Specialist 4 Quality Research and Development
Job Location:
West Chester, OH - USA
Monthly Salary:
Not provided by the employer
Posted:
16 June 2026 (30+ days ago)
Application Deadline:
13 September 2026
Vacancies:
1 Vacancy
Job Summary
Position Details:
Our client a world-leading Pharmaceutical Company in West Chester PA is currently looking for a Sr. Business Analyst to join their expanding team.
Job Title: Sr. Business Analyst / Clinical Trials GCP documentation / Remote Work
Duration: 12 months contract extendable up to 24 Months
Location: West Chester PA
Duration: 12 months contract extendable up to 24 Months
Location: West Chester PA
HYBRID preferred (3 days onsite in West Chester PA); can be remote in EST time zone for ideal candidate
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Notes:
HYBRID preferred (3 days onsite in West Chester PA); can be remote in EST time zone for ideal candidate
position may go into 2027 if needed
Possible titles: Business Process Mgmt or Quality Process Mgmt
Bachelors degree required
Work with external groups/teams
Help setup meetings
Will speak and communicate with R&D business partners
Will help with training and curriculum
Will help with drafting communications for trainings
Will perform quality checks on documents
Must understand process mapping
Will assist with writing process documents
Must understand GCP content in document (good clinical practice)
Will be getting info out of business partner and must understand it to put it into documents
HYBRID preferred (3 days onsite in West Chester PA); can be remote in EST time zone for ideal candidate
position may go into 2027 if needed
Possible titles: Business Process Mgmt or Quality Process Mgmt
Bachelors degree required
Work with external groups/teams
Help setup meetings
Will speak and communicate with R&D business partners
Will help with training and curriculum
Will help with drafting communications for trainings
Will perform quality checks on documents
Must understand process mapping
Will assist with writing process documents
Must understand GCP content in document (good clinical practice)
Will be getting info out of business partner and must understand it to put it into documents
Description:
Position Title PDM PPQME Contractor
Position Title PDM PPQME Contractor
Essential Job Duties and Responsibilities
This position reports into Process and Data Management (PDM) within IM Quality Systems.
The PDM-PPQME Contractor is responsible for supporting clinical R&D and/or device business process owners in the end-to-end process for procedural document development and compliance training development and deployment in the Quality Management System (QMS) framework.
This position reports into Process and Data Management (PDM) within IM Quality Systems.
The PDM-PPQME Contractor is responsible for supporting clinical R&D and/or device business process owners in the end-to-end process for procedural document development and compliance training development and deployment in the Quality Management System (QMS) framework.
Responsibilities include:
Define and manage project plans tasks schedules scope timelines and deliverables.
Perform project management across the life cycle from procedural document development and approval (in EDMS) to training identification target audience identification training material development and training deployment (in LMS).
Perform quality check of procedural documentation and provide feedback to business partners for consideration.
Ongoing communication with business owners on project progress and resolution of issues.
Work with peers in PDM to ensure compliant training and procedural documents are installed for dedicated processes.
Define and manage project plans tasks schedules scope timelines and deliverables.
Perform project management across the life cycle from procedural document development and approval (in EDMS) to training identification target audience identification training material development and training deployment (in LMS).
Perform quality check of procedural documentation and provide feedback to business partners for consideration.
Ongoing communication with business owners on project progress and resolution of issues.
Work with peers in PDM to ensure compliant training and procedural documents are installed for dedicated processes.
Minimum Qualification
College Degree Required minimum of 5 years experience in medium to large organization.
Strong ability to problem solve and think critically.
Ability to work collaboratively with a large group of internal and external colleagues and partners.
Ability to multi-task and manage a large volume of projects
Strong attention to detail and highly organized works independently
Strong written and verbal communications.
Proficient in MS Office products (Outlook Word Excel PowerPoint)
College Degree Required minimum of 5 years experience in medium to large organization.
Strong ability to problem solve and think critically.
Ability to work collaboratively with a large group of internal and external colleagues and partners.
Ability to multi-task and manage a large volume of projects
Strong attention to detail and highly organized works independently
Strong written and verbal communications.
Proficient in MS Office products (Outlook Word Excel PowerPoint)
Other requirements
The PPQME should have experience working with automated systems especially Electronic Document Management Systems (EDMS) and Learning Management Systems (LMS).
The PPQME should have experience working with automated systems especially Electronic Document Management Systems (EDMS) and Learning Management Systems (LMS).