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- OH
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This function is responsible for managing workflow within and outside of External Commercial QA. This function resolves and supports the daily manufacturing and facility operations of the External Operations Team (Supply Chain, EH&S, Technical Operations, etc.) and company Contract Manufacturers (CM). This function develops and implements tactical initiatives directed by Senior Management. This function communicates events to Management and thresholds events when they are outside of the....


The holder of this position is charged with leading effort to prove control of the critical aspects of company operations, whether these relate to process, cleaning, equipment, utilities, computers or other elements. Specific emphasis will be placed on Process and Cleaning Validation.Subject matter expert in at least two main area of validation ( Process/Cleaning/Equipment /Utilities /Facilities/Computer Systems)Lead and structure scientific debate and assessment with peers from other....

- Waltham, MA
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Pharmaceutical company is hiring an Associate Director Medical Writing for their Waltham Massachusetts location.We are a leader in innovative medicines that address the unmet needs and challenges of people living with debilitating diseases. As a fully integrated global biopharmaceutical company, we apply our scientific expertise, proprietary technologies, and global resources to develop products that are designed to make a meaningful difference in the way patients manage their disease. Our....

- Norwood, MA
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Manufacturing Associate (five needs) 1st and 2nd Shifts available 6 month contract, and renewable up to 4 years Company is seeking a cGMP Manufacturing Associate for mRNA Manufacturing of Personalized Cancer Vaccines. This position will eventually transition from Cambridge, MA to our new GMP Manufacturing site in Norwood, MA. The individual in this role will be part of a cohesive team responsible for producing GMP mRNA-based personalized cancer vaccines for evaluation in human clinical trials.

- Madison, NJ
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Top Tier Pharmaceutical company (with focus in Cardio, respiratory, CNS, Psych and more) in Madison, NJ is looking for a new Director, Clinical Development for to add to this growing team!The Director Clinical Development will report directly to the Vice President and is responsible for the scientific, strategic, therapeutic, and operational management of programs to evaluate, register, and market pharmaceutical agents. Lead and direct study programs, activities, and teams for one or more....

- Buffalo, NY
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Clinical Project Manager As a Clinical Project Manager (CPM), you will work in a matrix management environment and serve as the primary contact for interdepartmental and external study contacts. This experienced CPM role is responsible for managing all stages of a clinical study within GCP and ICH guidelines when direct management by the sponsor is required. The CPM may also function as the liaison and provide support for sponsor managed studies in an international setting, and, may oversee....

- Buffalo, NY
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Clinical Research Associate POSITION OBJECTIVE: Work within a clinical team setting to ensure compliance with protocol and overall clinical objectives. Essential Job Functions/ResponsibilitiesParticipates in the preparation and/or review of draft protocol and informed consent documentsPossesses detailed knowledge of the study protocol and its associated activities and timelinesParticipates in conference calls, prepares agenda and summariesCoordinates with project team and other study personnel

- Cranford, NJ
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Clinical Research Associate POSITION OBJECTIVE: Work within a clinical team setting to ensure compliance with protocol and overall clinical objectives. Essential Job Functions/ResponsibilitiesParticipates in the preparation and/or review of draft protocol and informed consent documentsPossesses detailed knowledge of the study protocol and its associated activities and timelinesParticipates in conference calls, prepares agenda and summariesCoordinates with project team and other study personnel

- Cranford, NJ
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Safety Physician POSITION OBJECTIVE: Supports the Pharmacovigilance team in reviewing, querying, documenting and reporting on all serious adverse events (SAE) & Suspected Unexpected Serious Adverse Reactions (SUSAR) cases related to clinical studies. Essential Job Functions/ResponsibilitiesProvide timely and sound medical review of individual case safety reports (ICSR) from clinical trials.Actively participates in the case initiation process (case triage) and case data inputting/data entry

- Cranford, NJ
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As a Clinical Study Monitor, you will work within a clinical team setting to ensure study compliance with protocol, FDA and ICH guidelines. Essential Job Functions/Responsibilities · Ensure the Sponsor, Investigator, and study team adhere to current FDA regulations, applicable ICH/GCP guidelines, local policies and standard operating procedures. · Adhere to monitoring plan protocols; e.g. monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring....

- Buffalo, NY
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Senior Clinical Research Associate POSITION OBJECTIVE: Work within a clinical team setting to ensure compliance with protocol and overall clinical objectives. Essential Job Functions/ResponsibilitiesParticipates in the preparation and/or review of draft protocol and informed consent documentsPossesses detailed knowledge of the study protocol and its associated activities and timelinesParticipates in conference calls, prepares agenda and summariesCoordinates with project team and other study....

- Cranford, NJ
new job!

Senior Clinical Research Associate POSITION OBJECTIVE: Work within a clinical team setting to ensure compliance with protocol and overall clinical objectives. . Essential Job Functions/ResponsibilitiesParticipates in the preparation and/or review of draft protocol and informed consent documentsPossesses detailed knowledge of the study protocol and its associated activities and timelinesParticipates in conference calls, prepares agenda and summariesCoordinates with project team and other study....

- Cranford, NJ
new job!

Clinical Research Physician Global Oncology Pharmaceutical company is expanding and looking to add an MD Strong base salary and benefits and long term incentives POSITION OBJECTIVE: The Clinical Research Physician will be dedicated to providing a leadership role on a matrix team dedicated to stage appropriate clinical development of multiple innovative compounds. He or she will lead the development of clinical strategies for compounds and drive their successful implementation. Essential Job....

- Cranford, NJ
new job!

Clinical Research Physician Global Oncology Pharmaceutical company is expanding and looking to add an MD Strong base salary and benefits and long term incentives POSITION OBJECTIVE: The Clinical Research Physician will be dedicated to providing a leadership role on a matrix team dedicated to stage appropriate clinical development of multiple innovative compounds. He or she will lead the development of clinical strategies for compounds and drive their successful implementation. Essential Job....

- Cranford, NJ
new job!

Global Pharmaceutical company is hiring a \ for their growing company. Our Clinical Trainer is responsible for identifying and implementing Clinical Development staff training needs. They may benchmark Clinical SOPs and insure SOP training is completed and up to date. The Clinical Operations Trainer may also periodically co-monitor and evaluate staff performance and provide guidance for performance, improvement and adherence to FDA and SOP requirements. They may liaise with US and Taiwan....

- Cranford NJ & Buffalo NY, NJ
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POSITION OBJECTIVE: Provide Statistical Programming Support for Clinical Data Analysis and Submission. Essential Job Functions/Responsibilities This role is expected to contribute to the quality of data analysis and reporting deliverables for phase I to III clinical trials. Provide programming support for the clinical study team by generating and maintaining patient profiles, tables, listings, figures and other types of outputsCreate annotated CRFs, mapping specifications and datasets per SDTM

- Cranford NJ & Buffalo NY, NJ
new job!

POSITION OBJECTIVE: Provide Statistical Programming Support for Clinical Data Analysis and Submission. Essential Job Functions/Responsibilities This role is expected to contribute to the quality of data analysis and reporting deliverables for phase I to III clinical trials. Provide programming support for the clinical study team by generating and maintaining patient profiles, tables, listings, figures and other types of outputsCreate annotated CRFs, mapping specifications and datasets per SDTM


POSITION SUMMARY: Seeking an engineer to lead projects in support of small molecule clinical and commercial manufacturing processes. The individual will design, develop, scale-up and optimize robust drug product unit operations that provide high product quality at various scales ranging from R&D to cGMP manufacture. Strong collaboration is expected with internal early R&D groups, internal commercial partners, and external third party CMOs. The candidate should have strong communication

- NC
new job!

Responsibilities:-Must be fully capable of developing analytical methods based on experience, literature search, etc.-Design, develop, conduct and/or review experiments including method development and method transfer; perform methods validations utilizing typical instrumentation including but not limited to LC, MS, GC, etc.-Interpret data from routine and non-routine analyses in order to develop workable test methods and/or deduce and test mechanistic or systematic hypotheses;-Familiarity....

- Cincinnati, OH
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Lead and participate in continuous improvement projects supporting the manufacture of sterile pharmaceutical products for commercial and clinical supplies. Define, measure, analyze, and propose improvements to current processes and systems. Author and execute engineering studies, technical reports, change controls, and validation protocols necessary to support implementation of project. This position will work closely with Line Management and Department Leaders to execute projects focused on....

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