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Director, Medical Information for this leading pharmaceutical company in New England S Headquarters in Waltham, MA Looking for Senior Engineer for drug product unit operations- leadership scale-up and optimization in development from R&D to cGMP Phase 3 manufacture to process validation. Experience with continuous manufacturing, scale-up and PAT implementation is strongly desired. The individual is expected to integrate QbD principles, guide experimental design with a focus on process....


Global Pharmaceutical company is looking for a Clinical Partnership Liaison Must have pharmaceutical, Biotech or CRO experience at this senior level. located in NYC must work in the office three days/week The Partnership Liaison is a key leadership role within Clinical Operations Business Operations Management. The role is responsible for implementing and driving the success of the Clinical Development sourcing strategy. The role is accountable for Clinical Development alliances with clinical....

- Jersey City, NJ

Pharmaceutical company in Jersey City, NJ in need of Clinical Research Associate Responsible for monitoring of single and multi-site clinical trials. Assures adherence to international Commission on Harmonization (ICH), Good Clinical Practices (GCP), and Code of Federal Regulations (CFR). Assures compliance with institutional Standard Operating Procedures (SOPs) and Policies, protocol requirements, and institutional reporting requirements. Performance of this position requires coordination and


Global Pharmaceutical company is hiring a GLOBAL HEAD RESOURCE MANAGEMENT AND ANALYTICS Position Purpose: Leadership role in Business Operations Management in Clinical Operations with strategic oversight and accountability for the delivery of all aspects of resource planning, capacity management & analytics (metrics) within Clinical Operations.Propose, deliver & implement resource strategies, processes, analyses and tracking for the provision of resource management information to....

- Any US State

Global Pharmaceutical company is hiring Clinical Project Manager for their Clinical Development studies Day to day management of studies This position is responsible for providing oversight of Phase 1 to Phase 4 clinical trial implementation; ensuring clinical studies are conducted in a timely manner with milestones being achieved within budget.Essential FunctionsThe Clinical Project Manager for this Pharmaceutical company- will:Utilize Project Management techniques and methodologies to plan,....


The Senior Manager, Clinical Development CNS will participate in internal process improvement activities within R&D and Clinical Development. Main Areas of Responsibilities supports the Clinical Program Lead and Clin.Sci. Lead in the development of the Clinical Development Plan and associated clinical trial content (e.g., protocols, IBs/IDFUs, CRFs, CSRs, regulatory submissions and publications) by contributing to scientific/clinical information aligned with the strategy. key Clinical....

- Norwood, MA

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.


Pharmaceutical client in NYC hiring two Clinical Research Study Managers for their Global Trials The Clinical Research Study Leader (CRSL) will provide leadership to global Study Management Teams responsible for delivering First in Man, Proof of Concept through to Phase 3 registration studies in various indications. The CRSL will manage a number of studies, either for a single indication or across different indications. The CRSL is accountable for the strategic and tactical study activities,....


Three Medical Directors needed The Medical Director is a board-certified physician who has a history of clinical practice, and has significant experience in the cardio therapeutic area, Endocrinology or Renal, Nephrology therapeutic areas. The Medical Director is knowledgeable of the actions of regulatory bodies, in particular FDA, and has experience in clinical trials. An ideal candidate should have significant experience in renal cardio disease management and would thrive on proactively....


Top Tier Pharmaceutical Company hiring Endocrinologist Field Physician or Senior Field Physician Endocrinology and Diabetes A Field Physician/Sr. Field Physician US Medical Affairs, is a board-certified endocrinologist who has a history of clinical practice, who has significant experience in the therapeutic area of endocrinology and secondary prevention. They will have solid peer relationships with key opinion leaders in their therapeutic area (TA). An ideal candidate should have significant....


Top Tier Pharmaceutical Company hiring Cardiologist Field Physician or Senior Field Physician Cardiology A Field Physician/Sr. Field Physician US Medical Affairs, is a board-certified cardiologist who has a history of clinical practice, who has significant experience in the therapeutic area of cardiology and secondary prevention. They will have solid peer relationships with key opinion leaders in their therapeutic area (TA). An ideal candidate should have significant experience in their....


Global Pharmaceutical Company is hiring three Clinical Operations Directors (Vaccine or rare disease or Oncology) This position will be responsible for initiating and leading phase 1 and 2 clinical trials development, set-up, implementation and completion. This will be accomplished by working with the internal project team and through a preferred provider CRO and other external contractors. This role will report internally to the Head of Clinical Operations and work closely with the Regulatory


Top Tier Pharmaceutical company (with focus in RESPIRATORY, CNS, Diabetes, Cardio, GI and more) in Madison, NJ is looking for three Clinical Trials Manager Consultants for Clinical Trials Group This is a one year contract and can continue for up to 4 years (1099 or w-2)SummaryParticipate in all aspects of clinical development and study management under the direction of the Director, or designee, which includes providing scientific, and/or logistical support to planned and ongoing trials CTM –....


The Clinical Operation Lead is responsible for developing operational strategy for one or more clinical studies, and leading the cross-functional Study Management Team to align and deliver on study goals of data quality, timelines, budget and GCP compliance in support of overall program level plans. Responsibilities: The Clinical Operations Lead will independently plan all aspects of the clinical operations for one or more clinical studies and oversee the execution of studies keeping the....


Clinical/Sr. Clinical Program Coordinator (Contract) The Clinical/Sr. Clinical Program Coordinator is responsible for supporting the clinical development operations team across multiple clinical studies and programs, as well as clinical development operations department-wide activities and initiatives. Responsibilities: Study team and department support QC study documentsCoordinate sponsor team review and finalization of key study documentsSupport study team during key deliverable....


The Director/Sr. Director of Clinical Development Operations is responsible for clinical operations planning, oversight and execution of multiple studies within one or more clinical development programs. Strategic development and coordination of operational approaches, guiding study level staff, and optimizing vendor performance. Sophisticated internal (cross functional team members) and external (KOLs, site staff) stakeholder communication and interface. Manage and/or mentor Clinical Trial....


Top Pharmaceutical company is looking for a Senior Clinical Data Manager Contractor in their Madison, NJ office one year contract and can renew up to 4 years at a time, benefits included Description: Position Summary The Senior Manager, Clinical Data Management is responsible for leading internal and outsourced Clinical Data Management activities in support of Clinical Research studies, managing the definition of Case Report Form (CRF) requirements, creation of the Data Management Plan,....

- Albany, NY

Automation Engineer Summary: Responsible for designing, developing, implementing, and maintenance of industrial computerized process control and process monitoring systems in a biopharmaceutical manufacturing cGMP environment. Essential Duties and Responsibilities include, but are not limited to the following: - Provide technical automation support and troubleshooting to Manufacturing, Quality Control, and Facilities according to established SOPs and departmental practices. - Perform....


Principal Automation Engineer Reports to: Automation Manager Summary: Performs advanced technical planning, system integration, maintenance, verification, and validation of PLC and HMI based automated process control systems and process monitoring systems in a biopharmaceutical manufacturing cGMP environment. The Principal Engineer is the site Subject Matter Expert on automated process control and monitoring systems for their area of responsibility and is recognized as a technical expert by....


Principal Scientist GLOBAL PHARMACEUTICAL COMPANY is hiring a Technical lead to design and execute analytical related aspects of pharmaceutical drug product development. Has broad and in-depth understanding of analytical techniques to support testing of a range of small molecules and macromolecules. Understanding of biomolecules and bioanalytical techniques including test methods to support clinical studies such as pharmacokinetics studies is desirable. Has method development/validation....

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