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: 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: 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: 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: 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: Act as the point of contact for DM activities for the assigned clinical studies and proactively provide DM expertise to both internal and CRO cross-functional teams. Assist the head of data management in establishing st...
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 ...
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...
Responsibilities: Experience working in various disease areas. They also must have specific expertise in SDTM programming, have submissions experience, and MUST possess strong skill in graphs. They need to be comfortable working as a st...
Responsibilities: SAS Programming: You'll utilize advanced SAS programming skills to analyse and report clinical trial data (both safety and efficacy). CDISC Standards: Proficiency in CDISC standards (SDTM & ADaM) is essential. You'll ge...
Responsibilities: Ensure control of systems, processes and products through facilitation of CCRB. Represent site and provide impact assessment for global changes at Global CCRB Monitor and track external audit/inspection commitments to ...
Responsibilities: Provide hands-on Statistical Programming expertise for client's early phase translation medicine group. Responsible for creating ADaM safety datasets such as ADSL, ADLB, ADVS, ADEX, ADPC (concentration), ADPP (parameter...
Responsibilities: Review and apply data mappings for customer specific data exports. Perform peer review / QC of data export programming. Produce data transfers via data export files and/or web services. Work with customers to speci...
Responsibilities: Customer facing (Weekly Service review meeting, Coe, Business meeting), Support AH Labware web application, Incident, change, problem management, Bug fixes, minor enhancements. Analyse and document customer requirements...
Responsibilities: The Senior Specialist is responsible for supporting the Quality Engineering group from a Subject Matter Expert (SME) standpoint in accordance with Client policies, standards, procedures, and Global cGMP. Functional resp...
Responsibilities: Ensure control of systems, processes and products through facilitation of CCRB. Represent site and provide impact assessment for global changes at Global CCRB. Monitor and track external audit/inspection commitments to...
Responsibilities: Provide hands-on Statistical Programming expertise for client's early phase translation medicine group. Responsible for creating Adam safety datasets such as ADSL, ADLB, ADVS, ADEX, ADPC (concentration), ADPP (parameter...
Responsibilities: Act as SME for team members in resolving any technical and operational issues. Good understanding of the domain and related processes. Independently interact with client and handle/address any queries from client. Pro...
Responsibilities: Looking for an experienced senior lawyer with current corporate in-house experience. Has experience working in a pharmaceutical corporate environment. Has good experience with regulatory, distribution, supply, commerci...
Responsibilities: Manage all data management activities according to quality standards and regulatory requirements, ensuring adherence to project timelines and budget. Oversee the development of CRFs and CCGs with other functional area r...