- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Experience Qualifications 7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development or ... authoring, and management of Dose Preparation Instructions in support of clinical studies being conducted globally by Daiichi Sankyo. The candidate will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams.Responsibilities: Study Strategy: Provides the ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...and oversee completion of clinical trial protocols. Provides… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of a CDx study/IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data is ready for CDx submission (after ... to external diagnostic business partners specifically:Use of CTA/CDx within clinical trialsDevice protocols and SAPsDevice non-significant/significant risk determinations (both… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves ... as ad hoc member to the Global Project Team for late stage projects. This position manages...technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …this job is to provide statistical programming technical support to DSI project teams on all statistical programming deliverables and programming submission. It will ... and build up standard on SDTM/ADaM datasets, and TFLs.Responsibilities:- Supporting project lead on outsourced projects, act as statistical programming subject… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is accountable ... QA RDPVQA, and oversees multiple levels of direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global Quality teams… more
- Merck & Co. (Rahway, NJ)
- … Management Office (PMO); and Administrative Professionals. Position Description/Summary: The GPAM Associate Director , Value & Implementation Project Manager ... the R&D pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive cross-functional… more
- Merck & Co. (Rahway, NJ)
- …to manage clinical development projects; and assist the Executive Director and/or Associate Vice President in ensuring that appropriate Corporate ... Atherosclerosis & Metabolism medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the entire… more
- Merck & Co. (Rahway, NJ)
- …individuals who are passionate about driving impactful changes. Position Overview: As the Associate Director of Launch Strategy and Operations, you will lead the ... IndicatedValid Driving License:NoHazardous Material(s):n/aRequired Skills:Adaptability, Adaptability, Agile Methodology, Agile Project Management, Biopharmaceuticals, Biotechnology, Business, Clinical Immunology,… more
- Merck & Co. (Rahway, NJ)
- Job Description Associate Director , Clinical Supply Operations (P4) Position Description The Associate Director , Clinical Supply Operations (CSO) ... all while supporting our commitment to business continuity.Key responsibilities of the Associate Director , Clinical Supply Operations include:Supporting the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …improving the lives of more patients than ever before. The Position The Associate Director , Rare Bleeding Health Care Professional Marketing Experience has ... functionally with multiple functions and groups throughout the US organization, Clinical Development, Research & Early Development, other affiliates, and the Global… more
- Merck & Co. (Rahway, NJ)
- …of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility for this position is to ensure ... identified regulatory updates.Audit vendors/partners of SaMD/IVD/Companion DiagnosticsReports to - Director Regulatory Compliance, Device Quality and RegulatoryLocation - Remote,… more
- Merck & Co. (Rahway, NJ)
- …trials and will interact externally with key opinion leaders.-Specifically, the Executive Director , PDT lead may be responsible for:-Evaluating pre- clinical and ... of external opportunities.-Provide support for other therapeutic areas regarding clinical issues related to oncology compounds.-The Executive Director /PDT… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for marketed products Track applications through FDA reviewing divisions Work with project associate on compilation of information and supportive documentation ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...Position Manage and oversee all assigned projects/products/processes. Assist the Director in assuring Novo Nordisk compliance with internal SOPs… more
- IQVIA (Parsippany, NJ)
- *Home-based position Our Associate Directors in Clinical Project Management manage and support the operational elements and execution of studies and/or ... in life sciences or related field with 10 years clinical research experience and 5-7 years global project... clinical research experience and 5-7 years global project management experience + In-depth therapeutic knowledge in one… more
- Bristol Myers Squibb (Princeton, NJ)
- …report into Director , Clinical Data Management or Associate Director , Clinical Data Management. ** Project Management and Leadership** * Provides ... in their personal lives. Read more: careers.bms.com/working-with-us . The Senior Manager, Clinical Data Management is a leadership role considered essential to the… more
- Merck (Rahway, NJ)
- …Management Office (PMO); and Administrative Professionals. **Position Description/Summary:** The GPAM Associate Director , Value & Implementation Project ... the R&D pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive cross-functional… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Position:** Associate Director , Master Project Scheduler (Americas) **Location** ... : New Brunswick, NJ; Lawrenceville, NJ; or Devens, MA **Position Summary:** The Associate Director , Master Project Scheduler (Americas) is a critical… more
- Bristol Myers Squibb (Princeton, NJ)
- …$160,000-$190,000, plus incentive cash and stock opportunities (based on eligibility). + For Associate Director level, the starting compensation for this job is ... therapeutic areas. The ideal candidate will support early and late-stage clinical drug development across therapeutic areas by leveraging Quantitative Systems… more
- IQVIA (Parsippany, NJ)
- …guide and inform the monthly investigator payment forecast cycle and support project finance requirements, including a review of accruals, costs incurred, contracts ... focus. + Proven record of results working with senior management. + Strong project management skills and the ability to translate business challenges into financial… more
