- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Associate Director , GMP QA Process Excellence is accountable to collect ... information, analyze quality related process, define strategies to lead to the...strategies to lead to the development and implementation of quality improvement initiatives across the organization.This role will focus… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for ... Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes Processes and Best Practices: Reinforces labeling best ... practices at cross-functional meetings. Assists in the development of Standard Operating Procedures (SOPs) and process improvements. Follows agreements with external partners.Department Coordination: Builds cross-functional and cross-regional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of statistical activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides input to multiple aspects of the ... development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.- CRO / Vendor Oversight: Review CRO/vendor proposal and budget.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior ... CMC Lead regarding the activity status and potential critical issues, or to the governance bodies. Responsibilities - Accountability to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case no Sr CMC Lead is established, take… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking Associate Technical Lead as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Associate Technical Lead will ... Responsibilities This individual with provide direct support to the Director of Manufacturing Excellence by providing technical expertise to Technical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Manager role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This ... primary accountability for operational study level time, cost and quality deliverables.Lead the development of the clinical study plan...share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis and ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assignment and oversight of the group. This position reports to the Associate Director Data Management Operations. Business administration activities within the ... and maintaining new SOPs, Work instructions, templates, and other quality documents.Responsibilities:Leadership, Direction, and Strategy: Establish and manage accountability… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Associate Global Medical Director will serve as a pivotal leader in advancing the ... Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …human-centered design pull you in? Are you ready to experiment with us? 5 Associate Director - Launch Excellence positions open in the following TA: Obesity, ... CV/Renal, Diabetes, Emerging, and Rare Disease. The Position The Associate Director - Launch Excellence will play...planning and organizational skills with exceptionally high attention to quality of detail and proven track record of results… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Research Partnerships (RP) is responsible for developing and executing ... alignment with the Evidence Generation Plan (EGP). Externally, the Associate Director RP will be the lead...RWE generation and dissemination through research partnerships Ensure the quality and validity of real-world evidence and ensure that… more
- Genmab (Plainsboro, NJ)
- …responsible for managing the key area of field force incentive compensation. The Associate Director of Field Operations - Incentive Compensation works closely ... process from design and implementation to payouts and leadership updates. The Associate Director of Field Operations - Incentive Compensation will report… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions Provide strategic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …managed elsewhere internally or at vendors. Relationships Reports to the Senior Director , Advanced Analytics & Innovation. Works closely across the entire NNI ... to derive insights Comfort operating in a fast-paced, environment, with a quality control focus and a documentation orientation Creative problem-solving with ability… more
- Merck & Co. (Rahway, NJ)
- …a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ,- strategies and ... software . - Familiarity with Good Manufacturing Practices (GMP) requirements, quality procedures, and Standard Operating Procedure (SOP) execution. - GCSCareer25… more
- Merck & Co. (Rahway, NJ)
- …journey to become the premier "Data First" commercial biopharma organization.In this Associate Director Data Product Management role, you will be part ... a plusTranslate use cases into implementation roadmaps to deliver high quality data productsEstablish common performance expectations and processes for data product… more
- Merck & Co. (Rahway, NJ)
- …CSS team with IS&O initiatives and daily operations, adopting high- quality change practices and embodying our Companys Enterprise Leadership Skills.Stakeholder ... trust through effective communication and relationship management.Execution Excellence: Deliver high- quality outputs within deadlines while navigating ambiguity.Business and Technology… more
- Merck & Co. (Rahway, NJ)
- …creative and innovative real estate and workplace solutions aligned with corporate strategy.The Associate Director of Real Estate Strategic Planning will play a ... skills and meticulous attention to detail, with a commitment to delivering high- quality work.Leadership experience with a demonstrated ability to mentor and guide… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director of Scientific Nomenclature and Reference Data is responsible for assigning accurate chemical nomenclature to small ... scientific background, excellent communications skills, and project management skills to derive high- quality reference data to meet the diverse needs of the business… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Corporate Accounting guidelines in accordance with IFRS regulations. Relationships Reports to the Associate Director of Accounting at Novo Nordisk Inc. As part ... Provide monthly status reports on closing process to the Associate Director of Accounting, the Senior ...what it takes mindset and positive attitude Commitment to Quality - dedicated to providing the highest quality… more
