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Spec I Pss
2 months ago
Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables
Ensure compliance of operations with governing regulatory requirements
Create, maintain and assume accountability for a culture of high customer service
Efficiency in conducting literature searches for authoring various types of reports
Author/review various safety reports (or part of such reports) for global regulatory submissions for Labcorp’s clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Periodic Benefit-Risk Evaluation Reports, Bridging reports and other clinical documents as assigned.
Perform/review Signal detection activities
Author/ review RMP, ad hoc reports, Safety Update reports, Benefit-Risk Evaluation, CCDS supporting document, ACOs, Addendum reports
Perform allied activities like: Generation of line listings and summary tabulation, CFIs CFCs
Search literature databases for relevant information, recommend label changes, author proposed label text and prepare supporting/justification document
Author/review SOPs/WIs/process documents or sections as applicable
Impart/conduct Trainings for peers and team members
Any additional activities as per the project requirement or manager’s discretion on completion of relevant trainings
**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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Spec I Pss
2 weeks ago
Navi Mumbai, Maharashtra, India Labcorp Full timeLabcorp Drug DevelopmentAs a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired...
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Spec I Pss
2 months ago
Navi Mumbai, India Labcorp Full timeLabcorp Drug Development As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired...
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Spec I Pss
3 weeks ago
Navi Mumbai, India Labcorp Full timeImplement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables Ensure compliance of operations with governing regulatory requirements Create, maintain and assume accountability for a culture of high...
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Spec I Pss
3 weeks ago
Navi Mumbai, India Labcorp Full timeBachelors - Life sciences 2-4 Years Efficiency in conducting literature searches for authoring various types of reports Write various safety reports (or part of such reports) for global regulatory submissions for Labcorp’s clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports,...
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Spec I Pss
3 weeks ago
Mumbai, India Fortrea - Organic Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
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Spec I PSS
2 weeks ago
Mumbai, Maharashtra, India Fortrea Full timeAs a prominent global contract research organization (CRO) with a strong focus on scientific excellence and extensive experience in clinical development, Fortrea offers pharmaceutical, biotechnology, and medical device clients a diverse array of clinical development, patient access, and technology solutions spanning over 20 therapeutic areas. With a...
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Spec I PSS
3 weeks ago
mumbai, India CSS Fortrea Scientific Pvt Ltd Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
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Spec I PSS
3 weeks ago
Mumbai, India CSS Fortrea Scientific Pvt Ltd Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
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Spec Ii Pss
3 months ago
Navi Mumbai, India Labcorp Full timeImplement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables - Ensure compliance of operations with governing regulatory requirements - Create, maintain and assume accountability for a culture of high...
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2 weeks ago
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Junior I/o Data Support
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Safety Science Coordinator I
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Spec. Regulatory Reporting
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Spec. Regulatory Reporting
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Remote Resolution Spec
3 weeks ago
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Remote Resolution Spec
2 weeks ago
Mumbai, Maharashtra, India NCR Atleos Full timeAbout NCR NCR Corporation (NYSE: NCR) is a leader in transforming, connecting and running technology platforms for self-directed banking, stores and restaurants. NCR is headquartered in Atlanta, Ga., with 38,000 employees globally. NCR is a trademark of NCR Corporation in the United States and other countries. Position Description The Remote Resolution...
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Product Sales Specialist
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Product Sales Specialist
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Pdms Administrator
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Design and Detail Engineer
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