Regulatory Documentation Specialist CLIN BIOSCIENCES

1.0 - 5.0 years

0 - 0 Lacs

bangalore, chennai, hyderabad

On-site

Roles and Responsibilities Prepare, edit, format, and manage regulatory documents including: Clinical study protocols & reports Investigator brochures Common Technical Documents Modules 25 Risk Management Plans Briefing documents and response packages. Work closely with regulatory affairs, clinical, safety, medical writing, and quality assurance teams. Maintain version control and document tracking using electronic document management systems. Review, QC, and validate documents to ensure scientific accuracy and editorial consistency. Required Skills: Excellent written communication and technical documentation skills. Knowledge of regulatory submission processes and eCTD structure. Familiarit...

Posted 3 months ago

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External Affairs Analyst- Healthcare CLIN BIOSCIENCES

2.0 - 5.0 years

0 - 0 Lacs

mumbai city, united arab emirates, qatar

On-site

We are seeking a strategic and detail-oriented External Affairs Analyst-Healthcare to support our organizations engagement with external stakeholders including government bodies, regulatory authorities, healthcare policymakers, and industry associations. Roles and Responsibilities Track and analyze healthcare legislation, government policy updates, and regulatory changes. Assist in shaping and delivering the organizations external engagement strategy. Draft policy briefs, position statements, and regulatory impact assessments. Liaise with government officials, public health bodies, and industry associations. Provide strategic recommendations on healthcare policies affecting business operatio...

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Digital Clinical Trial Designer CLIN BIOSCIENCES

2.0 - 5.0 years

0 - 0 Lacs

bangalore, hyderabad, pune

On-site

Roles & Responsibilities: Design digital-first clinical trials (decentralized, hybrid, or virtual trials) aligned with therapeutic and regulatory goals. Apply AI/ML techniques to improve patient recruitment strategies, site selection, and protocol optimization. Collaborate with clinical and data science teams to build adaptive trial designs and data-driven decision workflows. Integrate real-world data (RWD), EHRs, and wearables/remote sensors into trial protocols. Coordinate with software engineering teams to develop or customize digital platforms for eConsent, ePRO, and telemedicine. Implement real-time data visualization, anomaly detection, and risk-based monitoring strategies. Qualificati...

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Clinical Informatics Specialist CLIN BIOSCIENCES

0.0 - 3.0 years

0 - 0 Lacs

bangalore, hyderabad, pune

On-site

Roles & Responsibilities: Analyze clinical processes and identify areas for IT enhancement (e.g., data capture, documentation, workflow automation) Collaborate with clinicians, IT teams, and administrators to design and implement health information systems Support and maintain EHR/EMR platforms (e.g., Epic, Cerner, Meditech) Develop clinical dashboards and visualizations using tools like Power BI, Tableau, or QlikView Assist in the integration of clinical data from labs, devices, and third-party applications Ensure compliance with regulatory standards like HIPAA, NABH, HL7, FHIR Train healthcare staff on informatics systems and troubleshoot user issues Participate in data quality assurance a...

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Regulatory Technology Analyst CLIN BIOSCIENCES

1.0 - 5.0 years

0 - 0 Lacs

hyderabad, united arab emirates, mumbai city

On-site

Roles and Responsibilities Implement and manage Regulatory Information Management Systems and eCTD platforms Automate regulatory submission workflows, ensuring compliance. Work with regulatory affairs teams to manage submission timelines and document lifecycle Configure and support Veeva Vault RIM, Liquent Insight, EXTEDO, or other regulatory platforms Extract, validate, and analyze structured data from submissions and global regulatory databases Assist in audit readiness, quality assurance, and compliance tracking Coordinate with IT and compliance teams for system upgrades, validations, and user training Monitor global regulatory changes and ensure systems are aligned to evolving requiremen...

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