cGxPServe

Responsibilities: Provide leadership strategic planning direction and implementation of clinical systems for data collection which may include vendor selection budgeting resource planning vendor oversight EDC build and study timelines etc. Perform or provide oversight to staff for al More...

Job Description: Client is seeking a Verification and Validation SR Engineer to help with formal verification and validation of complex medical devices under the regulations of the FDA. The individual will be part of an engineering team that is responsible for requirements based manu More...

Responsibilities: Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Creates revises and implements quality standards as well as procedures i.e. Standard Operating Procedures (SOPs) etc. for Erbe USAs Quality Management Sy More...

Responsibilities: Leads the statistical programming activities for projects with lower complexity. Leads the statistical programming activities for studies. Develop SAS programs for the creation of Adam data sets following CDISC standards. Develop SAS programs for the creation of Tab More...

Job Description: We are seeking a highly skilled Bioinformatics Data Analyst to join our team. The ideal candidate will be responsible for retrieving managing and visualizing large datasets while developing custom applications and the integration of laboratory equipment. Responsibilit More...

Responsibilities: In this role you will perform specialized level work assignments and/or analyses evaluation preparation and submission of documentation for regulatory registration ensuring products and procedures comply with regulatory agency specifications. Supports necessary regu More...

Responsibilities: Provides leadership/expertise in day-to-day statistical programming in support of ongoing projects. Develops and/or validates SAS programs to generate SDTM/ADaM datasets following industry standards regulatory requirements and statistical instructions. Develops and/ More...

Responsibilities: Collaborate with data managers statistical programmers biostatistics clinical operations and external vendors to review sign off on the data transfer specifications and transfer data from external sources ensuring data is received and validated for data integrity. C More...

Responsibilities: Regulatory Labelling Documentation. Support the creation and maintenance of assigned labeling projects to enable worldwide regulatory submissions. Independently prepare and maintain the Tracking Sheets for the global regulatory dossiers related to labeling projects More...

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 solve problems related to non-routine situation More...

Job Description: The consultant operating under general guidance will be responsible for the preparation execution review and approval of commissioning and qualification protocols reports and assessments related to equipment facilities and utilities. Additionally the role will involve More...

Responsibilities: Preparing documentation for international regulatory registrations. Preparing technical documentation to compliant to MDD and EU MDR. Defining worldwide regulatory requirements are necessary for regulatory approval of products. Participating in cross functional team More...

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 More...

Responsibilities: As a Senior Statistical Programmer you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. This role can be performed as fully remote. Performing data manipula 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...

Roles & Responsibilities: Minimum 3 years experience with SAP or Blue Yonder Warehouse Management Systems. 3 years experience with System Development Lifecycle. 3 years experience in Computer System Validation. Experience with FDA CSA principles Experience with Pharmaceutical CSV Fra More...

Responsibilities: The Senior Quality Engineer is responsible for leading and executing complex validations driving process improvement projects and ensuring alignment with procedural and regulatory requirements. This role requires strong technical expertise effective communication sk More...

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 More...

Job description: Handling the recruitment process of sourcing till joining of the candidate. Develop and update job descriptions and job specifications. Prepare and post jobs to appropriate job portals etc. Responsible for handling different types of IT/ Non-IT requirements. Assist i More...

Job Description: Here are the details of what candidates need experience with these are the keys below to getting the interview and getting hired they are wanting people that fit this exact Mold below as best as possible anyone outside of the Mold will be an uphill battle More...