Pharmaceutical Jobs
(bio)pharma engineer start up support
Category: Pharmaceutical
Location: San Francisco, California
Engineering Start-Up Support Job Description: The incumbent will be responsible to: Support site acceptance testing of purification skids. Provide support for fermentation equipment procurement and start-up. Troubleshoot the process equipment. Generate Standard Operating Procedures for new equipment. Coordinate with site engineers and C&Q contractors to complete site acceptance testing and qualification of new purification and fermentation equipment. Maintain clear, detailed records of site acceptance testing and change control activities. The incumbent will be accountable to:Complete assigned [...]
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Location: San Francisco, California
Engineering Start-Up Support Job Description: The incumbent will be responsible to: Support site acceptance testing of purification skids. Provide support for fermentation equipment procurement and start-up. Troubleshoot the process equipment. Generate Standard Operating Procedures for new equipment. Coordinate with site engineers and C&Q contractors to complete site acceptance testing and qualification of new purification and fermentation equipment. Maintain clear, detailed records of site acceptance testing and change control activities. The incumbent will be accountable to:Complete assigned [...]
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(bio)pharma Commissioning & Qualification Support
Category: Pharmaceutical
Location: San Francisco, California
Commissioning & Qualification Support Job Description: The incumbent will be responsible for: Determine the qualification requirements for processes, systems, and equipment as necessary. Review, develop and modify test functions. Determine equipment and manpower requirements to meet the schedule. Perform an initial internal review of all protocols & reports prior to routing to stakeholders for review/ approval. Determine and manage all qualification and commissioning activities to meet timeline. Review schedule detail, perform impact analysis and risk mitigation to meet timeline. [...]
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Location: San Francisco, California
Commissioning & Qualification Support Job Description: The incumbent will be responsible for: Determine the qualification requirements for processes, systems, and equipment as necessary. Review, develop and modify test functions. Determine equipment and manpower requirements to meet the schedule. Perform an initial internal review of all protocols & reports prior to routing to stakeholders for review/ approval. Determine and manage all qualification and commissioning activities to meet timeline. Review schedule detail, perform impact analysis and risk mitigation to meet timeline. [...]
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Quality Assurance Officer
Category: Pharmaceutical
Location: Omaha, Nebraska
1. Act as expert for all compliance/Quality/QA issues and give guidance and support to R&D and future manufacturing process. 2.Assist President in developing Quality as a core value in the organization. 3. Develop, implement, direct and drive quality & process audits, document compliance, new product introduction system, process control systems, inspection & testing, corrective action systems, organizational quality information/measurement indices, the supplier management system, raw material and product specification systems, and statistical applications. 4. Responsible for all validation [...]
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Location: Omaha, Nebraska
1. Act as expert for all compliance/Quality/QA issues and give guidance and support to R&D and future manufacturing process. 2.Assist President in developing Quality as a core value in the organization. 3. Develop, implement, direct and drive quality & process audits, document compliance, new product introduction system, process control systems, inspection & testing, corrective action systems, organizational quality information/measurement indices, the supplier management system, raw material and product specification systems, and statistical applications. 4. Responsible for all validation [...]
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Clinical Applications Analyst
Category: Pharmaceutical
Location: Seattle, Washington
Seeking a Clinical Applications Analyst with solid CareNet, PharmNet, or Core and good "build" experience along with training, workflow, and testing skills. Must also have a Bachelor's Degree and 5+ years of experience in Health Care IT and clinical foundation to be considered. SKILLS: Organizational Skills Communication (Verbal/Written) Skills Analytical Skills Troubleshooting Skills Time Management Personnel Management Project Management Process Design CERTIFICATION: Clinical Certification (or Equivalent Experience)
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Location: Seattle, Washington
Seeking a Clinical Applications Analyst with solid CareNet, PharmNet, or Core and good "build" experience along with training, workflow, and testing skills. Must also have a Bachelor's Degree and 5+ years of experience in Health Care IT and clinical foundation to be considered. SKILLS: Organizational Skills Communication (Verbal/Written) Skills Analytical Skills Troubleshooting Skills Time Management Personnel Management Project Management Process Design CERTIFICATION: Clinical Certification (or Equivalent Experience)
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Vice President Drug Safety and Pharmacovigilance
Category: Pharmaceutical
Location: Raleigh/Durham/RTP, North Carolina
Vice President Drug Safety and Pharmacovigilance You will be responsible for departmental oversight of the monitoring safety profiles and providing clinical assessment of a portfolio of investigational and marketed drugs according to FDA regulations, ICH guidelines and corporate policies. The role includes detection and evaluation of safety signals. All activities will be performed in close collaboration with Clinical Operations and Regulatory Affairs and using best quality and pharmacovigilance practices. This position includes the management of other professionals in the department. [...]
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Location: Raleigh/Durham/RTP, North Carolina
Vice President Drug Safety and Pharmacovigilance You will be responsible for departmental oversight of the monitoring safety profiles and providing clinical assessment of a portfolio of investigational and marketed drugs according to FDA regulations, ICH guidelines and corporate policies. The role includes detection and evaluation of safety signals. All activities will be performed in close collaboration with Clinical Operations and Regulatory Affairs and using best quality and pharmacovigilance practices. This position includes the management of other professionals in the department. [...]
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Clinical Trial Manager (Oncology)
Category: Pharmaceutical
Location: Central, New Jersey
Clinical Trial Manager (Oncology)Princeton, New Jersey Author clinical protocols, amendments and related documents; contribute to the medical/scientific input given for the development of trial-related documents and processes. Lead the clinical trial data ongoing medical/scientific review. Prepare and run dose escalation meetings with investigators. Coordinate the real time availability of quality clinical trial data, including safety, efficacy, to provide consolidated information for dose escalation meetings. Forecast trial resources needs Develop, manage and track trial budget Develop [...]
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Location: Central, New Jersey
Clinical Trial Manager (Oncology)Princeton, New Jersey Author clinical protocols, amendments and related documents; contribute to the medical/scientific input given for the development of trial-related documents and processes. Lead the clinical trial data ongoing medical/scientific review. Prepare and run dose escalation meetings with investigators. Coordinate the real time availability of quality clinical trial data, including safety, efficacy, to provide consolidated information for dose escalation meetings. Forecast trial resources needs Develop, manage and track trial budget Develop [...]
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Lead Medical Writer
Category: Pharmaceutical
Location: Central, New Jersey
Lead Medical WriterPrinceton, New Jersey Participates as a member of clinical teams and serves as team specialist in matters pertaining to clinical documentation. The medical writer leads the documentation process and ensures compliance to FDA reporting requirements. This position is an individual contributor Prepares, edits and reviews clinical documents with guidance from Clinical Research, Biostatistics, Regulatory Affairs and Drug Safety Prepares templates and documents for pre-IND/IND/NDA/BLA applications according to requirements and regulations Assists in the preparation of [...]
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Location: Central, New Jersey
Lead Medical WriterPrinceton, New Jersey Participates as a member of clinical teams and serves as team specialist in matters pertaining to clinical documentation. The medical writer leads the documentation process and ensures compliance to FDA reporting requirements. This position is an individual contributor Prepares, edits and reviews clinical documents with guidance from Clinical Research, Biostatistics, Regulatory Affairs and Drug Safety Prepares templates and documents for pre-IND/IND/NDA/BLA applications according to requirements and regulations Assists in the preparation of [...]
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Editor - Online B2B Pharmaceutical Publications
Category: Pharmaceutical
Location: Westchester, New York
Company Our client a pure online publisher, market leader in business and scientific news dedicated to the Food, Cosmetics and Pharmaceutical industries. They are young, vibrant and multicultural, and thrive to excel in all areas of digital publishing.Their news reaches over 1,100,000 executives across 125 different countries, with more than 115,000 unique monthly visitors Job Description Our client is seeking and Editor for their Online B2B Pharmaceutical Publications to write compellingly online about the pharmaceutical industry, and to develop their pharmaceutical brands with a key focus on [...]
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Location: Westchester, New York
Company Our client a pure online publisher, market leader in business and scientific news dedicated to the Food, Cosmetics and Pharmaceutical industries. They are young, vibrant and multicultural, and thrive to excel in all areas of digital publishing.Their news reaches over 1,100,000 executives across 125 different countries, with more than 115,000 unique monthly visitors Job Description Our client is seeking and Editor for their Online B2B Pharmaceutical Publications to write compellingly online about the pharmaceutical industry, and to develop their pharmaceutical brands with a key focus on [...]
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Medical Writer, Pharmaceutical Research
Category: Pharmaceutical
Location: Overland Park, Kansas
Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to...
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Location: Overland Park, Kansas
Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to...
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Pharmaceutical District Sales Manager NDQQDM
Category: Pharmaceutical
Location: Eastern, North Dakota
Our client, a primary care pharmaceutical company, is seeking a District Sales Manager in Fargo, North Dakota and the surrounding areas.Two or more years of Pharmaceutical District Sales Management experience is required along with a documented track record of success. Experience managing a team selling to physician offices, specialists and clinics is preferred. This individual will lead and direct a sales team towards top performance. Kindly forward your resume for consideration for this outstanding sales management opportunity!Thank you in advance for your responseWe support diversity and [...]
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Location: Eastern, North Dakota
Our client, a primary care pharmaceutical company, is seeking a District Sales Manager in Fargo, North Dakota and the surrounding areas.Two or more years of Pharmaceutical District Sales Management experience is required along with a documented track record of success. Experience managing a team selling to physician offices, specialists and clinics is preferred. This individual will lead and direct a sales team towards top performance. Kindly forward your resume for consideration for this outstanding sales management opportunity!Thank you in advance for your responseWe support diversity and [...]
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