- Daiichi Sankyo, Inc. (Bernards, NJ)
- …support to uphold the ethical conduct of interventional, non-interventional, investigator -initiated trials, Managed Access programs and Collaborative Research to the ... support to uphold the ethical conduct of interventional, non-interventional, investigator -initiated trials, Managed Access programs and Collaborative Research to the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …on Harmonization (ICH) guidelines. This role emphasizes the management of Investigator Initiated Studies (IIS) and Collaborative External Sponsored Research (CESR) ... financial tracking.Vendor and Site Management: Direct and enhance interactions with investigator sites and other external vendors to ensure projects are delivered… 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)
- …and CSR safety narratives- May lead the development and updates of the Investigator 's Brochure (IB): author the clinical section and lead the development of the ... other sections in collaboration with the other authoring functions- Accountable for Protocol content/study design development- Contributes from a medical strategy standpoint to the development of clinical sections of study-level documents (eg, protocol,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …documents include, but are not limited to, clinical study reports, investigator brochures, regulatory briefing documents, and clinical and clinical pharmacology ... sections of INDs, NDAs, BLAs, MAAs. This role will also contribute to strategic planning and provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA submissions,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Implement strategies to accelerate company sponsored global non-registration studies and investigator initiated studies (IIS). Be one of the core members for ... the team designing the Global Life-cycle strategies and global IIS strategies.Committees: Lead Specific GMAC (cross-regional MA committee). Core member of Specific Oncology Global Brand Teams (GBT), Oncology Global Project Teams (development, GPT). Ad-hoc… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …documents include, but are not limited to, clinical study reports, investigator brochures, regulatory briefing documents, and clinical and clinical pharmacology ... sections of INDs, NDAs, BLAs, MAAs.. This role will also contribute to strategic planning and provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(TLF) and CSR safety narrativesMay lead the development and updates of the Investigator 's Brochure (IB): author the clinical section and lead the development of the ... other sections in collaboration with the other authoring functionsAccountable for Protocol content/study design developmentContributes from a medical strategy standpoint to the development of clinical sections of study-level documents (eg, protocol,… more
- Merck & Co. (Rahway, NJ)
- …and CRA on data findings and resolve via data queries with the Investigator siteTo evaluate protocol deviations for effect on data analysis and interpretationLock ... final data setsTo track and transfer external data to primary database or warehouseTo assist with studies being conducted paperless by using a Electronic Data Capture systemTo follow Good Clinical Practices (GCP), display unquestionable ethics, maintain… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to team members and track them to completionFollow up with investigator on status of investigations, Corrections, CPAs and Effectiveness checks.Perform ... investigations and train new investigators.Collaborate with team to determine if corrective actions adequately addressed root cause of NC event.Support tracking of deviations, events and key process parameters and provides reports to management on trending,… more
- MTA (New York, NY)
- Senior Equal Opportunity Investigator (C&D) Job ID: 8898 Business Unit: MTA Headquarters Location: New York, NY, United States Regular/Temporary: Regular Department: ... Date Posted: Sep 23, 2024 Description JOB TITLE: Senior Equal Opportunity Investigator SALARY RANGE: $105,000 - $116,133 HAY POINTS: 551 DEPT/DIV: Diversity and… more
- MTA (New York, NY)
- Equal Opportunity Investigator Job ID: 8544 Business Unit: MTA Headquarters Location: New York, NY, United States Regular/Temporary: Regular Department: Date Posted: ... Aug 26, 2024 Description JOB TITLE : Level I: Junior Equal Opportunity Investigator Level II: Equal Opportunity Investigator Level III: Senior Equal Opportunity … more
- Bank of America (New York, NY)
- Global Financial Crimes Sr. Investigator Charlotte, North Carolina;New York, New York; Plano, Texas; Dallas, Texas; Chicago, Illinois **Job Description:** At Bank of ... are adequately documented. The Senior Global Financial Crimes ("GFC") Investigator , under broad supervision, partners with investigators to ensure investigative… more
- MTA (New York, NY)
- Senior Equal Opportunity Investigator Job ID: 4633 Business Unit: MTA Headquarters Location: New York, NY, United States Regular/Temporary: Regular Department: Date ... Posted: Jun 27, 2024 Description JOB TITLE: Senior Equal Opportunity Investigator SALARY RANGE: $105,000 - $116,133 HAY POINTS: 551 DEPT/DIV: Department of Diversity… more
- City of New York (New York, NY)
- …its vendor responsibility determinations. NYCHA-OIG is seeking a Vendor Integrity Investigator who will be responsible for conducting background checks of for-profit ... and principals seeking to do business with NYCHA. The investigator will use DOI/NYC internal databases and public websites...submit data. As a subset of this work, the investigator may also investigate vendor fraud cases and/or relevant… more
- MTA (New York, NY)
- Equal Opportunity Investigator Job ID: 6841 Business Unit: MTA Headquarters Location: New York, NY, United States Regular/Temporary: Regular Department: Date Posted: ... Jun 27, 2024 Description JOB TITLE : Equal Opportunity Investigator SALARY RANGE : $90,000 - $95,000 HAY POINTS : 451 DEPT/DIV: Department of Diversity & Civil… more
- City of New York (New York, NY)
- …to the Vice President of Quality Assurance, the Quality Assurance (QA) Investigator is responsible for identifying discrepancies between current NYCHA practices and ... governing regulations (City, State and Federal). The QA Investigator will plan, direct and control monitoring projects involving possible illegal, fraudulent or… more
- City of New York (New York, NY)
- …Employment Opportunity & Diversity Office seeks to hire an experienced EEO Investigator who will be responsible for conducting complex complaint investigations, as ... supervising more junior investigators in the execution of their assignments. The EEO Investigator will report directly to the Assistant Commissioner of EEO&D or the… more
- City of New York (New York, NY)
- Job Description IMPORTANT NOTE: CANDIDATES WITH A PERMANENT ASSOCIATE FRAUD INVESTIGATOR CIVIL SERVICE TITLE OR CANDIDATES WHO FILED FOR THE ASSOCIATE FRAUD ... INVESTIGATOR EXAM NO. 4013 ARE ENCOURAGED TO APPLY. PLEASE...Associate Fraud Investigators perform related work. The Associate Fraud Investigator will maintain cooperative relationships with authorized representatives, from… more
