Roles & Responsibilities: Master's degree in fields such as outcomes research, epidemiology, biostatistics, data science, predictive analytics or doctoral degree (PhD, DrPH, ScD). At least 5 years of experience programming with R or Pyth...
Responsibilities: Develop and QC TFLs for protocols/reports/manuscripts from RWE research conducted to assess the value of the client's therapies using RWD (e.g. claims and EHR). QC programming for descriptive and complex studies using R...
Responsibilities: Secondary Data Study Protocol Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and study report: Supports statistical activities for studies including study design, protocol dev...
Develop, validate, and implement analytical test methods for combination products in compliance with regulatory standards and internal quality requirements. Collaborate cross-functionally with device engineers, laboratory teams, and qualit...
Expert in CSA validation principles. Automated testing experience a must Develop a strategy to convert existing CSV approaches to lab validation into a CSA documented process. Developing, reviewing, and executing testing documentation. ...
CSV for SAP systems/projects To create| assign and track the project [module] work plans for delivery and also provide technical guidance for work completion. (1.) To ensure process improvement and compliance in the assigned module| and ...
Responsibilities: To create| assign and track the project [module] work plans for delivery and provide technical guidance for work completion. Ensure process improvement and compliance in the assigned module| and participate in technical...
Contract Description Requires Project Management experience with a focus on GxP systems or validated systems. Involves responsibilities in stakeholder management and excellent communication skills. Necessitates experience in QC Lab, MES,...
Responsible for managing end-to-end CSV deliverables for both new & existing applications. Responsible for Implementation of Lab, Enterprise and Manufacturing systems and supporting change management of existing systems. Manage and suppor...
Responsibilities: Serve as the primary support for the MES Syncade system, ensuring its seamless integration with manufacturing processes. Develop a deep understanding of manufacturing workflows to optimize and enhance processes with MES...
Job Description: Qualifications: Bachelor's degree in Quality Management, Regulatory Affairs, Life Sciences, or a related field. Minimum of 5 years of experience in QMS, quality assurance, regulatory compliance, or related roles. Softw...
Responsibilities: Provides SAS programming support to all clinical studies. Manages assigned programming CROs providing oversight and appropriate QC for programming deliverables. Provide statistical programming support for regulatory su...
Responsibilities: Lead computer system validation projects related to authoring and executing specifications and validation documentation for enterprise computer systems. Author validation protocols ensuring that the technology solutions...
Roles & Responsibilities: 2-5 years of experience in a Quality Engineering or similar role within an FDA regulated industry preferably medical device and diagnostics that includes experience with CAPA and auditing processes. Participate ...
Responsibilities: Demonstrated practical understanding of SAS programming concepts and techniques appropriate to the pharmaceutical industry. Demonstrated satisfactory ability to apply SAS programming knowledge and work independently to ...
4 to 5 years of Supplier Development experience Experience in working in New Product Introduction Good experience in Component Qualification (plastics & sheet metal) Experience in Process Validations (IQ/OQ/PQ) Experience in Test Method...
Responsibilities: Designing and executing validation including support of computer system validation protocols to ensure consistency of data production and compliance with client's quality standards (including internal ISPE referenced gui...
Responsibilities: Support the planning, setup, and acquisition of external clinical data at the study level, assisting in managing study start-up, conduct, and closeout activities. Assist in creating external data transfer agreements, en...
Roles & Responsibilities: 8 yrs of experience on clinical trial data analysis using SAS. Preferably in UNIX environment Familiar with UNIX command and environment. Deep knowledge on CDISC Standards and solid ADaM programming experience. ...
Responsibilities: Support the planning, setup, and acquisition of external clinical data at the study level, assisting in managing study start-up, conduct, and closeout activities. Assist in creating external data transfer agreements, en...