- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Director - Epidemiology leads the development and execution of observational research studies ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...RWE studies performed with external data sources. Additionally, the Director - Epidemiology is responsible for the execution… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …& Organization team. Our P&O team is passionate about their purpose - enabling business success the Novo Nordisk Way by turning the Company's business strategy ... for remote/in office dedicated time. EST time-zone hours. The Position The Director , Diversity, Equity, Inclusion & Belonging (DEI&B) plays a pivotal role in… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director of Method Development & Testing is responsible for leading a Center of Excellence (CoE) focused on developing and validating ... role involves leading the method tech transfer strategy and execution to internal and external GMP testing nodes in...support of clinical and PPQ supplies. Additionally, the Associate Director leads, manages, and develops a team responsible for… more
- Eisai, Inc (Nutley, NJ)
- …information assets.Purpose of role:Oversee IT compliance initiatives (strategic and execution ).Assess and guide on compliance with regulatory , organizational, ... training and awareness programs. Business Continuity: Develop plans to mitigate business interruption risks.Change Management: Create a regulatory / non-… more
- Merck & Co. (North Wales, PA)
- …cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director ... dedicated colleagues while developing and expanding your career.The Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the planning… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to coordinate the execution of the long-term strategy, defining a sustainable business model in US beyond a 5-year time horizon. This department serves as the ... therapeutic areas, new products in the pipeline, and products acquired through business development efforts in existing and new areas. The STARS team collaborates… more
- Merck & Co. (Rahway, NJ)
- …company is seeking a highly motivated candidate for the position of Director , Small Molecule Development within the Mixed Modalities, Sterile Product Development ... for parenteral drug products within the small molecule and synthetic modality pipeline.The Director will report to the Executive Director of Sterile Product… more
- Merck & Co. (Millsboro, DE)
- …with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract ... and patients on time, every time, across the globe.Under the direction of the Director of Quality, the Associate Director , Quality Control is responsible for… 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 ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Tris Pharma (Monmouth Junction, NJ)
- …(FDA) guidance and provides technical guidance within and outside R&D for regulatory and quality matters.The Associate Director / Director , AR&D serves ... Associate Director / Director , Analytical Research and DevelopmentMonmouth Junction,...Tris colleagues understand the criticality of operating a successful business and take pride in the company's success. But… more
- Merck & Co. (Rahway, NJ)
- …disease indications to pursue and subsequent study design, initiation, execution , monitoring, analysis, regulatory filing, and publication. Specifically, ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … execution , and management, including GCP, ICH guidelines, and regulatory requirements Leadership: Proven track record of leading and managing high-performing ... needs while considering innovative approaches to accelerate speed of execution . In this role being accountable for accomplishing the...measurements that are consistent with the priorities of the business , and that interim reviews are held so that… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Oncology Competitive Intelligence Director (Genitourinary Cancers) We are currently seeking an Oncology Competitive Intelligence ... Director specializing in Genitourinary Cancers (Prostate Cancer, Bladder Cancer, Renal Cell Carcinoma). This role is responsible for providing Competitive… more
- Merck & Co. (Rahway, NJ)
- … business needs, which can include impact of the external business , regulatory , and compliance environment. Promoting our company's scientific excellence ... Development (SMAR&D) group has an exciting opportunity for a Director role as GxP Strategic Lead based in Rahway,...you will be part of a team that supports execution of analytical methodologies to characterize and release raw… 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)
- …to review all congress initiatives, timelines and deadlines for content and execution .Project management to ensure all business -critical deadlines are met for ... areas centered around rare diseases and immune disorders.Summary: The Associate Director , Regional Marketing Conventions & Field Programs will be responsible for… more
- Merck & Co. (North Wales, PA)
- …as lead statistician in cross-functional teams for the strategic planning and execution for product development and worldwide regulatory submissions.Lead a team ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …at public relations agencies for the purpose of ensuring successful program execution . Relationships Reports to the Director , Commercial Communications. The ... to life through strategic communications that elevate our purpose, drive our business , foster our culture and enhance our reputation with patients, customers,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Collaborates with external KOLs to refine study plans; Prepares and participate in regulatory agency meetings, if applicableStudy planning and execution : As CSL ... Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation… more
