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SAP SSAM (Service and Asset Management) Consultant | Hybrid | C2C

Trebecon LLC

•

Jersey City, New Jersey, USA

Contract

Role: SAP SSAM Consultant Location: NJ- Hybrid Key Responsibilities:Lead and support the design, configuration, and implementation of SAP SSAM solutions in alignment with industry best practices.Engage in full lifecycle SAP SSAM projects including requirements gathering, blueprinting, functional specs, testing, training, and go-live.Collaborate with business teams in the life sciences/pharma/medical device sector to understand operational and compliance requirements.Configure integration betwe
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Posted 22 hours ago

Clinical SAS Programmer

Katalyst Healthcares and Lifesciences

•

Newark, New Jersey, USA

Full-time

Responsibilities: Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s). Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets. Creates and validates tables, figures and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements. Provides input in the design and development of case report forms and clinical databases.
Posted 4 days ago | Updated 3 hours ago

Statistical Programmer

Georgia IT

•

Remote

Contract

Job Title: Statistical Programmer Location: Remote Key Responsibilities Develop, validate, and maintain SAS programs for statistical analysis, regulatory submission, and reporting deliverables. Create analysis datasets (ADaM) and tables, listings, and figures (TLFs) for clinical trial data analysis. Collaborate with statisticians and data managers to define specifications for datasets and statistical outputs. Ensure compliance with CDISC standards, internal SOPs, and regulatory guidelines (FDA,
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Posted 5 days ago

Documentation Specialist

LanceSoft Inc.

•

Athens, Georgia, USA

Contract

Job Title: Documentation Specialist Location : Athens GA 30601 Duration : 12 months Duties: Tech-savvy information management specialist to support GI Development sites / activities.Major activities include: the subject matter expert for electronic document management systems and migration of records from legacy systems.Electronic Document Management (controlled documents, regulatory submission documents): Create and configure document templates and support site users in workflow configuration.
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Posted 13 days ago

Engineer Disposables and Sustaining

Katalyst Healthcares and Lifesciences

•

Plymouth, Minnesota, USA

Full-time

Responsibilities: Create new 3rd party supplier documentation including design specifications, labelling, design drawings, etc. for peritoneal dialysis disposable sets. Create, modify, and maintain design history files. Perform change control assessments. Work closely with project manager and technical lead to achieve project commitments. Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance. Requirements:
Posted 13 days ago | Updated 3 hours ago

Clinical SAS Programmer

Katalyst Healthcares and Lifesciences

•

Boulder, Colorado, USA

Full-time

Responsibilities: Effectively manage and oversee statistical programming resources including contractors and CROs related to statistical programming deliverables to ensure high-quality within timeline and budget. Conduct hands-on validation/QC of CRO deliverables to ensure high-quality (SDTMs, ADaMs, TFLs) and ensure accuracy of clinical trial results for internal and external audiences. Ensure all relevant deliverables including investigator brochures, publications, all regulatory submission
Posted 3 hours ago

System Validation Engineer

Katalyst Healthcares and Lifesciences

•

Santa Clara, California, USA

Full-time

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabi
Posted 13 days ago | Updated 3 hours ago

Regulatory Studio CMS Senior Manager

Sureminds Solutions

•

New Brunswick, New Jersey, USA

Contract, Third Party

Job Title: Regulatory Studio CMS Senior Manager Location: New Brunswick, NJ/ Lawrenceville, NJ (Onsite) Duration : 11 Months Interview Mode : Video Job Description : Top 3 to 5 skills/Must Haves: Small Molecule Drug development experience (2 to 3 years)Good communications skills (written/verbal)Experience with Veeva System PREREQUISITES BS/BA degree in Scientific Discipline (master's or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory exper
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Posted 2 days ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

North Haven, Connecticut, USA

Full-time

Responsibilities: As a Validation Engineer within the Mold & Capital Tooling Organization, you'll play a pivotal role on a global enterprise team, collaborating with various sites around the world. In this role, you'll facilitate or perform critical validation & qualification activities, ensuring the seamless release of high-quality injection molded components that drive our mission forward. Ensure proper qualification and validation of suppliers and their processes, ensuring supplier meets th
Posted 2 days ago | Updated 3 hours ago

Senior Post Market Engineer

Katalyst Healthcares and Lifesciences

•

Gainesville, Florida, USA

Full-time

Roles & Responsibilities: Bachelor's Degree in an Engineering discipline from an accredited institution required. Complaint product analysis and testing per procedures and requirements. Root cause analysis and supports conclusions with objective evidence and sound rationale. Complaint risk analysis and complaint history reviews. Knows and applies Quality System requirements and any appropriate FDA and international standards. Must have an understanding of root cause and risk analysis as wel
Posted 60+ days ago | Updated 3 hours ago

Medical Device Engineer

Katalyst Healthcares and Lifesciences

•

North Chicago, Illinois, USA

Full-time

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabi
Posted 14 days ago | Updated 3 hours ago

Regulatory CMS Senior Manager

Sureminds Solutions

•

Remote

Contract, Third Party

C2C Role Please share Profiles at Hi, Urgent need, Job Title: Regulatory Studio CMS Senior Manager Work location: New Brunswick (preferred), Lawrenceville Monday thru Friday - Normal business hours, with some flexibility 50% onsite - Team is onsite Monday thru Thursday Top 3 to 5 skills/Must Haves: Small Molecule Drug development experience (2 to 3 years) Good communications skills (written/verbal) Experience with Veeva System PREREQUISITES BS/BA degree in Scientific Discipline (master's or hig
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Posted 2 days ago | Updated 1 day ago

Senior Biostatistician: Pharma experience / Remote

Biogensys

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Remote

Contract

Biogensys is currently hiring Senior Biostatistician with Pharma experience for 6 to 12 months contract on w2. This is a remote position, no corp to corp, or 1099. No sponsorship is available. Senior Biostatistician: Pharma experience / Remote- At least 9-10 years of experienceLead statistical aspects of clinical studies from design to final reportingReview and approve programming deliverables (ADaM datasets, tables, listings, and figures)Proven expertise in SAS and/or R for statistical analysis
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Posted 8 days ago

Clinical SAS Programmer

Katalyst Healthcares and Lifesciences

•

Minneapolis, Minnesota, USA

Full-time

Responsibilities: Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s). Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets. Creates and validates tables, figures, and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements. Provides input in the design and development of case report forms and clinical databases.
Posted 7 days ago | Updated 3 hours ago

Medical Device & Regulations Engineer

Katalyst Healthcares and Lifesciences

•

Santa Clara, California, USA

Full-time

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabil
Posted 18 days ago | Updated 3 hours ago

Senior Validation Engineer

Katalyst Healthcares and Lifesciences

•

Lexington, Massachusetts, USA

Full-time

Responsibilities: Shire Human Genetic Therapies Inc. is seeking a Senior Validation Engineer with the following duties: Write Validation documents per Food Drug Administration (FDA)/Company guidelines; draft Specification documents and Validation Plans (VPs) for pharmaceutical manufacturing and laboratory equipment; Write and execute qualification protocols for new equipment and decommissioning protocols for old equipment. Execute approved protocols per company Good Documentation Practices (cG
Posted 13 days ago | Updated 3 hours ago

Validation Engineer/CSV Engineer

Katalyst Healthcares and Lifesciences

•

Walnut Creek, California, USA

Full-time

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabi
Posted 3 hours ago

MES Engineer with Werum PAS-X

PDDN Inc

•

New York, New York, USA

Contract, Third Party

Role: MES Engineer Location: New York, NY / Raritan, NJ Interview: Phone/Skype Job Type: Contract JOB DESCRIPTION: PAS-X Senior Engineer Position Overview: As a Senior MES PAS-X MBR Modeler you will play a critical role in the design, implementation, and maintenance of our MBR using Werum PAS-X V2/V3. You will ensure compliance with industry standards and regulations while optimizing production processes. Key Responsibilities: Development\Modification\Upgrade\Enhancement of MBR s and GMBR
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Posted 5 days ago | Updated moments ago

Senior Outcomes Specialist

E-Solutions, Inc.

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California, USA

Third Party

Job title: Senior Outcomes Specialist Location: Remote Mandatory Skills: SQL, SAS, R, or Python, Healthcare What's in it for you :- We are seeking a results-driven and analytical Senior Outcomes Specialist to support the Foundational Data Analytics (FDA) Program. This role will focus on measuring, analyzing, and improving clinical, operational, and financial outcomes across the enterprise. The ideal candidate will bring deep expertise in healthcare analytics, outcomes measurement, and perfor
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Posted 2 days ago | Updated 17 hours ago

Clinical SAS Programmer

Katalyst Healthcares and Lifesciences

•

Princeton, New Jersey, USA

Full-time

Responsibilities: Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s). Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets. Creates and validates tables, figures and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements. Provides input in the design and development of case report forms and clinical databases.
Posted 19 days ago | Updated 3 hours ago