- Merck & Co. (Rahway, NJ)
- …clinical research setting.Business acumen and/ or financial background; preferably Investigator grants and payments.Strong understanding and dedication to our ... company's Leadership principles, with an emphasis on relationship development, rapid decision making, conflict resolution, and team building instincts, with the ability to build partnerships and collaborate both internally and externally.Strong collaboration… more
- Daiichi Sankyo, Inc. (Louisville, KY)
- …and study committee members for DSI clinical research programs, 2) investigator -initiated research study proposals, 3) speakers for DSI Brand Speaker programs, ... 4) advisors for DSI scientific, clinical and marketing advisory boardsGathering customer insights regarding DSI and competitor products to help inform medical and commercial decision makingEnhanced professional expertise through attendance of select scientific… more
- Merck & Co. (North Wales, PA)
- …country-specific data supporting pricing and reimbursement Work with our company's Investigator Study Program Committee to evaluate outcomes research study protocols ... for studies in local markets Support our Manufacturing Division's affiliates to understand local needs, adapt health economic evaluations, customize Outcomes Research documents such as protocols and reimbursement dossier, which includes the development of the… more
- Catalent (Philadelphia, PA)
- …and SOPs related to batch record documentation and release.Act as lead investigator for all Problem Reports regarding batch record documentation and support Problem ... Reports led by Operations.Interact with customers regarding questions, issues, metrics, batch records, etc; Respond to and investigate customer complaints.Audit for compliance as pertains to Catalent SOPs, regulatory, & customer requirements.Perform all… more
- Eisai, Inc (Nutley, NJ)
- …advisory boards, health outcomes plans, MSL activities, speaker programs, investigator -initiated research and CME grant reviews or other internal key ... business processes.Continuously ensures compliance with Eisai policies and procedures for all activities undertaken and monitors various government and industry guidelines to best practices. Requirements This position requires a dynamic individual with a PhD… more
- Aequor (Thousand Oaks, CA)
- …of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed ... Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans Conduct the formal review and approval of authored documents, following applicable standard… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Clinical study protocols and protocol amendments Clinical study reports (CSR) Investigator brochures (IB) Deliverables for meetings with Regulatory Agencies (meeting ... requests, briefing books, slides, minutes) Responses to requests from regulatory agencies and ethics committees Pediatric investigational plans (PIP) Orphan Drug applications Breakthrough Therapy Designation requests Mentoring, Process Improvement, and… more
- Merck & Co. (North Wales, PA)
- …trial level plans/timelines, country/site selection, site materials, system updates, investigator meeting planning, communication plans, preparation of status update ... reports, study close out activities).Leads team for timeline management, risk identification and mitigation, issue resolution.May facilitate and collaborate with key internal/external stakeholders (eg, study team, country teams, vendors, committees) in support… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …include: Clinical study protocols and protocol amendments Clinical study reports (CSR) Investigator brochures (IB) Informed consent and assent forms Lay summaries of ... clinical trial results Clinical evaluation plans (CEP) and clinical evaluation reports (CER) Pediatric investigational plans (PIP) Orphan Drug applications Breakthrough Therapy Designation requests Clinical summary and overview documents in eCTD format for… 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 ... submissions, and responses to questions from regulatory authority or EC/IRBs.Provide medical feedback for activities related to review of data for interim analysis or blinded data reviews.Production of tables, listings and narratives of safety areas of… more
