- Merck & Co. (Rahway, NJ)
- …a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology we collaborate to discover and develop the next medical ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… 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 rigor of processes, and ultimately to enable flexibility...communication skills, both verbal and written. Education Minimum Requirements: Associate 's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible ... science and technology. With more than 120 years of scientific expertise and a presence in more than 20...and strategic insights at the study team level. The Associate Director of Regulatory Writing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Associate Director of Regulatory Writing is a key role ... science and technology. With more than 125 years of scientific expertise and a presence in more than 20...and strategic insights at the study team level. The Associate Director of Regulatory Writing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director Immuno-Oncology as part of the Research and Development ... cell-based therapies. We are seeking an experienced and dynamic Associate Director to lead our in vivo...The candidate needs to demonstrate the ability of delivering scientific results with integrity and meeting timeline, show the… 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 ... by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... projects assigned to individuals are current and up to date- Support regulatory inspection related activities as required- Support Head, Global strategy and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of ... science and technology. With more than 120 years of scientific expertise and a presence in more than 20...as well as alliance partners, promoting a cohesive team approach. Regulatory and Safety Compliance: Understand study conduct from supply… 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 ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...while ensuring adherence to DS policies and procedures. The Associate Director , Regional Marketing Conventions & Field… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... and manages multiple Companion Diagnostics Partnerships with Diagnostic PartnerProvides scientific and technical expertise by collaborating closely with Translational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans,… 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...per project priorities. She/he also reviews and approves all scientific , technical and regulatory packages per International… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for oncology… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... Demonstrates strong knowledge of the industry, vendor base, and regulatory issues for respective categories. Leads the development of sourcing… 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
