cGxPServe

Roles & Responsibilities: Knowledge in Troubleshooting MATLAB compatibility issues and technical issues. Strong Experience in CSV. Strong creative analytical and problem-solving skills. Experience in PLM Tool. Excellent Interpersonal / communication skills Organizational / planning s More...

Responsibilities: In this critical role you will lead regulatory strategies product submissions and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA) EU (MDR) China (NMPA) an More...

Responsibilities: Lead data management activities as a program-level lead data manager in support of Alnylam clinical studies. Lead database build activities including leading cross-functional review of eCRF content review of edit check specifications and perform user acceptance test More...

Responsibilities: Independently identify prioritize and lead all CDM activities for assigned study. Represent CDM function at internal/external team calls. Communicate and able to provide CDM expertise for DM related activities. Responsible for ensuring the following activities are s More...

Roles & Responsibilities: Bachelors/Masters in Statistics CS Life Sciences or related field. 8-12 years clinical programming exp. with leadership exposure. Lead programming activities across studies and clinical development phases. Oversee CRO deliverables for quality timeliness and More...

Roles & Responsibilities: Data Analytics portfolio and Pharmacy domain (key). Modernization projects. driving transitions across multiple vendors. build transition plan work w key stakeholders- END TO END project management. hands on PM- execution. 4-5 workstreams and those budgets. More...

Job Description: The primary location for this role is Wilson NC. Design is taking place in Conshohocken PA. The design phase requires a hybrid work location of remote and onsite in Wilson as well as routine travel to Conshohocken. Once the design phase is completed this role will su More...

Responsibilities: Team provides customized real-world data and real-world evidence solutions to address the most important research questions across clinical development market access and commercial use cases for our life sciences partners. Independently translate analytic specificat More...

Responsibilities: The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS) Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products including regulatory responsibilities in associated change control an More...

Job Description: Perform operations maintaining product quality and production levels. Work as a team member for maximum effectiveness. Responsibilities include product inspection operating equipment raw material/finished goods movement and cleaning /sanitizing. Monitor machine functi More...

Job Description: We are looking for a Supplier Manufacturing Engineer with a strong background in manufacturing engineering and supplier management to improve the quality and efficiency of our supply chain for data center equipment. The role involves collaborating with suppliers to en More...

Job description: The Quality Associate III plays a key role in ensuring supplier quality compliance and performance across the supply chain. The position supports both sustaining and new product initiatives by collaborating with internal teams and suppliers to establish robust qualit More...

Responsibilities: Follow all company safety rules regulations and job safety analysis. Must complete plant lock out procedures and key interrupt. Fill and operate shelf carton erector and clear minor jams. Responsible for quality of product including but not limited to. Discarding ob More...

Job Description: Expertise in tablet ointment and liquid dosage product forms used in pharma manufacturing. Provide technical assistance to manufacturing and quality operations for process troubleshooting. Ability to work in cross functional teams provide strong analytical skills fo More...

Responsibilities: Troubleshooting MATLAB compatibility issues with laptop Security/antivirus software: installation activation configuration and license management issues. Troubleshooting and resolving technical issues including those involving cloud platforms (like AWS and Azure Git More...

Responsibilities: Lead data management activities as a program-level lead data manager in support of Alnylam clinical studies. Lead database build activities including leading cross-functional review of eCRF content review of edit check specifications and perform user acceptance test More...

Responsibilities: Conduct statistical programming and analysis of clinical research studies. Provide programming support for publication efforts and regulatory submissions. Manage the timely creation review completion and delivery of statistical programming activities and deliverable More...

Responsibilities: Responsibilities include developing regulatory strategies reviewing design input/output documentation identification of applicable standards and guidance documents performing regulatory assessments to determine the impact of design/process changes preparing regulato More...

Roles & responsibilities: Our client is looking for a Lab Vantage LIMS Admin. They are utilizing version 8.6 to support and maintain their laboratory informatics systems within a regulated GMP pharmaceutical environment. The ideal candidate will manage user support and compliance act More...

Responsibilities: Collaborate at a systems level with R&D Clinical Data Analysis and other key functions to develop a quantitative approach to risk management. Lead cross-functional teams to identify risks implement risk control measures and document a robust and living Risk Manageme More...