- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a full-time permanent Director / Senior Director , Clinical Quality Assurance. This is a ... hybrid position. Job Title commensurate with experience.SUMMARY:Reporting to the Chief Quality Officer the Senior Director of Clinical Quality Assurance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, ... drug products consistent with the company goals; specifically, for the life-cycle management of NDAs/BLAs. This individual will be responsible for working on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director , Program Management is a senior position responsible for ... project level quality metrics. An ideal Associate Director , Program Management must have the expertise...and tools for program and project performance reporting to senior business and IT management in an… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …this leader enables all activities related to the successful acquisition of high- quality goods/services at the best possible prices and business terms for NNI. ... and Marketing organization Leads a team that goes beyond traditional category management functions with a significant focus on business partnership and driving value… more
- Merck & Co. (Millsboro, DE)
- …DNREC, etc.) of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report to the Site Quality Head/ ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...all federal and state regulatory requirements for animal welfare, management of controlled substances, quality control testing… more
- Merck & Co. (Rahway, NJ)
- …and manage the change required to execute.Ability to work with senior management with professionalism and discretion.#EBRG#VETjobsNOTICE FOR INTERNAL ... Job DescriptionThe Director of Business Systems and Process Improvement leads...and continuous improvement initiatives within Animal Health Global Supplier Management (AH-GSM). This role also manages global procurement systems… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …helping to develop and deliver processes, training, procurement technology and knowledge management tools. Closely partners with senior Business stakeholders to ... management , supplier diversity required- Proven experience working with senior leadership, including C-suite executives preferred- Possess an understanding of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) ... CS Group Lead will also ensure the writing of high- quality clinical trial protocols, review of clinical data and...to Group Heads in Clinical Development, Asset & Portfolio Management , Global Clinical Operations, BDM and DLT members. He/she… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to exercise ... influence at the senior leadership and/ or executive level wherever GLP/non-GLP/ research...plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents supporting GLP/non-GLP/ Research… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …decision-makers across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions ... Global Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of both worlds to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …communication between CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL ... Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population...clinical trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to budget, timeline, achievement of defined milestones and overall project risk management . He/she will assess project issues and develop resolutions to meet smooth ... transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to internal and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key ... include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management , Biostatistics, Non-clinical, Medical Affairs, Marketing, Legal, Quality ,… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key ... written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… more
- Novo Nordisk Inc. (Boulder, CO)
- …small molecules and oligonucleotide products. Relationships This position reports to Senior Director , Chemical Development. Essential Functions Lead the ... to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our… more
- Merck & Co. (Rahway, NJ)
- …similar)Required Experience and Skills:10+ years biotech/pharmaceutical industry experienceProject management skills; focus on quality and ... results, document disclosure, and data sharing with external researchers. The Executive Director in Medical Writing will be responsible for overseeing clinical trial… more
- Merck & Co. (Rahway, NJ)
- …of technical experience; competence in clear concise and tactful communication with senior management , clients, peers and team members Demonstrates an executive ... and technologies.- They will lead the Technology Integration Meeting and provide Senior Technology approvals in the Design Authority.- They will ensure the smooth… more
- Merck & Co. (Rahway, NJ)
- …Owner collaborates with stakeholders across all levels of the organization, from senior management to tactical execution- to understand customer master data ... focused on meeting business needs and maximizing value for investments.Organizational Change Management : Demonstrate and drive high- quality change management … more
