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Pharma Technology Transfer Specialist

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Chennai

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2 d

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Heltid

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Sjukvård

Minimum

$?700,000 Per år

Maximal

$?1,700,000 Per år

Manages technology transfer of pharmaceutical products from R&D to manufacturing. Prepares technology transfer plans, protocols, and master batch records. Coordinates transfer of analytical methods between sending and receiving units. Executes and documents process validation campaigns at receiving sites. Resolves technical issues arising during scale-up and transfer activities. Prepares comparative batch analysis and assessment reports. Coordinates with regulatory affairs for post-transfer filing requirements. Manages relationships with CMOs during third-party technology transfers. Ensures all GMP documentation is in place before commercial manufacturing. Conducts risk assessments for technology transfer activities and key decisions. Trains manufacturing teams on new product processes and control points. Prepares technology transfer completion reports and lessons learned. Stays updated with ICH Q10, Q12, and WHO technology transfer guidelines.

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Plant Head Pharma

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Chennai

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2 d

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Heltid

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Sjukvård

Minimum

$?3,000,000 Per år

Maximal

$?6,000,000 Per år

Provides overall leadership and accountability for all plant operations. Ensures manufacturing, quality, and EHS compliance at the plant site. Develops plant operating plans aligned with corporate business objectives. Manages P&L, capital expenditure, and operational cost budgets for the plant. Leads regulatory inspections including US-FDA, EU-GMP, and WHO audits. Drives continuous improvement, operational excellence, and lean initiatives. Manages relationships with corporate teams, customers, and regulatory authorities. Oversees talent management, succession planning, and leadership development. Drives technology upgrades, capacity expansions, and new product introductions. Ensures environmental compliance and occupational health and safety standards. Reviews and approves critical quality and operational decisions for the plant. Prepares annual plant performance reviews and presents to senior management. Stays current with industry benchmarks, regulatory changes, and pharma manufacturing trends.

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Nursing Superintendent

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Delhi

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2 d

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Heltid

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Sjukvård

Minimum

$?700,000 Per år

Maximal

$?2,000,000 Per år

Leads and manages all nursing operations across the hospital. Develops nursing policies, standards, and quality care frameworks. Manages recruitment, deployment, and performance of nursing staff. Oversees nursing education and continuing professional development. Monitors patient safety incidents and implements corrective actions. Ensures compliance with nursing regulatory and accreditation standards. Collaborates with medical and administrative leadership on care quality. Manages nursing budget, roster planning, and skill mix requirements. Conducts nursing audits and implements quality improvement projects. Participates in hospital infection control and patient safety committees. Handles grievances, disciplinary matters, and staff welfare concerns. Develops succession planning for senior nursing positions. Represents nursing at hospital leadership and board meetings.

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Sr. Engagement Manager - Medical Affairs Consulting

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Delhi, Mumbai

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2 d

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Heltid

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Sjukvård

Minimum

$?4,00,000 Per år

Maximal

$?12,00,000 Per år

Position: Sr. Engagement Manager - Medical Affairs Consulting Our organisation is looking for an ambitious Sr. Engagement Manager - Medical Affairs Consulting committed to quality outcomes and sustained growth. This position offers the opportunity to work with a diverse, cross-functional team in a results-oriented culture. Primary Duties and Responsibilities: ? Review source data and ensure completeness, accuracy, and regulatory compliance. ? Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. ? Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. ? Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. ? Provide clinical site training on data collection standards and regulatory requirements. ? Develop SOPs, work instructions, and training materials for clinical operations teams. ? Conduct benefit-risk assessments and contribute to clinical development strategy discussions. ? Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Required Qualifications: ? Commitment to ongoing professional learning and industry knowledge enhancement. ? Detail-oriented mindset with the ability to synthesise and present complex information clearly. ? Bachelor's degree in a relevant discipline; master's degree or professional certification is preferred. ? Proficiency in relevant software and digital tools specific to the functional area. ? Strong interpersonal and stakeholder management skills with a client-service orientation. ? At least 2?4 years of hands-on experience in a comparable professional setting. ? Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. Candidates who meet the above requirements are encouraged to submit their detailed CV at the earliest opportunity.

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Clinical Data Management - Principal Trial Manager

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Mumbai, Hyderabad

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2 d

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Heltid

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Sjukvård

Minimum

$?5,00,000 Per år

Maximal

$?18,00,000 Per år

Position: Clinical Data Management - Principal Trial Manager We invite a proactive and capable Clinical Data Management - Principal Trial Manager to lead and execute within a collaborative, agile environment. The organisation fosters a culture of continuous learning, development, and shared organisational accountability. Duties and Accountabilities: ? Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. ? Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. ? Ensure all cases are coded and processed per MedDRA and applicable global standards. ? Conduct structured literature reviews and contribute to scientific summaries and labelling. ? Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. ? Support collection and review of adverse event safety data from clinical and post-market sources. ? Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. ? Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Key Skills and Qualifications: ? Advanced competency in analytical tools, reporting platforms, and role-specific technology. ? Commitment to professional ethics, confidentiality, and the highest standards of conduct. ? Leadership experience with a track record of guiding teams, projects, or cross-functional initiatives. ? Recognised qualification in the relevant professional field at the undergraduate or graduate level. ? Sound understanding of organisational dynamics and stakeholder management in complex environments. ? Effective presentation skills with the ability to communicate complex ideas with clarity. ? Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. Successful candidates will receive access to ongoing professional development and industry-leading resources.

Handla om

We are a global provider of consulting, and outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients ? reducing time to market, reducing cost and increasing quality ? and our global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world?s leading Contract Research Organisations through a number of high-profile industry awards.