- 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
- 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
- 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 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
- 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
- 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
- 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
- Parexel (Trenton, NJ)
- **Key Accountabilities:** **Contracting deliverables** + Exercise good judgment in balancing the risks to the client in making budget and contractual decisions ... against the impacts to client clinical trial timelines + Follow client processes to develop, negotiate, track and execute global clinical study agreements with institutions and investigators participating in sponsored clinical trials + Work with partners to… 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)
- …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
- 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
- Parexel (Trenton, NJ)
- …with feasibility leaders, solution consultants + Participate in team project and investigator meetings + Provide training of study teams on TA indication and ... preferred -Experienced as a Physician in Industry or as a clinical trial investigator with significant clinical research experience The ability to travel 15-20% is… 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
- Port Authority of New York and New Jersey (Jersey City, NJ)
- …training courses. + The Supervising Safety Engineer may act as a principal investigator for the department and respond to or coordinate staff response to incident ... sites and establish the chain of events immediately preceding the incident and formulate a safety analysis / investigation; act as the liaison and collaborate with Agency partners and stakeholders on incidents and accidents involving Port Authority, tenant,… more
- Parexel (Trenton, NJ)
- …for a wide range of documents, including but not limited to investigator 's brochures, clinical study protocols and reports, integrated summaries, literature reviews, ... and SOPs. - Ensure that documents comply with International Conference on Harmonization guidelines, Sponsor Pharmaceuticals SOPs, and Good Clinical Practices. Collaborative relationships - Collaborates effectively with lead writers and project teams to develop… more
- Parexel (Trenton, NJ)
- …for a wide range of documents, including but not limited to investigator 's brochures, clinical study protocols and reports, integrated summaries, literature reviews, ... and SOPs. + Ensure that documents comply with International Conference on Harmonization guidelines, SOPs, and Good Clinical Practices. **Requirements:** + At least 15 years of medical writing experience in the pharmaceutical industry + Ability to write and… more
- Port Authority of New York and New Jersey (Jersey City, NJ)
- …7. Forensic Investigations: 8. Serve as the principal forensic technical investigator for cyber incidents. 9. Solution Design and Implementation: 10. Design ... and implement solutions for monitoring and responding to cyber threats and incidents. 11. Collaboration with OIG and PAPD: 12. Establish operational relationships with the Office of the Inspector General (OIG) for investigating cyber incidents. 13. Establish… more
