- Merck & Co. (North Wales, PA)
- …and goals for approved, in-development, and active Company-sponsored trials and/or investigator -sponsored research studies. The RMSD serves as a role model for ... Center for Scientific Affairs (GCSA),Initiates discussions with SLs and/or potential investigators that include scientific/data exchange within our AOI to determine… more
- Eisai, Inc (Nutley, NJ)
- …partners to meet assigned timeframes and to assure consistency of case records and documentation.Responsible for evaluating, tracking, documenting and processing ... of coding practices among International offices.Interface with Clinical for investigator training Essential Functions Adverse event information collection, processing,… more
- Merck & Co. (Rahway, NJ)
- …best practices.Responsible for collaboration with functional outsourcing vendors, investigators , other external partners in assigned studies.As a customer-facing ... will build business relationships and represent our Company with investigators .Supports local and regional strategy development consistent with long-term corporate… more
- Merck & Co. (Rahway, NJ)
- …team, our company's Management, regulatory agencies, or individual investigators .Represent biostatistics in regulatory interactions including presentation at ... interpretation posed by the clinical monitors, regulatory agencies, and/or investigators .- -Participates with management in discussions with corresponding scientific… more
- Merck & Co. (North Wales, PA)
- …trials to the project team, management, regulatory agencies, or individual investigators .Provides responses to queries relating to study design, analysis, and ... interpretation posed by the clinical monitors, regulatory agencies, and/or investigators .-Is responsible for planning and ensuring the accuracy of Statistical Review… more
- Merck & Co. (Rahway, NJ)
- …to the project team, company Management, regulatory agencies, or individual investigators .Provides responses to queries relating to study design, analysis, and ... interpretation posed by the clinical monitors, regulatory agencies, and/or investigators .May represent biostatistics in regulatory interactions including presentation at… more
- Merck & Co. (Rahway, NJ)
- …scientific findings, research methodologiesIdentification of scientifically and operationally strong investigators who can assist in the development of our company's ... investigational and marketed drugsEstablishing communications with prominent clinical investigators in his/her particular field of interest, particularly those who… more
- Merck & Co. (Rahway, NJ)
- …scientific findings, research methodologies;Identification of scientifically and operationally strong investigators who can assist in the development of our ... companies investigational and marketed drugs;Establishing communications with prominent clinical investigators in his/her particular field of interest, particularly those… more
- Merck & Co. (North Wales, PA)
- …final approval Worldwide Marketing Applications, Clinical Study Reports, Protocols, Investigators ' Brochures before release from our company to external agencies ... and investigators .Represents Global Regulatory Affairs (GR) within internal committees to...pose an undue burden to business operations, in which case you may not be offered employment, or your… more
- Merck & Co. (Rahway, NJ)
- …and objectives especially during study start-up.Required to in/directly influence investigators , external partners and country operations and adheres to budget ... of how these impact study start-up.Ability to indirectly influence investigators , vendors, external partners and country managers to address...pose an undue burden to business operations, in which case you may not be offered employment, or your… more
- Merck & Co. (Rahway, NJ)
- …of data management tools.Provide inputs in to the preparation of the investigator meetings materials and makes him/her available for questions. May present data ... management instruction at investigator meetings based on business need and management decision.Participate...pose an undue burden to business operations, in which case you may not be offered employment, or your… more
- Tris Pharma (Monmouth Junction, NJ)
- …briefing documents, Investigational New Drug (IND) annual reports, Investigator 's Brochures, clinical study reports and scientific presentations including ... to produce statistical analysis plans and data displays; provides input to Case Report Form (CRF) design and data management processes; Performs periodic review… more
- TalentBurst, Inc (New York, NY)
- …Type: TravelPURPOSE AND SCOPE: Works under the supervision of the Principal Investigator (PI), Director and other site personnel as applicable. Conceptually applies ... ICH Guidelines. * Under the supervision of the Principal Investigator (PI) and appropriate management prepares and submits regulatory...review, verify and correct all data entered onto the case report form and to ensure appropriate maintenance of… more
- Merck & Co. (North Wales, PA)
- …stakeholders as needed.Build and maintain excellent relationships with clinical investigators , scientific leaders, external authors, journal editors, and congress ... then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please… more
- Aequor (West Chester, PA)
- …to establish and leverage relationships with external experts, clinical trial investigators , journal editors, and congress secretariats to drive high quality medical ... development, and documentation of action items Forecast financial resources with business case preparation and oversight as required and to deliver the publication… more
- Aequor (Piscataway, NJ)
- …to establish and leverage relationships with external experts, clinical trial investigators , journal editors, and congress secretariats to drive high quality medical ... development, and documentation of action items Forecast financial resources with business case preparation and oversight as required and to deliver the publication… more
- Merck & Co. (Rahway, NJ)
- …management in strategic planning of projects.Represent statistics in meetings with investigators and regulatory agencies in discussions about clinical trial issues ... then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please… more
- Insmed Incorporated (Bridgewater, NJ)
- …including clinical sections of IND submissions, IND Annual Updates / DSUR, Investigator Brochures and IMPD's Draft, briefing books, clinical sections for the NDA/CTD ... of SUSARs and contact with PIs in each reported SUSAR to understand the case assessment. Production of initial narrative to understand each individual case .… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and/or as part of a global team and as aligned to a business case , goals and/or future aspirations. Contributes to a continually changing environment, supporting a ... of, support to, and follow-up of audits and inspections Monitoring of the Investigator Portal for, and Central IRB/REB submission of, SUSARs for assigned clinical… more
- Merck & Co. (North Wales, PA)
- …development of local data generation study concepts and protocols.Reviews Investigator -Initiated Study proposals from key countries prior to headquarters submission ... then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please… more
