Responsibilities: As a regulatory process expert supporting global registrations the candidate interprets federal/state/international regulations as they apply to our products, processes and procedures, advises on impact of regulations, d...
Job Description The Quality Assurance (QA) Validation Lead is responsible for the Computer System Validation (CSV) and change control processes in a GxP-regulated environment. The QA Validation Lead provides compliance guidance to InClin b...
Responsibilities and Requirements : The client has deliverables coming up and needs a consultant to help hit specific deadlines. This role is a combo device position, the consultant is required to have experience with prefilled syringes,...
Responsibilities: Support the planning, setup, and acquisition of external clinical data at the study level, assisting in managing study start-up, conduct, and closeout activities. Assist in creating external data transfer agreements, en...
Responsibilities: The client has deliverables coming up and needs a consultant to help hit specific deadlines. This role is a combo device position, the consultant is required to have experience with prefilled syringes, Class II/III devi...
Top 3 skills: Strong background in IQ, Process Characterization, OQPQ, and Test Method Development and Validation Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.) Strong understanding of medical device manufactu...
Responsibilities: Minimum of 4 years of experience in laboratory management or laboratory informatics, with a strong understanding of LIMS systems and their applications. Strong analytical and problem-solving skills, with the ability to ...
Responsibilities: Strong programming skills in SAS / R programming and data analysis. Extensive work experience with large US insurance claims databases, electronic medical records, registry databases for health outcomes research (e.g., ...
Responsibilities: Support the Global Regulatory Team (GRT) in US Regulatory Activities (e.g. IND development and submission). Act as the point of contact with regulatory agencies. Provide guidance on local mechanisms to optimize product...
Responsibilities: Provide first line monitoring support for SAP application modules, covering GMT time zone. Investigate issues with iDocs and other data transport objects throughout the GMT time zone and report and track issues to exter...
Responsibilities Ensure the lab instruments are calibrated prior to performing IQ/OQ and certify. Produce GxP documentations for the instrument software validation. Own change controls and deviation management Prepare and execute IQ/OQ...
Responsibilities: Work collaboratively with process, engineering, and production teams to assess requirements and influence the design of automation systems. Play a key role in the development and implementation of innovative automation ...
Responsibilities: Develop global or US regulatory strategy for Oncology products in development and through life cycle management, considering all relevant guidance, commercial needs, and company objectives. Develop strategic direction a...
Responsibilities: Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health and other devices to enhance the value of our pharmaceutical products across t...
Responsibilities: Utilize MODA-ES principles to design, implement, and maintain model-driven architectures for embedded systems. Develop validation scripts to test Python or similar programming. Develop Computer System Validation delive...
Roles & Responsibilities: Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health and other devices to enhance the value of our pharmaceutical products ...
Responsibilities: This project is staff support to a large client, filling in as a member for their team in-leu of their own. This program is intended to support client in their requested requirement for regulatory submissions that may h...
Roles & Responsibilities: Develop global or US regulatory strategy for Oncology products in development and through life cycle management, considering all relevant guidance, commercial needs, and company objectives. Develop strategic dir...
Responsibilities: To ensure the efficiency and quality of biometry deliverables; ensure that all clinical datasets meet the standards required for regulatory submissions for all INDs and NDAs/MAAs. Responsible for Statistical Programming...
Responsibilities: Possess hands-on experience with the Veeva Vault Quality Docs System. Develop Computer System Validation (CSV ) deliverables including Validation Plan, Validation Protocols (IQ, OQ, PQ), Validation Summary Report, Data ...