- Formation Bio (New York, NY)
- …Oversee GXP, Data Integrity, and CSV activities across various entities, investigator sites, research organizations, clinical and nonclinical studies, PV vendors, ... and CDMOs. Maintain efficient systems and processes that ensure Formation Bio and its vendor network comply with GXP, and Computer validation standards. Provide leadership and direction to the quality assurance team, ensuring that all quality activities are… more
- Merck & Co. (Rahway, NJ)
- …PlanUpdate manuals/documentsDocument proper destruction of clinical supplies.Prepare Investigator trial file bindersObtain translations of documents Regulatory ... Planning: Organize meetings (create & track study memos/letters/protocolsSupport local investigator meetings where applicableSkills:Fluent in Local Languages and business… more
- Merck & Co. (Rahway, NJ)
- …forms, data analysis plans, and final reports/publications.Works with our company Investigator Study Program Committee to evaluate outcomes research study protocols ... for studies in local markets.Supports our company country affiliates to understand local needs, adapt health economic evaluations, customize Outcomes Research documents such as protocols and reimbursement dossier, which includes the development of the… more
- Merck & Co. (Rahway, NJ)
- …forms, data analysis plans, and final reports/publications.Works with our company Investigator Study Program Committee to evaluate outcomes research study protocols ... for studies in local markets.Supports our company's affiliates to understand local needs, adapt health economic evaluations, customize Outcomes Research documents such as protocols and reimbursement dossier, which includes the development of the worldwide… more
- Merck & Co. (Rahway, NJ)
- …well as preparation and presentation of the clinical supplies information at Investigator Meetings for assigned protocols. Support the collection of clinical supply ... chain metrics and/or participate in critical non-pipeline activities. Participate in Interactive Voice Response (IVR) System-development and User Acceptance Testing (UAT) for assigned studies. Utilization of key technological tools and systems for GCS planning… more
- Memorial Sloan-Kettering Cancer Center (New York, NY)
- …and retain outstanding faculty; build high-performing, inclusive teams; and grow multi- investigator research programs. + Track record of methodologic innovation and ... impactful scholarship; success securing federal, foundation, and/or industry funding. + Exceptional communication, collaboration, and stakeholder engagement skills; highest standards of professional ethics and integrity. **Core Skills:** + Strategic planning… more
- Eisai, Inc (Nutley, NJ)
- …planning. Research Support Facilitate review and follow up of submitted Investigator -Initiated Studies (IISs) and assist with Eisai sponsored trials.Serve as primary ... contact to external investigators who submit IISs. The MSL may also be involved with providing recommendations for site selection and scientific expertise to Investigators involved in company sponsored post-marketing studies.Professional Organization Support… more
- Eisai, Inc (Nutley, NJ)
- …management, and contribute to tumor assessment data cleaning for both investigator and independent reviews.Support reporting of imaging activities and progress to ... study teams and leadership, ensuring visibility into key milestones and initiatives.Assist global clinical operations during health authority inspections related to tumor assessments and procedures. Requirements PhD required in related scientific… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings.Support Fair Market Value process in evaluating study budgetsCollect ... to supervisor's attention.Track study metrics such as site start-up, Investigator /site performance, recruitment, regulatory documents, TMF filing and QC activities… more
- Eisai, Inc (Nutley, NJ)
- …relationship Research Support Facilitate review and follow up of submitted Investigator -Initiated Studies (IISs) and assist with Eisai sponsored trials. The MSL ... may also be involved with providing recommendations for site selection and scientific expertise to Investigators involved in company sponsored studies.REQUIREMENTS: Educational Requirements: Advanced terminal D degree in medical or health sciences (eg MD/DO,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the USOMA Plan. Provides medical review of expanded access programs (EAP) and, investigator -initiated studies (IIS) as part of a US IIS Review Committee, for ... engagement activities with key external stakeholders such as advisory boards, investigator interactions, congress activities, peer to peer discussions with key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the GMA Plan. Provides medical review of expanded access programs (EAP) and, investigator -initiated studies (IIS) as part of a Global IIS Review Committee, for the ... engagement activities with key external stakeholders such as advisory boards, investigator interactions, congress activities, peer to peer discussions with key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Interventional, Non-Interventional, Managed Access Programs, and Investigator -Initiated Studies.Provide comprehensive quality oversight for Medical Affairs ... stakeholders to uphold the ethical conduct of interventional, non-interventional, investigator -initiated trials, and managed access programs to the highest quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Inform Finance of deviations-Review and approve Vendor invoices, including investigator grants and pass through costs.- Quality and inspection readiness-Support ... inspection readiness and quality initiatives pertaining to assigned study(ies).-Serve as primary SME engaged in dialogue with inspector(s) to address study inquiries throughout course of HA inspection-Ensure trial master file is complete and accurate for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and other cross-functional and regional stakeholders.- Provides support in review of investigator -initiated studies (IIS) and may serve as deputy compound lead in ... Global IIS Review Committee meetings.- Leads external medical education and other scientific exchange activities in alignment with the Senior Director, such as scientific symposium and medical congresses, within legal and compliance regulations.- Collaborates… more
- Organon & Co. (Jersey City, NJ)
- …2.5 and labeling for regulatory submissions, contribute the authoring of Investigator Brochures, IND subsections, briefing books, submission modules, responses to ... pharmacology components of TMED study protocols, clinical study reports, Investigator Brochures, briefing books, IND subsections, submission modules and other… more
- Organon & Co. (Jersey City, NJ)
- …modules for regulatory submissions, contribute the authoring and review of Investigator Brochures, INDs, briefing books and other regulatory documents, as ... applicable. The Associate Director, Biopharmaceutics will be the primary author for module 2.7.1 for global regulatory submissions. **Responsibilities** + Provide support for the Biopharmaceutics Lead on early clinical development programs to ensure optimal… more
- Terumo Medical Corporation (Somerset, NJ)
- …health care compliance guidelines. + Provide high-level research support & investigator -initiated research. + Stay abreast of current scientific and treatment ... criteria, patient population and risk section). + Evaluate scientific soundness of investigator -initiated trial proposals so that the BU can take an informed… more
- Terumo Medical Corporation (Somerset, NJ)
- …clinical and nonclinical evidence. + Study (summary) protocols. + Write investigator brochures, interim and final clinical study reports, briefing documents ... (including internal summary reviews for internal and external purpose and Annotated papers). + Write abstracts and manuscripts . + Perform other job-related duties as assigned. **Working Conditions/Physical Requirements** This position can be remote, or office… more
- City of New York (New York, NY)
- …is seeking a law enforcement professional to serve as a Deputy Chief Detective Investigator within the Detective Investigator Squad & Crime Strategies Unit. This ... position will report directly to the Chief Detective Investigator . The responsibilities of the position include, but are...witness protection at the direction of the Chief Detective Investigator . - Other duties as assigned. PREFERRED SKILLS -… more
