| Associate Vice President, Cancer Signaling |
| The primary responsibilities include strong scientific management of drug discovery and development programs targeting cancer signaling pathways. |
| Location: NEW YORK |
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| Clinical Data Manager |
| Performs data management activities under the direction of the Lead Data Managers and Director of Data Management in a predominantly outsourced Data Management model: reviews edit specifications and database setup and performs UAT activities on clinical databases; performs data review; reviews work of CROs and tracks deliverables with respect to study timelines. |
| Location: CALIFORNIA |
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| Clinical Innovation Specialist |
| Serves as liaison between clinical trial teams, line functions and the Clinical Support Innovation Group. Responsibilities include working with a clinical trial management system and other applications as needed. |
| Location: NEW JERSEY |
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| Clinical Safety Associate |
| Demonstrates knowledge of safety concepts (ICH and FDA guidelines). Performs a review of ancillary documentation accompanying individual case safety reports and identifies pertinent clinical information for incorporation into the case narrative. Performs data entry and coding in safety database for all molecules. |
| Location: CALIFORNIA |
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| Clinical Scientist I or II |
| Under supervision of a Clinical Leader or Clinical Program Leader, will lead a phase III clinical trial in accordance with FDA/ICH guidelines, good clinical practices and standard operating procedures interacting with the Global Clinical Operations/CRO and Global Clinical Professional Resources/CRO and ensuring that the trial objectives are met and studies are delivered within agreed timeline and budget. |
| Location: NEW JERSEY |
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| Clinical Scientist, Respiratory |
| Under supervision of a Clinical Leader or Clinical Program Leader, will lead a clinical trial in accordance with FDA/ICH guidelines, good clinical practices and standard operating procedures interacting with the Global Clinical Operations/CRO and Global Clinical Professional Resources/CRO and ensuring that the trial objectives are met and studies are delivered within agreed timeline and budget |
| Location: NEW JERSEY |
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| Clinical Tiral Assistant, CNS/Psych |
| Support the clinical scientist in tracking and managing study supplies, study documentation, enrollment, safety letters, Data review –create and review data listings, maintaining study files, Follow up with study sites. |
| Location: NEW JERSEY |
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| Clinical Trial Coordinator |
| Responsible for providing operational and program level support for several Phase I/II clinical trials under the leadership of the assigned CTL Manager |
| Location: NEW JERSEY |
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| Contract Manager III |
| Negotiate and finalize clinical trial agreements, contract research organizations (CROs) agreements, general service agreements, consultancy agreements, lab services for Translational Sciences Outsourcing. Identifies potential vendors and negotiates budgets. |
| Location: NEW JERSEY |
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| Data Manager, Oncology |
| Responsible for providing timely and professional ongoing quality management of clinical trial data by identifying errors/inconsistencies in CRF data and ensuring their resolutions in order that databases can be declared clean and locked according to strict performance standards. |
| Location: NEW JERSEY |
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| Deputy Director / Global Regulatory Strategist |
| Responsible for planning and managing global regulatory drug activities for assigned projects within an specific therapeutic area. |
| Location: NEW JERSEY |
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| Drug Safety Associate |
| Perform data entry of all cases within the scope of Operations responsibility; demonstrate proficiency at writing event summary narratives for all cases within the scope of Operations responsibility |
| Location: CALIFORNIA |
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| Drug Supply Management Supply Chain Manager |
| Has operational end to end responsibility for assigned supply activity. Leads and manages demanding projects and network activities and participates in cross-functional teams. |
| Location: NEW JERSEY |
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| Global Studies Leader, Phase III |
| Provides direction and leadership to one or more study teams to ensure delivery of all cross functional activities to meet study plans outlined by the clinical development plan |
| Location: CALIFORNIA |
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| Global Trial Manager |
| This position will be accountable for the successful execution of global clinical trials assigned by the Clinical Program Leader with a focus on Oncology. Responsible for resource allocation within agreed timelines and budget, with high quality and meeting all the SOP and regulatory requirements. 15 - 20% travel. |
| Location: CALIFORNIA |
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| IVRS Clinical Coodinator |
| Primary account manager for Clinical Trials Portal, Interactive Response Technology and ClinAdmin supporting the Clinical Franchises, Translational Medicines, Oncology and other businesses as needed. |
| Location: NEW JERSEY |
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| Junior Clinical Research Associate |
| Support the clinical team in tracking and managing study supplies, study documentation, enrollment, safety letters, Data review –create and review data listings, maintaining study files. |
| Location: CALIFORNIA |
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| Medical Information Associate |
| Responds to all on-label and off-label customer inquires for all company marketed and investigational agents received via phone, fax or e-mail. |
| Location: NEW JERSEY |
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| Medical Science Liaison |
| Ideal candidate will have a MD or PharmD with strong oncology background. Will communicate with doctors, internally and externally. |
| Location: NEW JERSEY |
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| Paralegal / Legal Assistant |
| A paralegal for the Business Development Law Group focused on mergers, acquisitions, divestitures and strategic alliances. |
| Location: NEW JERSEY |
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| Project Manager |
| Hiring Director is looking for solid clinical trial management (6-7 years), Phase IV, strong CRO experience including finance, budgets, request for proposals, someone with project management skills that can work cross functionally, solid business sense. CNS, Endocrinology |
| Location: NEW JERSEY |
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| Quality & Compliance Expert (Pharmacovigilance) |
| Implement quality processes that require medical expertise including adverse event handling, aggregated reporting and signal detection & management |
| Location: NEW YORK |
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| Regulatory Affairs Specialist |
| Contributes to the strategic planning and preparation of regulatory submissions and supports the formatting, organization, and structuring of major regulatory submissions for his/her assigned products and/or therapeutic area(s) in collaboration with other departmental representatives. |
| Location: NEW JERSEY |
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| Senior Clinical Research Associate / CRA |
| Provide scientific and technical leadership for the successful study initiation, execution, and completion. Contribute to the development and general design of the concept protocols. Author and develop regulatory compliant clinical protocols. Provide input on site selection activities ensuring selection of qualified investigators to meet the study objectives. Oversees tracking and maintenance of all study related documents and correspondence, ensuring each decision affecting study outputs are fully documented in accordance with SOPs and compliant to regulatory review. |
| Location: CALIFORNIA |
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| Senior Clinical Scientist |
| In collaboration with the project physician, directs the planning and implementation of clinical programs to meet corporate and clinical research goals. Advanced Degree in Life Sciences (e.g., BS in nursing, pharmacy or related medical field), minimum 7 years experience in clinical research development or equivalent. |
| Location: NEW JERSEY |
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| Senior Clinical Scientist, Phase III |
| Participate in all aspects of clinical development and study management, which includes providing logistic and scientific support to planned and ongoing trials. Ideal candidate will possess very strong operations/clinical development experience in phase III – IV global trials. Large CRO/Vendor MGMT, Strong Start up and Patient Recruitment experience is a must. |
| Location: NEW JERSEY |
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| Senior Drug Safety Associate |
| Responsible for participating in the collection, safety review, processing and reporting of adverse events data in compliance with applicable FDA and global regulations and Client Standard Operating Procedures and guidelines. |
| Location: CALIFORNIA |
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| Senior Drug Supply Manager |
| Has operational end to end responsibility for assigned supply activity. Leads and manages demanding projects and network activities and participates in cross-functional teams. |
| Location: NEW JERSEY |
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| Senior Manager, Strategic Initatives |
| Responsible for the stewardship of the Division's strategic planning, business development and coordination of departments |
| Location: NEW YORK |
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| Senior Medical Writer |
| Act as the medical writing expert responsible for the research, writing and editing of study level and submission level documents. |
| Location: NEW JERSEY |
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| Associate Director, Quality Monitoring & Compliance, Clinical Operations |
| Site monitoring experience; Strong BLA/NDA experience (readiness); QA/compliance GCP experience. |
| Location: CALIFORNIA |
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| Clinical Trial Manager |
| Accountable for the day-to-day operations and execution of clinical trials to ensure the trial activities are conducted per ICH/GCP and regulatory compliance. |
| Location: CALIFORNIA |
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| Clinical Trials Coordinator |
| responsible for collecting and reviewing regulatory documents from multiple clinical trial sites as well as maintaining the trial master files. The coordinator will prepare and submit Regulatory and Ethics submissions. |
| Location: NORTH CAROLINA |
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| Data Manager - Oncology |
| Responsible for providing timely and professional ongoing quality management of clinical trial data by identifying errors/inconsistencies in CRF data and ensuring their resolutions in order that databases can be declared clean and locked according to strict performance standards |
| Location: NEW JERSEY |
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| Global Project Leader, Hematology |
| Responsible for the global leadership of the Product Development project in the hematology therapeutic area on behalf of the respective Business Unit. |
| Location: NEW JERSEY |
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| Global Studies Manager |
| Provides direction and leadership to one or more clinical operations teams. Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management. |
| Location: CALIFORNIA |
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| Manager, Risk Management Standards |
| Perform the following Services with activities including but not limited to: RMP Development Maintenance, Global RMP Governance, RMP Operations, Commercial Support and Liaison to Client Partners. |
| Location: NEW JERSEY |
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| Medical Information Associate |
| Liaise with key partners across the organization in developing and executing the Medical Information strategy for assigned products. Lead Global Standard Response Committees for assigned products to ensure completeness and currency of information used to respond to medical information queries globally . |
| Location: CALIFORNIA |
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| Medical Information Associate |
| Develop and maintain consistent and compliant Medical Information processes and systems for use across all affiliates and coordinate ongoing communications to the Roche Medical Information community |
| Location: CALIFORNIA |
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| Regulatory Affairs Specialist |
| Prepares and manages regulatory submissions (US/EU). Submissions include 510k, PMA supplements and IDE’s. 510k, PMA supplement experience is a mandatory for this position. Conducts critical reviews of key technical documents. |
| Location: NEW JERSEY |
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| Regulatory CMC Manager |
| Under supervision, provide strategic and operational global CMC regulatory direction and documentation for projects/products covering development, registration and approval/post approval activities. |
| Location: NEW JERSEY |
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| Senior Clinical Data Coordinator |
| Direct and prioritize work of others. Serve as a resource for clinical data management concepts, standards and processes. Maintain a project-level perspective on data management issues, activities and deliverables. Manage projects resourced externally via contract research organizations or corporate partners. |
| Location: CALIFORNIA |
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| Senior Data Manager |
| Provides input to the development of the Study protocol. Responsible for keeping members fully and promptly updated on the status of the data flow and the data quality throughout the lifecycle of the clinical trial/Registry. |
| Location: CALIFORNIA |
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| Senior Project Manager, Drug Development |
| Manages one or more high-level, complex non-technical projects within the constraints of scope, quality, time, and cost, to deliver specified requirements. Projects may be strategic in nature. |
| Location: PENNSYLVANIA |
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