cGxPServe

Responsibilities: Develop targeted study-specific SDTM and Adam dataset checks Perform independent QC from raw data to Adam of primary and key secondary endpoints Deliver programming results for ad-hoc analysis requests Collaborate with data management and their programming team to e المزيد...

Responsibilities: Follow all company safety rules regulations and job safety analyss. 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. Discarding obviou المزيد...

Responsibilities: Perform 3D modelling detailing and Mechanical design of electromechanical power generation and distribution products. Should have a strong knowledge of various material properties and use fabrication methods (Sheetmetal & Machined Parts surface coatings finishes adh المزيد...

Responsibilities: Analyses defects and manage Non-Conformances (Company) and Quality Notifications (QNs). Implement effective Corrective and Preventive Actions (CAPAs). Support PFMEA assessments and design transfer activities. Monitor operations performance assist in risk assessments المزيد...

Responsibilities: Preparing documentation for international regulatory registrations. Preparing technical documentation compliant to MDD and EU MDR. Defining worldwide regulatory requirements necessary for regulatory approval of products. Participating on cross functional teams as re المزيد...

Responsibilities: Assist in the development testing and validation of Electronic Data Capture (EDC) systems and Case Report Forms (CRFs). Support database setup activities including edit check specifications and user acceptance testing (UAT). Review incoming clinical data for complet المزيد...

Responsibilities: Manages most aspects of company regulatory interface with domestic and international health authorities. Manages the development and deployment of the regulatory program that ensures aggressive product approval. Manages and may generate regulatory submission documen المزيد...

Job Description: We are seeking an experienced and motivated HEOR Strategy Associate Director to join our Parkinsons Disease team. You will lead HEOR strategy and tactics managing the planning development and execution of projects to support a priority launch asset. Utilizing real-wor المزيد...

Responsibilities: 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 المزيد...

Job Description: Quality Engineer II is responsible for ensuring that products and processes meet established quality standards and customer requirements. This role supports the development implementation and maintenance of quality systems in accordance with industry regulations and c المزيد...

Job Description: Working with the Biometrics staff the candidate will provide programming support for Phase 1 to Phase 3 studies. Providing timely support to the project team on all statistical programming matters according to the project strategy. The candidate programs SDTM/ADaM/TL المزيد...

Responsibilities: To support the Biostatistics team by carrying out programming activities of statistical programmers and overseeing external vendors (as required) and to ensure timely and accurate programming and validation activities for clinical studies and publications. Contribut المزيد...

Job Description: Medical Devices Component Development Project Management Join a highly specialized team working on cutting-edge medical device development and manufacturing excellence. Were looking for a skilled Development Engineer with deep expertise in component qualification co المزيد...

Responsibilities: Support the end-to-end clinical data management process for assigned studies from protocol review to database lock. Collaborate with cross-functional teams including clinical operations biostatistics and medical writing to define data collection and reporting needs. المزيد...

Job Description: The Design Quality Engineer I will be responsible for developing quality assurance documentation to support new product development and regulatory submissions. This role requires maintaining the quality system for the design control process by identifying and correct المزيد...

Responsibilities: Support the Senior Director in developing and executing regional regulatory strategies for QOL. initiatives within specific regions. Contribute to providing strategic oversight and leadership to the regulatory team ensuring alignment with company objectives and regi المزيد...

Responsibilities: Serve as the statistical programming lead on internal project teams and coordinate programming verification and documentation of statistical programs for use in creating analysis datasets tables listings and figures. Facilitate advanced technical expertise in conjun المزيد...

Responsibilities: Provide clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects. Efficiently plan coordinate and deliver complete high quality and reliable clinical trial data المزيد...

Job Description: Uses scientific education and analytical chemistry experience to perform simple to moderately complex laboratory testing within a good manufacturing practices laboratory to generate results. Interprets data output to determine conformance to specifications. Acts as a المزيد...

Job Description: Uses scientific education and analytical chemistry experience to perform simple to moderately complex laboratory testing within a good manufacturing practices laboratory to generate results. Interprets data output to determine conformance to specifications. Acts as a المزيد...