA Good Clinical Practices, FDA regulations, PPD/Client Standard Operating Procedures and Working Practice Documents regulations for all non-clinical/clinical aspects of project implementation, execution, and closeout Excellent English and grammar skills Excellent computer skills, proficient in MS Word, Excel, PowerPoint and ability to obtain knowledge and master all clinical trial database systems Ability to successfully complete PPD clinical training program (CAFT- Clinical Administration Foundation Training) Ability to mentor and train new Project Assistants as needed

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 for typical working hours Ability to use and learn standard office equipment and technology with proficiency Able to perform successfully under pressure while prioritizing and handling multiple projects or activities May require travel (Recruiter will provide more details)

Job posted: 2021-04-14

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