- 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
- 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
- Formation Bio (New York, NY)
- …Support protocol development and development of essential documents (eg, Investigator 's Brochures, informed consent forms) by providing critical operational ... insights. Remain current on emerging industry trends, regulatory updates, and best practices, pivoting operational strategies to maintain competitive advantage. AI and Technology Enablement Leverage AI-powered tools and technology platforms to streamline… more
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- New Jersey Institute of Technology (Newark, NJ)
- Title: Civil Rights Investigator Department: SVP HR & Institutional Access Reports To: Assistant Vice President, Institutional Access Position Type: Staff Position ... direction of Assistant Vice President of Institutional Access, the Civil Rights Investigator and Intake Coordinator will play a significant role in conducting intake… more
- City of New York (New York, NY)
- …a veteran law enforcement professional for the position of Senior Detective Investigator . The responsibilities of the position include, but are not limited to ... Interview witnesses and arrange for witness protection at the direction of the Chief Investigator . - Other duties as assigned. PREFERRED SKILLS - Three or more years… more
- New York State Civil Service (New York, NY)
- NY HELP No Agency State Inspector General, Office of Title Investigator (NYC (Lower Manhattan) Office) Occupational Category Enforcement or Protective Services ... any time once the position(s) has been filled.To apply for the Investigator position located in NYC, please visit https://bit.ly/NYSOIGRecruiting. Be sure to enter… more
- Allied Universal (Edison, NJ)
- …Allied Universal(R) is hiring a Special Investigations Unit (SIU) Investigator . Special Investigations Unit (SIU) Specialists investigate claims with red ... + Ability to be properly licensed as a Private Investigator as required by the state where work Is...of the following professional industry certifications: + Certified Fraud Investigator (CFE) + Certified Insurance Fraud Investigator … more
- Bank of America (New York, NY)
- GFC Investigator Charlotte, North Carolina;Jacksonville, Florida; Atlanta, Georgia; Plano, Texas; Newark, Delaware; New York, New York; Chandler, Arizona; Tampa, ... must be at least 18 years of age.** Acknowledge (https://ghr.wd1.myworkdayjobs.com/Lateral-US/job/Charlotte/GFC- Investigator \_25027425-2) **Job Description:** At Bank of America, we are… more
