- Merck & Co. (Rahway, NJ)
- …adoption of cultural competence, health literacy, and teach back in clinical investigator training.Ensure policies and procedures are in place to deliver on 100% ... compliance with global disclosure requirements, data access and all voluntary company policies.Review and approve local country disclosure SOP's to ensure alignment with FDAAA and EudraCT process and data content.Develop strategies to maintain public data… more
- 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)
- …Lead and study team leader. Review and approve Vendor invoices, including investigator grants and pass through costs.Ensure study budget is reconciled with Finance ... including Vendor kick-off meetings, study team meetings, regional team meetings, investigator meetings and training. Note that vendor management is not limited… 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)
- …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)
- …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)
- …(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
- 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)
- …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)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator 's Brochure (IB), integrated safety summaries, abstracts and planned publications ... by participation in project/trial groups/teams established, as appropriate and conducts Investigator training as required Provide answers to enquiries from HAs and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for submissions, eg, clinical protocols and study reports, preclinical reports, investigator brochures, application summary documents, etc. Research and analyze the ... evolving competitive and regulatory landscapes to maintain current knowledge Effectively managing timelines while working in a fast-paced and dynamic environment across both time zones and cultures Physical Requirements 0-10% overnight travel required. Ability… more
- Memorial Sloan Kettering Cancer Center (New York, NY)
- …Kettering Cancer Center is seeking a full-time mid-to senior level Clinical Investigator to lead the Program in Myelodysplastic Syndromes. The Leukemia Service at ... MSKCC consists of 20 clinical and laboratory based faculty engaged in the clinical care of patients with myeloid and lymphoid malignancies, innovative clinical and translational research, and education. Our clinical and research programs span across our… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …meetings (including regulatory agencies, advisory boards, expert meetings, congresses, investigator meetings etc.) Overall accountable for medical input to ad-hoc ... and pre-project business activities Leader of leaders and responsible for the development of direct reports to improve their current performance and future potential through coaching and development opportunities Overall responsible for developing the area… 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
- New York State Civil Service (Brooklyn, NY)
- …Center For The Protection Of People With Special Needs Title Internal Investigator 1 (Justice Center) / Trainee 1/2 Occupational Category Enforcement or Protective ... completion of a two-year traineeship leads to appointment as an Internal Investigator 1, SG-18.)OR six years* of investigative experience** for appointment to… 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
- 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
