Senior Clinical Regulatory Document Specialist
1 week ago
We are seeking a highly skilled Senior Clinical Regulatory Document Specialist to join our team at ScaleneWorks. In this role, you will be responsible for driving the development of high-quality clinical regulatory documents, including protocols, clinical study reports, and NDA/MAA CTD submission documents.
Key Responsibilities:- Develop and execute complex writing assignments involving a thorough understanding of clinical trial designs and interpretation of statistically analyzed research data.
- Coordinate the process to draft, review, and approve written assignments, ensuring accuracy and compliance with global pharma company standards and global, regional, and local regulatory requirements.
- Plan and prioritize projects without supervision, managing multiple tasks and deadlines effectively.
- Collaborate with cross-functional teams to ensure delivery of high-quality clinical documents that accurately reflect associated data.
- Proven track record in writing clinical regulatory documents, including protocols, clinical study reports, investigator brochures, briefing documents, and responses to regulatory authority questions.
- PhD or relevant working experience within the life sciences space.
- Clinical regulatory writing experience in the pharmaceutical industry.
- Demonstration of leadership and ability to work in multicultural settings.
- Excellent English language skills (verbal and written).
- Working knowledge of International Committee for Harmonisation (ICH)/Good Clinical Practice (GCP).
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Regulatory Compliance Specialist
2 weeks ago
Bengaluru, Karnataka, India BAN Fortrea Clinical Development Pvt Ltd Full timeOverviewBAN Fortrea Clinical Development Pvt Ltd is a leading clinical development company seeking a highly motivated and detail-oriented Regulatory Compliance Specialist to join our team. The ideal candidate will have a strong understanding of regulatory legislation, guidance, and practice in the assigned countries.
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Global Regulatory Compliance Specialist
3 weeks ago
Bengaluru, Karnataka, India BAN Fortrea Clinical Development Pvt Ltd Full timeJob Summary:This role requires a highly motivated individual to ensure compliance with regulatory requirements in the assigned countries. The ideal candidate will have a strong understanding of ICH, RA, IRB/IEC and other applicable regulations/guidelines.Key Responsibilities:Develop awareness of regulatory legislation, guidance and practice in the assigned...
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Clinical Pharmacology Lead
3 weeks ago
Bengaluru, Karnataka, India ScaleneWorks Full timeJob SummaryWe are seeking an experienced Clinical Pharmacology Lead to join our team at ScaleneWorks. As a key member of our Medical Writing department, you will be responsible for leading the development of clinical documents and providing strategic guidance on medical writing projects.About the RoleThis is a unique opportunity to work with a talented team...
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Clinical Data Standards Specialist
2 weeks ago
Bengaluru, Karnataka, India Integra Connect Full timeAt Integra Connect, we are seeking a highly skilled Clinical Data Standards Specialist to join our team in Bangalore.The estimated salary for this position is ₹1,200,000 per annum, based on industry standards and location.The successful candidate will have the opportunity to work on groundbreaking projects involving real-world data, collaborating with an...
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Bengaluru, Karnataka, India George Clinical Full timeAn exciting opportunity has arisen within our global legal team.We are seeking a highly skilled Senior Legal Counsel to oversee and handle legal matters for all entities in the George Clinical group, and support the Group General Counsel in providing strategic legal advice (whether directly or by managing external advisers), to ensure that George Clinical is...
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Pharmaceutical Regulatory Content Specialist
2 weeks ago
Bengaluru, Karnataka, India VCLS Full timeCompensation: $120,000 - $180,000 per yearAbout VCLSVCLS is a reputable pharmaceutical company seeking an experienced Pharmaceutical Regulatory Content Specialist to join our team. Our organization is dedicated to delivering high-quality medical documents for various client projects.Job DescriptionThe primary goal of this role is to deliver accurate and...
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Clinical Pharmacovigilance Specialist
3 days ago
Bengaluru, Karnataka, India Lifelancer Full timeAbout the RoleWe are seeking a highly skilled Clinical Pharmacovigilance Specialist to join our team at Lifelancer. As a key member of our regulatory affairs team, you will play a vital role in ensuring the quality and accuracy of safety reports.The ideal candidate will have 4-5 years of experience in drug safety/development or closely related areas of...
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Clinical Data Specialist
5 days ago
Bengaluru, Karnataka, India Integra Connect Full timeCompany Overview:At Integra Connect, we are committed to delivering innovative solutions that transform the way healthcare organizations manage clinical data.We are seeking a highly skilled Clinical Data Specialist to join our team and contribute to our mission of improving patient outcomes through data-driven insights.Salary: $120,000 per annum (based on...
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Bengaluru, Karnataka, India Parexel Full timeUnlock Your Potential as a Senior Medical Content LeadParexel is seeking an experienced Senior Medical Content Lead to lead our medical writing efforts and create high-quality regulatory documents.About the Role:The successful candidate will be responsible for researching, creating, and editing documents associated with clinical research. As a project lead...
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Clinical Documentation Specialist
3 weeks ago
Bengaluru, Karnataka, India Sakra World Hospital Full timeSakra World Hospital - Clinical Documentation Specialist**Job Summary:**We are seeking a highly organized and detail-oriented Clinical Documentation Specialist to join our team. As a key member of our ward operations, you will be responsible for ensuring the accuracy and completeness of patient records.**Responsibilities:Collect and verify patient...
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Clinical Project Manager
2 days ago
Bengaluru, Karnataka, India MS CLINICAL RESEARCH Full timeMS Clinical Research is a dynamic and forward-thinking clinical research organization dedicated to conducting cutting-edge clinical trials.We are seeking a highly organized and proactive Clinical Project Manager to oversee and track the progress of multiple clinical studies at various stages.This role requires strong project management skills, attention to...
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Clinical Review Specialist
1 month ago
Bengaluru, Karnataka, India Lilly Full timePosition Overview Lilly is seeking a highly skilled Clinical Review Specialist to join our Medical Affairs team. As a Clinical Review Specialist, you will play a critical role in reviewing and approving medical content to ensure it meets the highest standards of accuracy, quality, and regulatory compliance. You will collaborate closely with...
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Global Regulatory Affairs Specialist
1 week ago
Bengaluru, Karnataka, India George Clinical Full timeAbout UsGeorge Clinical is a leading global clinical research organization founded in Asia-Pacific, driven by scientific expertise and operational excellence.We have 20+ years of experience, with 500+ people managing 39+ geographical locations throughout the Asia-Pacific region, USA, and Europe.We provide a full range of clinical trial services to...
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Senior Clinical Biostatistician
2 weeks ago
Bengaluru, Karnataka, India SITERO SOLUTIONS INDIA PRIVATE LIMITED Full timeUnlock a career in clinical data analysis with Sitero Solutions India Private Limited as a Senior Clinical Biostatistician. Our team is dedicated to delivering high-quality services and software solutions for the life sciences industry.We are seeking an experienced professional to join our Bangalore office based (hybrid model) team. As a Senior Clinical...
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Regulatory Medical Content Specialist
1 week ago
Bengaluru, Karnataka, India Indegene Full timeAbout IndegeneWe are a leading technology-led healthcare solutions provider driven by our purpose to enable healthcare organizations be future ready.Our mission is to accelerate global growth opportunities for talent that's bold, industrious and nimble. With us, you gain a unique career experience that celebrates entrepreneurship, innovation, collaboration...
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Bengaluru, Karnataka, India ScaleneWorks Full timeJob Description:We are seeking a highly skilled Clinical Regulatory Expert to join our team at ScaleneWorks. In this role, you will be responsible for executing complex writing assignments involving clinical trial designs and statistically analyzed research data.Key Responsibilities:Drive and coordinate the process to draft, review, and approve written...
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Global Legal Expert
2 weeks ago
Bengaluru, Karnataka, India George Clinical Full timeGeorge Clinical is a leading global clinical research organization driven by scientific expertise and operational excellence. With over 20 years of experience, our team manages 39+ geographical locations throughout the Asia-Pacific region, USA, and Europe, offering full-range clinical trial services to biopharmaceutical, medical device, and diagnostic...
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Senior Clinical Content Strategist
3 weeks ago
Bengaluru, Karnataka, India ScaleneWorks Full timeRole OverviewScaleneWorks is seeking a highly skilled Senior Clinical Content Strategist to join our team. This role will focus on creating high-quality, fit-for-purpose clinical documents that accurately reflect associated data and are in line with global pharma company standards and global, regional, and/or local regulatory requirements.
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Senior Clinical Data Specialist
4 weeks ago
Bengaluru, Karnataka, India Novo Nordisk Full timeAbout the RoleThe Senior Medical Reviewer will be responsible for conducting comprehensive medical reviews of clinical trial data across various therapy areas within the drug development portfolio. This role ensures the highest quality and consistency of medical data, with a strong emphasis on patient safety, protocol adherence, and compliance with Good...
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Director of Regulatory Affairs Specialist
3 weeks ago
Bengaluru, Karnataka, India Lifelancer Full time**About Lifelancer**Lifelancer is a global talent-hiring platform that connects professionals with opportunities in the life sciences, pharma, and IT industries. Our goal is to help individuals advance their careers while promoting equal opportunities for people with disabilities. **Company Overview**Lilly is a global healthcare leader headquartered in...