cGxPServe

Job Description: Performs a variety of chemical analyses and GMP review in accordance with cGMP GLP DEA and company policies and procedures. Responsibilities: Perform routine testing (dissolution assay/degradant content uniformity and ID) of drug products in a cGMP laboratory. Comple 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...

Responsibilities: The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance in the design manufacturing and sales of medical devices (including Class I and II devices software as a medical device). المزيد...

Responsibilities: Position leads complex studies in study design statistical analysis and interpretation of results with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to Health المزيد...

Responsibilities: Providing statistical programming support to generate tables listings and figures for assigned projects. Demonstrating proficiency in CDISC SDTM and ADaM to support various submission activities including IA CSR DSUR and publications. Overseeing all aspects of stati المزيد...

Job Description: Onsite Engineer plans leads reviews and front-ends Design Verification Sustaining Engineering and New Product Development projects as a technical contributor cum project leader and engages in all aspects of product development. Responsibilities: Leads the Design Veri المزيد...

Job Description: The Facilities Suite & Elastomer Maintenance Mechanic Level III provides support to the Engineering Services group by operating and performing daily checks on Direct and Indirect Maintenance equipment/systems and assists higher level mechanics with repairs in complian المزيد...

Roles & Responsibilities: We are now looking for a resource on the validation side of things going on here. Depending on the resource were looking for someone with (LabVantage) LIMS and quality systems validation experience and/or general more broad Pharma/Biotech CSV experience that المزيد...

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 المزيد...

Job Description: Were seeking an experienced Computer Systems Validation (CSV) professional to join our team and lead end-to-end validation activities supporting laboratory system upgrades and data integrity initiatives. This role is ideal for someone with a strong background in regu المزيد...

Job Description: The Finishing Support Associate helps with assembling kits preparing packaging materials and supporting finishing area activities. This role follows safety and quality procedures in a clean manufacturing environment. Responsibilities: Assemble kits and screen product المزيد...

Job Description: This position will play a critical role in ensuring the ethical and responsible conduct of clinical trials to protect study participants from potential harm safeguard the integrity of the trial. By identifying potential problems early the clinical data specialist can المزيد...

Job Description: Quality Engineer w/ Design Quality Engineering experience product quality support design verification & Risk Management (ISO 14971) Failure Assessment (FMEA) MUST HAVE Medical Device experience. Quality Engineer will be a part of the clients Diabetes Post-Market المزيد...

Responsibilities: Support all Data Management activities for assigned projects including outsourced and/or insourced models. May act as the Lead Data Manager or Support Data Manager on insourced studies and act as Oversight Data Management Lead or support for outsourced studies. Acti المزيد...

Responsibilities: Providing statistical programming and validation support for clinical study reports overseeing programming activities by external vendors (e.g. CROs) when necessary and coordinating programming activities among the study programmers to achieve timely progress in the المزيد...

Responsibilities: Represent Data Management in study team meetings providing metrics and guidance on data-related issues. Oversee Data Management activities from study start-up to close-out. Develop and manage study timelines and ensure the quality and timeliness of data from service المزيد...

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

Responsibilities: Provide input on key study-related documents produced by other functions (e.g. CRFs Data Management Plan SAPs etc.). Create or review and approve CDISC-compliant datasets and corresponding documentation for electronic submission to regulatory agencies. Develop softw المزيد...

Job Description: As part of the sustaining engineering team you will be responsible for design changes for medical device products such as hospital beds and equipment. The engineering design changes may be related to design improvements new compliance requirements or supply chain supp المزيد...

Job Description: This is what you will do: The Quality Events Specialist is a member of the Central Quality Systems and Compliance (CQSC) team. This position will support the execution of the Quality Management System. Responsibilities: Laboratory Investigation Record Quarterly Tr المزيد...