- Merck & Co. (Rahway, NJ)
- …quality data from clinical trials conducted worldwide. In partnership with the Clinical Quality Operations Lead (CQOL) and Head of Clinical Quality ... new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations team ... based in Raritan, New Jersey. Role Overview The Quality Systems Lead role is an exempt level position with responsibilities for supporting the quality … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and LeadershipHas primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan ... and execution (from planning start-up, conduct, reporting and close out) including timeline, quality and budget. A key focus will be the oversight of and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …& Leadership Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan ... for assigned clinical study (-ies) utilizing Microsoft Project or equivalent. Lead the creation of the cross-functional Clinical Study Oversight Plan… more
- Insmed Incorporated (Bridgewater, NJ)
- …in Design Control Process for medical device products and combination products. Lead the quality assessment for product lifecycle changes, efficiency ... York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director, Quality Operations will play… more
- Merck & Co. (Rahway, NJ)
- …medical device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- ... products and processes are developed in accordance with applicable regulatory, quality , company, and customer requirements.-This position will lead … more
- Novo Nordisk Inc. (West Lebanon, IN)
- …stand alone during regulatory inspection through close collaboration with Operations and Quality teams Lead cross-functional investigation teams to identify root ... collecting necessary data and information associated with operational deviations. Will lead and facilitate root cause analysis investigations with site personnel and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the global regulatory strategy for assigned programs to ensure timely and high- quality regulatory deliverables to the GPTs Lead health authority interactions, ... merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of...wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute… more
- Aequor (Seattle, WA)
- …multiple sources and conduct data verification processes to ensure accuracy and integrity. Lead quality system document review and routing. Follow up with ... to ensure rapid, flawless, compliant, and cost-effective delivery of quality products. The role will benefit from a strong...Analyst is closely partnered with the Technical Product Team Lead and Stewards to enable effective execution of strategy… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The HCP Experience Lead will play a critical role in ensuring the successful execution of brand/therapy ... and monitors adherence to administrative policies and procedures. The HCP experience lead has a team reporting to them potentially inclusive of hcp experience… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to global Development governance. In this key role, the candidate will have to lead a complex, global team in charge of a global clinical program designed to ... representative of asset through the lifecycle from research to post-marketing functions. Lead all GPT meetings, ensure team and cross functional alignment, positive… more
- Merck & Co. (Rahway, NJ)
- …degree of technical, project, and people management responsibility. - This SSO Facility Lead role within the SSO Pilot Plant leverages significant depth and breadth ... of scientific, technical, and operational experience to lead and support facility operations, process development activities, compliance investigations/change… more
- Merck & Co. (Durham, NC)
- …our patients. We work in the manufacturing plants with a "Safety First, Quality Always" mindset, striving for continuous improvement, and earn our right to produce. ... local plants connected to our global manufacturing network supplying the highest quality of raw materials, intermediates, and finished products.This role is within a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you ready to experiment with us? The Position The Business Performance Management Lead will play a pivotal role in defining and standardizing core Key Performance ... across the Commercial Strategy & Marketing (CS&M) organization. This role will lead efforts to determine the most relevant metrics to measure business performance,… more
- Merck & Co. (Rahway, NJ)
- …of the Research & Development division.The Associate Director, PMO People & Process Lead , is a unique role that will be heavily client-facing, accountable for ... the training forum; accountable for curating and defining a quality annual calendar of topics that achieve the purpose...for our community of clients that grows over time.Delivery lead for PMO Project Management onboarding training and PMO… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The Business Excellence Lead will play a pivotal role in guiding the Commercial Strategy and Marketing (CS&M) ... and align on major milestones and business reporting requirements. The Business Excellence Lead has a team reporting to them potentially inclusive of an operations &… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to experiment with us? The Position The HCP / KOL Strategy lead will be a pivotal driver in shaping an insights-driven HCP marketing strategy and KOL ... KOL engagements, and strategies. The HCP / KOL strategy lead has a team of HCP and KOL strategists...planning and organizational skills with exceptionally high attention to quality of detail and proven track record of results… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with delivery lead eg review TLG before ... strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader (ITL-ISTL)ResponsibilitiesStudy Strategy: For Phase 2… more
- Eisai, Inc (Nutley, NJ)
- …incidents.Conduct annual tests and address vulnerabilities.Analyze threat data and lead hunting efforts.Deploy standards, conduct training, and track KPIs.Define ... emerging technologies applicable to pharma and biotech.Problem-solving ability considering quality , cost, and speed.Broad understanding of IT technology platforms,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to experiment with us? The Position The Diagnostics and Precision Health Lead will be responsible for developing and implementing a diagnostics and precision ... to finding patients. Relationships Reports to Integrated TA Strategy Lead . Collaborates closely with cross-functional teams, including therapy area marketing… more
