- 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
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Associate Director , Clinical Programming must have expertise in addressing technical ... will be responsible for implementing new technological solutions for end users.The Associate Director , Clinical Programming manages and oversees JReview… 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)
- …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)
- …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)
- …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
- 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 (Madison, 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
- 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
- AbbVie (Florham Park, NJ)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Statistics - Eye Care provides statistical leadership ... for clinical development and life-cycle management strategies for assigned projects....trials, patient safety, and global medical affairs (GMA). The Associate Director works in partnership with experts… more
- Bristol Myers Squibb (Madison, NJ)
- …their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Associate Director of WW Medical Neuroscience, Neuro degeneration ... global medical stakeholders. This position reports to the Senior Director , WW Medical Neuroscience, Neuro degeneration Medical Strategy. **Key Responsibilities**… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …for staff recruitment, development, coaching, mentoring, and performance management. **As an Associate Director , CDM Lead, a typical day might include:** + ... vendors, teamwork partners and clinical study personnel for clinical research project and department initiatives. The PDML may be responsible for line… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …aspirations. Join Gilead and help create possible, together. **Job Description** The ** Associate Director , USMA Strategic Execution** will play a critical role ... other functional areas where needed. + Foster stakeholders' understanding of project aims and inherent risks during initial development, shape their expectations… more
- Bristol Myers Squibb (Madison, NJ)
- …lives. Read more: careers.bms.com/working-with-us . Position reports to the Director of Medical Communications within Worldwide Medical Oncology (Hematology), Global ... aligned medical communications plans; adjust communications plans in accordance with clinical trial results/milestones and changes in the healthcare landscape +… more
- Bristol Myers Squibb (Summit, NJ)
- …their personal lives. Read more: careers.bms.com/working-with-us . The primary purpose of the Associate Director , Cell Therapy - Direct Materials role will be to ... category management, process redesign and continuous improvement expertise , project management and performance measurement skills. + Procurement process knowledge,… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** As Regulatory Affairs Associate Director , you will be responsible for leading RA team members involved in device project ... + Comprehensive knowledge of US medical device regulations (FDA), Clinical Practice standards, Laboratory Practice regulations, and Quality System Regulations.… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Process Engineer will be expected to facilitate workshops, fact-finding interviews, project management activities, and other necessary activities to gather and ... + Advanced skill level in Microsoft Word, PowerPoint and Excel + Experience with project management approaches and tools with specific experience with MS Project … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …other programs. You will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on cross-functional core and ... leaders and teams. + May participate on other Sub-teams (eg, Study Management, Clinical , Nonclinical, Biomarkers) or assign such to other colleagues and oversee and… more
- Bristol Myers Squibb (Summit, NJ)
- …Processes across the manufacturing network throughout the product life-cycle from pre- clinical through commercial manufacturing. The Sr. Principal Engineer will be ... verification. The role collaborates across all CMC functional areas to ensure project advancement, rapid and best in class execution, and communication of… more
