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Online Resumes with "Post Approval"
Human Resources Manager / Generalist
I am looking for a Human Resources role in the Minneapolis/St. Paul Area where my knowledge, skills and abilities can be utilized. Most of my experience has been in the manufacturing sector but I am open minded to look at other industries.
Tags for this Online Resume:
Human Resources, Diversity, Human Resources Generalist, Strategic, Succession, Talent Acquisition, Performance Management
Featured Profile
Pharmacovigilance/ Risk Management Specialist
To leverage my Pharmacovigilance experience and knowledge of guidelines and regulations to garner greater technical writing and scientific expertise, to contribute continuously to flourish my organization.
To acquire great leadership skills in a professional environment with a challenging position in the area of Pharmacovigilance, while being resourceful, innovative, flexible and to produce world class results.
Ideal Companies: Bristol Myers Squibb, Regeneron, Pharmacyclics, Gilead, Amgen, Johnson and Johnson, Celgene, UCB, Onyx, Novartis,
Regulatory Affairs/Quality Assurance Specialist -- 5 years experience -- New Jersey
I am a Regulatory Analyst with 5 years of professional experience in developing and implementing Quality System documentation and regulatory submissions for medical devices, pharmaceuticals and biotech products. Thorough understanding of business processes such as R&D, nonclinical, clinical, pre-approval and post-approval submissions.
Featured Profile
Global Regulatory Affairs - 14 Years of Experience- New Delhi India 110021
Seeking assignments as a Global Regulatory Affairs Professional - NCEs, GENERICS- Pharma, Biotech products, Botanicals & Medical Devices in Global Regions and/or Quality & Compliance professional across the Pharma & Medical Devices Industry. Overall Profile * With overall 15+ years industrial experience, with 14+ years in the field of Global Regulatory Affairs, Compilation & Submissions of Technical Packages for IND/CTA, ND...
Ideal Companies: BBraun Medical Pvt Ltd, New Delhi, India, Glenmark Pharmaceuticals Ltd., Mumbai, India, Panacea Biotec Ltd., New Delhi, India
Tags for this Online Resume:
Regulatory Affairs, Management, Medical Devices, Pharmaceutical Industry, IND/CTA, Formulations & APIs, Regulatory Audits & Compliances, NCEs/NMEs/Generics, CT, Regulatory Consultancy, Regulatory Due Diligence & Gap Assessment
Medical & Clinical Laboratory Technician - 4 Years of Experience - Near 98042
Summary of Qualifications Highly skilled Navy hospital corpsman and medical laboratory technician with 4 years experience in customer service and laboratory operations and a proven ability to lead and solve complex technological and logistical problems. Subject matter expert with computer systems/networks and training personnel. Directed effective communication Communication with 60 reference laboratories 100 providers at 9...
Tags for this Online Resume:
Customer Service, Management, Medical, Microbiology, Quality, Quality Assurance, Quality Control, Test, Training
Clinical Data Management - 14 Years of Experience - Near 28411
I am a Clinical Data Manager with 14 years experience in all aspects of clinical trial from early development to post approval. I am interested in using my extensive experience to join a Data Management group.
Tags for this Online Resume:
Remote, Medidata Rave, Work from hom, Clinical Research, Early Development, Phase I-IV
Chemist - 13 Years of Experience - Near 07728
To obtain a challenging position in pharmaceutical industry involved in drug discovery and quality control that takes advantage of my experience in medicinal chemistry, organic synthesis and analytical laboratory skills. Willing to make an impact for the success and growth of a cutting edge company by utilizing my skills and experience. Professional Summary: * Experienced in medicinal chemistry, organic synthesis and qualit...
Tags for this Online Resume:
Chemistry, Research, Sar
Biochemist - 18 Years of Experience - Near 21224
QUALIFICATIONS SUMMARY * cGMP quality management experience [ QA/QC and RA]. QA experience with quality management systems (QMS) and documentation, batch record reviews, annual product reviews, SOP drafting, review and approve, investigate deviation, change and document control. Established key performance indicators (KPIs), quality by design (QbD) process analytical technology (PAT) and Quality metrics. Experienced with de...
Tags for this Online Resume:
Reviews, Chemistry, CMOS, Compliance, Documentation, Drafting, Product Development, Security, Systems Development, High Performance Liquid Chromatography (HPLC), pharmaceutical
Quality Assurance Director - 11 Years of Experience - Near 07076
SUMMARY Detail oriented and results focused professional with experience working in a global pharmaceutical company, research and development with multiple manufacturing sites and regulatory authorities worldwide. Possess clinical education, drug development and strong analytical background and solid understanding of the ICH, FDA, EMA Regulatory Guidelines as well as other regulatory body's guidelines and CMC requirements t...
Tags for this Online Resume:
Good Laboratory Practices, Microsoft, Microsoft PowerPoint, Microsoft Visio, Policies and Procedures, Protocol, Quality, Quality Assurance, Research, Research and Development
Pharmacovigilance/ Risk Management Specialist
To leverage my Pharmacovigilance experience and knowledge of guidelines and regulations to garner greater technical writing and scientific expertise, to contribute continuously to flourish my organization.
To acquire great leadership skills in a professional environment with a challenging position in the area of Pharmacovigilance, while being resourceful, innovative, flexible and to produce world class results.
Ideal Companies: Bristol Myers Squibb, Regeneron, Pharmacyclics, Gilead, Amgen, Johnson and Johnson, Celgene, UCB, Onyx, Novartis,
Regulatory Affairs/Quality Assurance Specialist -- 5 years experience -- New Jersey
I am a Regulatory Analyst with 5 years of professional experience in developing and implementing Quality System documentation and regulatory submissions for medical devices, pharmaceuticals and biotech products. Thorough understanding of business processes such as R&D, nonclinical, clinical, pre-approval and post-approval submissions.
Featured Profile
Global Regulatory Affairs - 14 Years of Experience- New Delhi India 110021
Seeking assignments as a Global Regulatory Affairs Professional - NCEs, GENERICS- Pharma, Biotech products, Botanicals & Medical Devices in Global Regions and/or Quality & Compliance professional across the Pharma & Medical Devices Industry. Overall Profile * With overall 15+ years industrial experience, with 14+ years in the field of Global Regulatory Affairs, Compilation & Submissions of Technical Packages for IND/CTA, ND...
Ideal Companies: BBraun Medical Pvt Ltd, New Delhi, India, Glenmark Pharmaceuticals Ltd., Mumbai, India, Panacea Biotec Ltd., New Delhi, India
Tags for this Online Resume:
Regulatory Affairs, Management, Medical Devices, Pharmaceutical Industry, IND/CTA, Formulations & APIs, Regulatory Audits & Compliances, NCEs/NMEs/Generics, CT, Regulatory Consultancy, Regulatory Due Diligence & Gap Assessment
Medical & Clinical Laboratory Technician - 4 Years of Experience - Near 98042
Summary of Qualifications Highly skilled Navy hospital corpsman and medical laboratory technician with 4 years experience in customer service and laboratory operations and a proven ability to lead and solve complex technological and logistical problems. Subject matter expert with computer systems/networks and training personnel. Directed effective communication Communication with 60 reference laboratories 100 providers at 9...
Tags for this Online Resume:
Customer Service, Management, Medical, Microbiology, Quality, Quality Assurance, Quality Control, Test, Training
Clinical Data Management - 14 Years of Experience - Near 28411
I am a Clinical Data Manager with 14 years experience in all aspects of clinical trial from early development to post approval. I am interested in using my extensive experience to join a Data Management group.
Tags for this Online Resume:
Remote, Medidata Rave, Work from hom, Clinical Research, Early Development, Phase I-IV
Chemist - 13 Years of Experience - Near 07728
To obtain a challenging position in pharmaceutical industry involved in drug discovery and quality control that takes advantage of my experience in medicinal chemistry, organic synthesis and analytical laboratory skills. Willing to make an impact for the success and growth of a cutting edge company by utilizing my skills and experience. Professional Summary: * Experienced in medicinal chemistry, organic synthesis and qualit...
Tags for this Online Resume:
Chemistry, Research, Sar
Biochemist - 18 Years of Experience - Near 21224
QUALIFICATIONS SUMMARY * cGMP quality management experience [ QA/QC and RA]. QA experience with quality management systems (QMS) and documentation, batch record reviews, annual product reviews, SOP drafting, review and approve, investigate deviation, change and document control. Established key performance indicators (KPIs), quality by design (QbD) process analytical technology (PAT) and Quality metrics. Experienced with de...
Tags for this Online Resume:
Reviews, Chemistry, CMOS, Compliance, Documentation, Drafting, Product Development, Security, Systems Development, High Performance Liquid Chromatography (HPLC), pharmaceutical
Quality Assurance Director - 11 Years of Experience - Near 07076
SUMMARY Detail oriented and results focused professional with experience working in a global pharmaceutical company, research and development with multiple manufacturing sites and regulatory authorities worldwide. Possess clinical education, drug development and strong analytical background and solid understanding of the ICH, FDA, EMA Regulatory Guidelines as well as other regulatory body's guidelines and CMC requirements t...
Tags for this Online Resume:
Good Laboratory Practices, Microsoft, Microsoft PowerPoint, Microsoft Visio, Policies and Procedures, Protocol, Quality, Quality Assurance, Research, Research and Development
Global Regulatory Affairs - 14 Years of Experience- New Delhi India 110021
Seeking assignments as a Global Regulatory Affairs Professional - NCEs, GENERICS- Pharma, Biotech products, Botanicals & Medical Devices in Global Regions and/or Quality & Compliance professional across the Pharma & Medical Devices Industry. Overall Profile * With overall 15+ years industrial experience, with 14+ years in the field of Global Regulatory Affairs, Compilation & Submissions of Technical Packages for IND/CTA, ND...
Ideal Companies: BBraun Medical Pvt Ltd, New Delhi, India, Glenmark Pharmaceuticals Ltd., Mumbai, India, Panacea Biotec Ltd., New Delhi, India
Tags for this Online Resume: Regulatory Affairs, Management, Medical Devices, Pharmaceutical Industry, IND/CTA, Formulations & APIs, Regulatory Audits & Compliances, NCEs/NMEs/Generics, CT, Regulatory Consultancy, Regulatory Due Diligence & Gap Assessment
Medical & Clinical Laboratory Technician - 4 Years of Experience - Near 98042
Summary of Qualifications Highly skilled Navy hospital corpsman and medical laboratory technician with 4 years experience in customer service and laboratory operations and a proven ability to lead and solve complex technological and logistical problems. Subject matter expert with computer systems/networks and training personnel. Directed effective communication Communication with 60 reference laboratories 100 providers at 9...
Tags for this Online Resume: Customer Service, Management, Medical, Microbiology, Quality, Quality Assurance, Quality Control, Test, Training
Clinical Data Management - 14 Years of Experience - Near 28411
I am a Clinical Data Manager with 14 years experience in all aspects of clinical trial from early development to post approval. I am interested in using my extensive experience to join a Data Management group.
Tags for this Online Resume: Remote, Medidata Rave, Work from hom, Clinical Research, Early Development, Phase I-IV
Chemist - 13 Years of Experience - Near 07728
To obtain a challenging position in pharmaceutical industry involved in drug discovery and quality control that takes advantage of my experience in medicinal chemistry, organic synthesis and analytical laboratory skills. Willing to make an impact for the success and growth of a cutting edge company by utilizing my skills and experience. Professional Summary: * Experienced in medicinal chemistry, organic synthesis and qualit...
Tags for this Online Resume: Chemistry, Research, Sar
Biochemist - 18 Years of Experience - Near 21224
QUALIFICATIONS SUMMARY * cGMP quality management experience [ QA/QC and RA]. QA experience with quality management systems (QMS) and documentation, batch record reviews, annual product reviews, SOP drafting, review and approve, investigate deviation, change and document control. Established key performance indicators (KPIs), quality by design (QbD) process analytical technology (PAT) and Quality metrics. Experienced with de...
Tags for this Online Resume: Reviews, Chemistry, CMOS, Compliance, Documentation, Drafting, Product Development, Security, Systems Development, High Performance Liquid Chromatography (HPLC), pharmaceutical
Quality Assurance Director - 11 Years of Experience - Near 07076
SUMMARY Detail oriented and results focused professional with experience working in a global pharmaceutical company, research and development with multiple manufacturing sites and regulatory authorities worldwide. Possess clinical education, drug development and strong analytical background and solid understanding of the ICH, FDA, EMA Regulatory Guidelines as well as other regulatory body's guidelines and CMC requirements t...
Tags for this Online Resume: Good Laboratory Practices, Microsoft, Microsoft PowerPoint, Microsoft Visio, Policies and Procedures, Protocol, Quality, Quality Assurance, Research, Research and Development
