- Merck & Co. (Rahway, NJ)
- …( as a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ... development teams and the operational/executional arms within the business.-- - - The Program Clinical Supplies Project Manager ( Program CSPM) serves as the… more
- Merck & Co. (Rahway, NJ)
- …availability of Clinical Supplies and Development Batches to meet Clinical Development Program requirements. This will require routine interaction with ... Job DescriptionThis Senior Engineer position will provide engineering support to...of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS)The FLEx sterile facility supports the formulation… more
- Merck & Co. (Rahway, NJ)
- …technical responsibility and leadership of internal and external work.The Senior Scientist, Engineering position leverages scientific/technical experience to develop ... -The candidate will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments.… more
- Merck & Co. (Rahway, NJ)
- …projects under supervision in Late Development Statistics. --Interacts with Clinical , Regulatory, Statistical Programming, Data Management and other company Research ... Laboratories Scientists in designing and analyzing clinical trials, and in coordinating the statistical...to ensure that the data evaluated are in high quality and satisfy analysis requirements.Collaborates with the statistical programming… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …cutting-edge AI/GenAI technologies and developing AI/GenAI products to deliver high quality insights with speed and efficiency Promotes a culture of creativity ... ED&AA, IT, Ethics and Compliance, Commercial, Patient Services, CMR ( Clinical , Medical, Regulatory), Finance, and Novo Nordisk global colleagues. Externally,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Operations, including but not limited to - Commercial, Patient Services, CMR ( Clinical , Medical, Regulatory), Finance, and Novo Nordisk global colleagues, to deliver ... and rotations.Demonstrate analytics' value in solving complex business challenges.Engage senior leaders to drive strategic analytics transformations.Partner with Data… more
- Merck & Co. (North Wales, PA)
- …: This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more ... tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.… more
- Merck & Co. (Rahway, NJ)
- …solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory, Operations, Non- clinical , Clinical , and other ... fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of.../ our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to ensure timebound… more
- Merck & Co. (North Wales, PA)
- …with senior cross-functional leadership to optimize efficiencies in the clinical development space. Preferred skills include experience in the application of AI, ... President in BARDS and will work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs.--The AVP provides leadership and direction… more
- Merck & Co. (Rahway, NJ)
- …statistical analysis and reporting deliverables under the guidance of a senior -level programmer supporting early-phase oncology clinical trials. Collaborate with ... and program text files for regulatory submission. Assure high quality and timely deliverables. Communicate and collaborate effectively with project team… more
- Merck & Co. (Rahway, NJ)
- …upstream and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and commercial ... program progress, issues, and mitigation plans to the senior management.Innovative mind-set demonstrated by technical accomplishments, external presentations, and… more
- Merck & Co. (Rahway, NJ)
- …to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's Research Laboratories (Research & Development) ... efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders creating optimal development, commercialization, and… more
- Merck & Co. (Rahway, NJ)
- …at its Rahway, New Jersey research facility. The Principal Scientist is a senior scientific role tasked with working closely with the group Director to define ... (separation-based and residuals) and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …methodologies to provide key insights into the biopharmaceutical landscape across clinical , commercial, and enterprise domains. This role involves applying data ... Sales operations, Market Access and Public Affairs, and enterprise function's clinical and business decision-making is supported by timely, accurate and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …consistency with brand/therapy area vision and message. Relationships Reports to Senior Director of Cardio Renal Marketing Responsible for providing interface with ... Proven knowledge of the pharmaceutical industry, including medical, regulatory, clinical processes and market dynamics, especially within specified therapy area… more
- Merck & Co. (Rahway, NJ)
- …listings, figures and submission deliverables under the guidance of a senior level programmer.Perform validation tasks according to departmental SOPs and collaborate ... transport files and associated documentation for regulatory submissions.Assure deliverable quality and compliance with departmental SOPs and good programming… more
- BioSpace (San Francisco, CA)
- …chapter with a new script to outmatch disease. Responsibilities and Duties: The Senior Manager/Associate Director of Clinical Quality Assurance Auditor is ... partnering with cross functional teams to manage the audit program and conducting audits (routine & for-cause clinical...senior management, as appropriate Act as the lead Clinical Quality assurance point of contact with… more
- Planet Pharma (Plainsboro, NJ)
- …the implementation of the global development strategy, leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds in various ... stages of clinical development (eg clinical trial implementation), and...with the Medical Director and other cross-functions to provide high- quality and timely deliverables -Contribute to the development of… more
- Kymera Therapeutics (Watertown, MA)
- …our people are valued, seen, and heard. How you'll make an impact: The Senior Director, Clinical Operations is a leadership role responsible for overseeing and ... managing all aspects of clinical operations for a high priority immunology program...with multiple studies and indications through all phases of clinical trials (Phase I-III). The Senior Director… more
