Roles & Responsibilities: Experience in complaint handling for combination products. Familiarity with Trackwise or Veeva. Strong communication skills. An Engineering background in education....
Responsibilities: Support design reviews, debugging, acceptance, and validation of equipment developed by external suppliers. Assist in decommissioning and recommissioning of equipment to ensure proper functionality and compliance. Co...
Responsibilities: Lead Generation & Client Acquisition: Identify and target potential clients through market research, networking, and cold calling. Develop and maintain a strong pipeline of new business opportunities. Set up meetings a...
Job Description: Analyze and evaluate current business processes, anticipate future requirements, identify areas for improvement, and develop and implement effective solutions. Utilize both formal and informal communication methods to st...
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...
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...
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. ...
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...
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...
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 ...
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,...
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...
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...