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. Familiarity with global regulatory guidelines. Proficiency in MS Word, Adobe Acrobat, and document templates. High attention to detail and quality-focused approach. Strong organizational and time-management skills . Interested to apply can share CV or call/WhatsApp to 9342735755

Posted 6 days 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 operations. Monitor media and public sentiment related to health policy or regulatory developments. Prepare reports, dashboards, and communications for internal stakeholders and leadership. Support advocacy and CSR initiatives in alignment with organizational goals. Qualifications Bachelors or Masters in Public Health, Pharmacy, Life Sciences, Political Science, Public Policy, or related field. 2+ years of experience in external affairs, public policy, regulatory affairs, or healthcare consulting. Strong understanding of healthcare policy landscape, government affairs, and compliance frameworks. Excellent communication, stakeholder management, and analytical skills. Experience working with ministries of health, pharma regulatory bodies, or healthcare lobby groups is preferred. Interested to apply can share CV or call/WhatsApp to 9384592766

Posted 1 week ago

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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. Qualifications: B.Pharm / M.Pharm / M.Sc / MBBS / BDS / M.Tech in Life Sciences, Public Health, or equivalent. Familiarity with healthcare IT tools and standards Interested to apply can share CV or call/whatsapp to 9384592766

Posted 1 week ago

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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 and audits related to clinical documentation Qualifications: Bachelors or Masters in Life Sciences, Pharmacy, Nursing, MBBS, or Health Informatics / Health IT Experience in hospital systems, EHR implementation, or clinical workflow design Familiarity with healthcare IT tools and standards Interested to apply can share CV or call/whatsapp to 9384592766

Posted 1 week ago

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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 requirements Qualifications Bachelor's or Masters in Life Sciences, Pharmacy, Biotechnology, Computer Science, or related discipline Experience with regulatory affairs workflows and technology tools. Certifications in regulatory affairs (RAC), Veeva Vault, or similar are a plus. Excellent communication and interpersonal skills. Ability to work independently and as part of a team. Interested to apply can share CV or call/WhatsApp to 9384592766

Posted 1 week ago

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