As a Technical Configuration and System Integration Specialist, your role involves configuring Veeva Vault modules to meet business requirements and ensuring system validation. Additionally, you will be responsible for document management and system administration, specifically focusing on Quality Docs and Electronic Document Management System (EDMS). Key Responsibilities: - Administer and maintain Veeva Vault DMS, including Quality Docs and other modules. - Configure Vault modules such as Quality Docs, QMS, RIM, Promo Mats, and eTMF. - Oversee the document lifecycle from creation to archiving in compliance with GxP and quality standards. - Maintain version control, metadata, and audit readiness. - Configure system settings for optimal performance. - Provide user support and training. - Generate compliance and performance reports. - Liaise with Veeva Support for escalations. - Manage lifecycles, workflows, permissions, and metadata. - Handle user management and environment promotions. - Support integrations with enterprise systems like SAP and Salesforce. - Author configuration specs, validation scripts, and test records. - Train users and support system releases and regression testing. In your duties and responsibilities, you will: - Administer and maintain the Veeva Vault Document Management System (DMS) to ensure document accuracy, integrity, version control, and accessibility in compliance with regulatory and quality standards. - Configure system settings to meet business requirements for optimal performance and user experience. - Provide technical and functional support to end-users, troubleshoot issues, and manage configuration change requests. - Collaborate with cross-functional teams to resolve issues related to Veeva Vault integrations with other enterprise systems. - Manage the document lifecycle from creation to archiving in compliance with company policies and GxP regulations. - Implement and enforce version control and metadata management for approved document access. - Handle escalated system issues and coordinate with vendors for major technical problems. - Develop and deliver training programs for staff on document control processes and Veeva Vault functionalities. - Generate reports on document control metrics, system performance, and compliance trends. - Configure Veeva Vault modules according to business requirements. - Support administrative tasks such as user management and environment promotion. - Collaborate with business process owners to translate requirements into Vault configurations. - Develop configuration specifications, test scripts, and validation documentation in compliance with GxP. - Assist in integrating Vault with other enterprise systems. - Provide training and support for end users and business administrators. - Participate in release management, regression testing, and change control processes. - Ensure familiarity with CSV / CSA validation and electronic records. Qualifications Required: - Bachelor's or Master's degree in Computer Science, Life Sciences, or related field. - 8+ years of experience with Veeva Vault configuration. - Strong understanding of GxP, 21 CFR Part 11, and validation requirements. - Experience in a regulated environment (QA, Regulatory, or Clinical Operations). - Proficiency in Veeva Quality Docs. Please note that this position operates in an office setting in Hyderabad, India, with limited remote work options. Additionally, you may be required to be available outside regular hours to handle priority business needs. This is a largely sedentary role with no direct reports.,
As a Quality Management System (QMS) Specialist, your role will involve establishing, implementing, and continuously improving the company's QMS to support its clinical-stage biopharmaceutical development programs while ensuring compliance with regulatory requirements such as FDA, EMA, ICH, and GxP standards like GMP, GDP, GCP, GLP. Your responsibilities will include: - **QMS Development & Implementation**: - Developing, implementing, and maintaining a phase-appropriate QMS aligned with regulatory requirements. - Establishing, reviewing, and updating Quality System documentation to support GxP operations. - Serving as the system owner for the electronic QMS and ensuring effective document control. - Monitoring QMS performance through defined KPIs and implementing continuous improvement initiatives. - **Compliance, Audits & Quality Oversight**: - Ensuring organizational compliance with internal quality standards and global regulatory expectations. - Leading internal audit programs and coordinating external audits and inspections. - Managing audit findings and CAPAs to ensure timely closure and sustained compliance. - Supporting vendor qualification and ongoing oversight of CMOs, CROs, and testing laboratories. - **Deviation, CAPA, and Change Control**: - Overseeing deviation, investigation, and CAPA systems to ensure effective root cause analysis and preventive action. - Managing change control processes for systems, procedures, and documentation. - Fostering a culture of accountability and proactive issue prevention across functions. - **Document & Training Management**: - Administering document management and training systems to maintain inspection readiness. - Ensuring training programs align with procedures, regulatory requirements, and company quality objectives. - Tracking and reporting compliance metrics, including training completion and document revision cycles. - **Inspection Readiness and Continuous Improvement**: - Supporting preparation for regulatory inspections and sponsor audits. - Conducting periodic management reviews of QMS performance and providing compliance trend analyses. - Championing continuous improvement and quality culture initiatives. **Qualifications and Experience**: - Masters or doctorate degree in Life Sciences, Pharmacy, Biotechnology, or related discipline. - 8 to 12 years of experience in Quality Assurance or Quality Systems within the biotechnology industry. - Proven track record in developing, implementing, and managing QMS within GMP-regulated environments. - Familiarity with GxP compliance requirements across clinical development and manufacturing. - Experience supporting regulatory inspections and interacting with CMOs, CROs, and regulatory authorities. Your strong command of phase-appropriate GxP and ICH Q-series guidelines, eQMS administration skills, proficiency in Veeva Vault and Regulatory Information Management Systems, and effective communication with cross-functional teams will be crucial in this role. Additionally, your analytical thinking, problem-solving, organizational skills, and deep understanding of bio-therapeutics manufacturing will contribute to operational excellence. Please note that this position operates in an office setting, in person, and may require availability outside of regular hours to handle priority business needs.,
Role Overview: As a critical member of the team, you will be responsible for driving the design, execution, and interpretation of preclinical studies to support the discovery and development of novel therapeutics for neurological disorders. Your expertise in neuroscience, pharmacology, and translational science will be instrumental in advancing drug candidates, including biologics and gene therapies, from early discovery through IND-enabling studies. Key Responsibilities: - Lead preclinical strategy and execution for neuroscience drug discovery programs. - Design and oversee in vivo and in vitro studies to evaluate pharmacodynamics, efficacy, and safety. - Guide target validation, biomarker development, and mechanism-of-action studies. - Serve as the preclinical lead on cross-functional project teams. - Collaborate with medicinal chemistry, DMPK, toxicology, and clinical teams for seamless transition from discovery to development. - Mentor and supervise a team of scientists and research associates. - Identify and manage CROs and academic partnerships for preclinical research support. - Contribute to the preparation of regulatory documents including INDs, IBs, and briefing packages. - Support IND-enabling studies and contribute to regulatory submissions. - Translate preclinical findings into clinical hypotheses and biomarker strategies. Qualifications: - Ph.D. in Neuroscience, Pharmacology, or related discipline; postdoctoral experience preferred. - 8+ years of relevant experience in preclinical drug discovery. - Proven track record in leading neuroscience programs to preclinical candidate nomination. - Expertise in neurobiology, in vivo pharmacology, and translational models of CNS disorders. - Strong leadership, communication, and project management skills. - Experience with IND-enabling studies, regulatory documentation, and biomarker discovery. - Proficiency in partnership management, publication record in high-impact journals, and hands-on experience with neurological animal models. Additional Company Details: This position operates in an office setting and requires in-person presence, with limited remote work. The job may also require availability outside regular hours for priority business needs. It is a largely sedentary role with no direct reports. Role Overview: As a critical member of the team, you will be responsible for driving the design, execution, and interpretation of preclinical studies to support the discovery and development of novel therapeutics for neurological disorders. Your expertise in neuroscience, pharmacology, and translational science will be instrumental in advancing drug candidates, including biologics and gene therapies, from early discovery through IND-enabling studies. Key Responsibilities: - Lead preclinical strategy and execution for neuroscience drug discovery programs. - Design and oversee in vivo and in vitro studies to evaluate pharmacodynamics, efficacy, and safety. - Guide target validation, biomarker development, and mechanism-of-action studies. - Serve as the preclinical lead on cross-functional project teams. - Collaborate with medicinal chemistry, DMPK, toxicology, and clinical teams for seamless transition from discovery to development. - Mentor and supervise a team of scientists and research associates. - Identify and manage CROs and academic partnerships for preclinical research support. - Contribute to the preparation of regulatory documents including INDs, IBs, and briefing packages. - Support IND-enabling studies and contribute to regulatory submissions. - Translate preclinical findings into clinical hypotheses and biomarker strategies. Qualifications: - Ph.D. in Neuroscience, Pharmacology, or related discipline; postdoctoral experience preferred. - 8+ years of relevant experience in preclinical drug discovery. - Proven track record in leading neuroscience programs to preclinical candidate nomination. - Expertise in neurobiology, in vivo pharmacology, and translational models of CNS disorders. - Strong leadership, communication, and project management skills. - Experience with IND-enabling studies, regulatory documentation, and biomarker discovery. - Proficiency in partnership management, publication record in high-impact journals, and hands-on experience with neurological animal models. Additional Company Details: This position operates in an office setting and requires in-person presence, with limited remote work. The job may also require availability outside regular hours for priority business needs. It is a largely sedentary role with no direct reports.
Role Overview: As a Technical Configuration and System Integration Specialist, your primary focus will be on configuring Veeva Vault modules to meet business requirements and ensuring system validation. You will also be responsible for administering document management and system administration tasks related to Quality Docs and Electronic Document Management System (EDMS). Key Responsibilities: - Administer and maintain Veeva Vault DMS, specifically focusing on Quality Docs or equivalent modules. - Configure various Vault modules such as Quality Docs, QMS, RIM, Promo Mats, and eTMF to align with business needs. - Oversee the document lifecycle from creation to archiving while adhering to GxP and quality standards. - Maintain version control, metadata, and ensure audit readiness within the system. - Configure system settings to optimize performance and user experience. - Provide user support and conduct training sessions. - Generate compliance and performance reports as required. - Collaborate with Veeva Support for issue escalations. - Manage lifecycles, workflows, permissions, and metadata within the system. - Assist in user management and environment promotions. - Support integrations with enterprise systems like SAP, Salesforce, etc. - Create configuration specs, validation scripts, and test records. - Train users and support system releases and regression testing. Qualifications Required: - Bachelors or masters in computer science, Life Sciences, or related field. - Minimum of 8 years of experience in Veeva Vault configuration. - Strong understanding of GxP, 21 CFR Part 11, and validation requirements. - Proficiency in document control, compliance, and GxP practices. - Previous experience in a regulated environment such as QA, Regulatory, or Clinical Operations. - Proficient in Veeva Quality Docs. Additional Company Details (if applicable): The position operates in an office setting primarily, with limited remote work options. The role may require availability outside regular hours to address priority business needs. Physical requirements for this role are largely sedentary, and there are no direct reports associated with this position.,
As a critical member of the team, your primary responsibility will be to drive the design, execution, and interpretation of preclinical studies to support the discovery and development of novel therapeutics for neurological disorders. Your deep expertise in neuroscience, pharmacology, and translational science will play a key role in advancing drug candidates, including biologics and gene therapies, from early discovery through IND-enabling studies. **Key Responsibilities:** - Lead preclinical strategy and execution for neuroscience drug discovery programs. - Design and oversee in vivo and in vitro studies to evaluate pharmacodynamics, efficacy, and safety. - Guide target validation, biomarker development, and mechanism-of-action studies. - Serve as the preclinical lead on cross-functional project teams. - Collaborate with various teams to ensure seamless transition from discovery to development. - Mentor and supervise a team of scientists and research associates. - Identify and manage CROs and academic partnerships to support preclinical research. - Contribute to the preparation of regulatory documents including INDs, IBs, and briefing packages. - Support IND-enabling studies and contribute to regulatory submissions. **Qualifications:** - Ph.D. in Neuroscience, Pharmacology, or related discipline; postdoctoral experience preferred. - 8+ years of relevant experience in preclinical drug discovery. - Proven track record in leading neuroscience programs to preclinical candidate nomination. - Expertise in neurobiology, in vivo pharmacology, and translational models of CNS disorders. - Strong leadership, communication, and project management skills. - Experience with IND-enabling studies and regulatory documentation. - Publication record in high-impact neuroscience or pharmacology journals. In addition to the above qualifications, you should have hands-on experience with various neurological animal models, in vivo neuroscience expertise, behavioral phenotyping, histological and molecular analysis, electrophysiology and imaging, cell-based assays, drug testing, and gene therapy product testing. Your proficiency in data analysis, statistical operations, and knowledge in areas such as neuroimmunology, synaptic biology, and neurodevelopmental disorders will be invaluable in this role. Please note that this position operates in an office setting, with limited remote work availability. Your dedication and expertise will contribute significantly to the advancement of preclinical research in the field of neurological disorders.,