- Daiichi Sankyo, Inc. (Bernards, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... the company's growth, thereby accomplishing corporate goals.ResponsibilitiesDevelop and implement US regulatory strategy for assigned project(s).Strategize and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, ... Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions Serve as ... human health starts here and that patients rely on us . We're changing lives for a living. Are you...Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational… more
- Merck & Co. (Rahway, NJ)
- Job Description Position Description: Associate Director , Site Services Procurement (NORAM) This Procurement Associate Director role will be a member of ... the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a… more
- Merck & Co. (Rahway, NJ)
- …the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a ... regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre-clinical and translational work for… more
- Merck & Co. (Rahway, NJ)
- …safe, sustainable and healthy future for people and communities everywhere.The role of Associate Director , ESG Strategic Reporting is a unique opportunity to ... the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a… more
- Merck & Co. (Rahway, NJ)
- …the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. The Associate Director , HCP Marketing is responsible for developing and implementing strategic ... employers to electronically verify the employment eligibility of all new hires in the United States . Please click on the following link for more information:… more
- Tris Pharma (Monmouth Junction, NJ)
- …Administration (FDA) guidance and provides technical guidance within and outside R&D for regulatory and quality matters.The Associate Director / Director , ... Associate Director / Director , Analytical Research...(www.trispharma.com) is a leading privately-owned biopharmaceutical company in the US with a focus on development and commercialization of… more
- Merck & Co. (Rahway, NJ)
- …assigned accounts.- The Senior Consolidation Accountant reports directly to the Associate Director of Consolidation Accounting.Primary responsibilities for this ... quality of the financial information provided to investors and regulatory bodies, and the relevance of the financial information...in certain states and cities within the United States . Final determinations with respect to… more
- Merck & Co. (Rahway, NJ)
- …Dosage (Non-Sterile) team at the FLEx Center in Rahway is looking for an Associate Director - Process Engineer to lead clinical supply manufacturing, scientific ... a learning environment and monitoring progress of growth.Familiarity with US and EU GMP and Safety compliance regulations.Desire and...in certain states and cities within the United States . Final determinations with respect to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... CMC regulatory compliance activities for portfolio biologics to meet US , International Conference on Harmonization (ICH), and other applicable regulations. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary: The Associate Director , Regional Marketing Conventions & Field Programs will be ... while ensuring adherence to DS policies and procedures. The Associate Director , Regional Marketing Conventions & Field...managing the execution of National & Regional Conventions for US brands & Regional Marketing team. This position will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Leads US FDA/EU EMA interactions with support from higher-level manager. Regulatory Knowledge: Demonstrates expert knowledge of US /EU regulatory ... contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC...as the company liaison with the Health Authority (eg, US FDA and EU EMA) for assigned projects with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …programs to support the business functions of Daiichi Sankyo (DS) in the US , EU, Japan, and other global sites. These business functions include: Clinical ... Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, … more
- Tris Pharma (Monmouth Junction, NJ)
- …have an immediate opening in our Monmouth Junction, NJ facility for an Associate Director , Alliance Management.Tris Pharma has a long track record of ... spanning many departments across all stages of the product lifecycle. The Associate Director , Alliance Management will be accountable for managing alliances… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key internal ... We recognize that improving human health starts here and that patients rely on us . Our R&D hub merges biotech speed and agility with large pharmaceutical company… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Global RD and PV QA organizational strategy in collaboration with the Associate Director Global Strategy and Operations and Head Global Strategy and ... drive the global QA vision and act as the US QA point person for Strategy & Operations. This...Operations. In collaboration with the Associate Director Global Strategy and Operations and… more
- Sun Pharmaceutical Industries, Inc. (Jamesburg, NJ)
- Associate Director , Clinical Operations Sun Pharma Advanced Research Company Limited Princeton, New Jersey Summary The Associate Director , Clinical ... New Jersey Responsibilities Assigned: Oversee and manage all operational aspects of phase I-IV US based or global clinical trials Act as primary point of contact for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …other safety information for all Novo Nordisk products. Relationships Reports to Associate Director , Patient Safety Training. Internal relationships include all ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… more
