- Merck & Co. (Rahway, NJ)
- … Development Associate Principal Scientist - Device Engineering and Early Development Lead (Associate Director Equivalent)Our company's Device Development ... the drug delivery and combination produce space to:Drive pipeline development . Lead the core engineering technical device...development team(s) supporting individual drug assets currently in clinical development with line of sight to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a key member of the General Medicine Global Clinical Development team, the Vice President/ Therapeutic Area (TA) Head's primary objectives will ... design and monitoring of clinical programs and studies, producing high- quality clinical documents and presentations.Collaborate with functional area leaders… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including ... and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and...Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO, 3rd… more
- Merck & Co. (North Wales, PA)
- … Clinical Safety StatisticsInteract with Safety Physicians, Safety Scientists, Clinical Trial Physicians , Regulatory, Early/Late Development Statistics, ... and statistical analysis methods fundamental to effective pharmaceutical R&D.- The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader ... Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with delivery lead eg review TLG before DBL,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …sections of submission documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member with ... support to the CSL and Medical Monitor in the execution of Clinical Development functions.ResponsibilitiesStudy Strategy: Drafts development plan under… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a key member of the Global Product Team in collaboration with Clinical Development , Regulatory, Project Management, Biostatistics, Pharmacology, and other ... as other research areas centered around rare diseases and immune disorders. Summary The Director, Clinical Safety, will be a product safety lead or part of a… more
- Eisai, Inc (NJ)
- …provider business relationships in alignment with global strategies.Review and approve Clinical Quality Assurance audit plans and reports.Review and respond ... a good understanding of other IT systems for contract management and clinical development .#LI-TS1Eisai Salary Transparency Language:The base salary range for the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Job SummaryThis position is responsible for clinical label development support for all Daiichi-Sankyo led clinical ... design of clinical labels.Role Responsibilities- Manage end to end label development process for assigned projects / clinical studies in close collaboration… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before ... trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development ...Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and ensure compliance and highest quality standards in all GOMA clinical operational activities. Support the development of clinical operations ... disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality...activities and expectations. Ensure regular updates provided to Study Lead on trial metrics, data, and quality .Establish… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director, Clinical ... into CDP planning and individual protocols to facilitate successful implementation of programs. Clinical OperationsEnsure high quality delivery of all studies for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The Brand Strategy Lead is pivotal in developing brand level objectives and strategic priorities. They will ... overall brand growth, market share and profitability as well as supporting the development and execution of the marketing strategies to promote brand in alignment to… more
- Merck & Co. (Rahway, NJ)
- …of capital project delivery for facilities and laboratories in the pilot/ development /commercialization space. -Collaborate with manufacturing, quality and supply ... enablement of late-stage drug substance and product (LM/SM/Vaccine), process development , product introduction, commercialization, and Manufacturing ( clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clear and sustainable platform of evidence generation, design and leadership of clinical development plans, and addressing all regulatory, drug and patient ... Global R&D organization. At Daiichi Sankyo, the engine of development is the cross functional, empowered and agile Global...In this key role, the candidate will have to lead a complex, global team in charge of a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …tactics and market shaping initiatives including but not limited to KOL development , advisory boards, clinical communications and medical education programs ... member of Mature Business Unit Leadership Team responsible for directing the development and execution of the commercial marketing strategy, inclusive of payer… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development . We are building for the future, creating a distinct ... advise on development strategies, and deliver on associated regulatory activities Lead the Global Regulatory Matrixed Team in defining and executing the global… more
- Catalent (St. Petersburg, FL)
- …and the quality teams globally during the management of supplier quality issues Lead and support Supplier issues / investigations affecting Catalent ... Quality Auditor Position Summary: Catalent is a global,...of all sizes to advance new medicines from early development to clinical trials and to the… more
- Catalent (Philadelphia, PA)
- …and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than ... a QA Supervisor. The QA Supervisor will p rovide Quality Assurance support for the Quality Inspectors...a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …programs.Help to ensure in collaboration with Global Development Operations (GDO) (Global Clinical Operations / Clinical Quality Management or other RD ... research areas centered around rare diseases and immune disorders.Summary Lead the implementation of the quality strategy...business process owners that applicable clinical development processes and quality … more
