- 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)
- …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
- 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
- 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
- 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. (South San Francisco, CA)
- …to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be an experienced pharmacometrician with a strong, ... and Simulation (M&S) tools in decision making to drive pipeline impact. The Senior Director will take on primary responsibilities for identifying emerging areas of… 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)
- …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
- 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
- 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
- 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
- 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
- Glycomine (Boston, MA)
- …by a genetic mutation that disrupts the function of an important enzyme. Glycomine's lead clinical program in PMM2-CDG aims to deliver a substrate to bypass the ... life for patients, caregivers, and families. Job Description The Senior Clinical Project Manager/ Clinical Project... programs. You'll provide support and experience to the program and members of our Clinical Development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Proven knowledge of the pharmaceutical industry, including medical, regulatory, clinical processes and market dynamics, especially within identified therapy area ... metrics/ROI) Outstanding planning and organizational skills with exceptionally high attention to quality of detail and proven track record of results and follow-up… more
- Eikon Therapeutics (Millbrae, CA)
- …throughout the clinical trial process. What You'll Do In collaboration with senior clinical operations management, build and lead inhouse clinical ... clinical trial audits, working closely with the Clinical Quality Assurance group. Represent Clinical...and develop, coach, and retain top talent in the clinical program team. Sets clear performance standards… more
- Medical Mutual (Cleveland, OH)
- …provide peace of mind to more than 1.2 million members through our high- quality health, life, disability, dental, vision and indemnity plans. We offer fully insured ... individual plans. Builds and sustains long-term partnerships with key clinical vendors, overseeing substantial financial investments. Understands vendor capabilities,… more
