- 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 ... GMP testing nodes in support of clinical and PPQ supplies. Additionally, the Associate Director leads, manages, and develops a team responsible for providing… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Director , Process Engineer - Oral Solid Dosage, Clinical Manufacturing The Formulation, Laboratory, and ... Center is a multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in...the FLEx Center in Rahway is looking for an Associate Director - Process Engineer to lead… more
- Merck & Co. (Rahway, NJ)
- …molecule and synthetic modality pipeline.The Director will report to the Executive Director of Sterile Product Development - Mixed Modalities, and lead ... and inclusive work environment.Essential Knowledge, Duties & Responsibilities for the Director Include:Sterile drug product development concepts, tools,… more
- Merck & Co. (Rahway, NJ)
- …Company's drug product pipeline.- The FLEx Sterile Process Engineer at the Associate Director level serves as a technical subject matter expert in process ... product manufacturing processes.- Close partnership with colleagues from Sterile Product Development , Quality, Regulatory Affairs, Engineering, and Analytical… more
- Merck & Co. (Rahway, NJ)
- …and associated documentation.Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products ... release from our company to external agencies and investigators.Provides expert advice to Product Development Teams and subsidiaries on regulatory issues as they… more
- Merck & Co. (Rahway, NJ)
- …and associated documentation. Provides expertise as Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products ... product labelingProvide expert advice as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products within… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Office of General Counsel is seeking an Associate Director , Legal - Intellectual Property (IP) Technology & Operations to provide application ... but are not limited to:- Intellectual property (IP) Applicatio n Administration Product owner and application administrator of the cloud-based IP management system… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …4 or More Years Extensive experience in project management, process, product , and/or analytical development activities and pharmaceutical/oncology project ... defined based on the project needs and the respective development stage of the project. The CMC Lead will...transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and… more
- Merck & Co. (Rahway, NJ)
- …the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead ... and inclusive work environment.Essential Knowledge, Duties & Responsibilities for the Director Include:Sterile drug product development concepts, tools,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …safety actions, and communication and risk minimization plans.Authors or oversees the development of minimum core product safety requirements for inclusion in ... protocols (CSPs) and Informed Consent Forms (ICFs), for assigned product (s)Authors or oversees the development of the...(ICFs), for assigned product (s)Authors or oversees the development of the Safety Management Plan for assigned … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director , Program Management is a senior position responsible for ... risks as well as achieving overall project level quality metrics. An ideal Associate Director , Program Management must have the expertise and leadership to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …standards. Additionally, this role will be responsible for leading the strategic development and overseeing digital media buying for the Daiichi Sankyo US corporate ... budget and manage agency execution; including reporting and insights.Partner with Global Product PR team to increase discoverability of news release via SEM;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Strategic Planning provides strategic insights ... Pipeline compounds and launched brands. The role will be responsible for the development and maintenance of Short to Long Term Forecasts for the consolidated Global… more
- Merck & Co. (Rahway, NJ)
- …impactProactively identify key biopharmaceutics risks at each stage of drug product development for small molecules and/or biologics, conducting hypothesis-based ... highly desired.Experience in regulatory compliance expectations across all phases of product development to commercializationExperience with in silico, in vitro,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Job Summary Deliver the development and implementation of informatics systems and programs to support the ... global sites. These business functions include: Clinical Operations, Clinical Development , Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to ... under some supervision to solve complex study problems. Responsibilities Protocol Development , Case Report Form (CRF; review), Statistical Analysis Plan (SAP),… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position ... including post marketing projects and those involving 3rd party development . This position partners with GRLs and Clinical Safety...may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …industry, vendor base, and regulatory issues for respective categories. Leads the development of sourcing strategy for respective categories. Builds and maintains a ... vendor base. Manages vendor relationships. Implement sourcing and value development roadmap and initiatives; contribute to strong supplier relationship management,… more
- Merck & Co. (Rahway, NJ)
- …, and supplying Active Pharmaceutical Ingredient (API) for clinical use and drug product development . This will involve handling of a variety of reagents, ... Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual...The MACS Operations Specialist position will report to the Director , Engineering and will be a member of the… more
- Merck & Co. (Rahway, NJ)
- …and proficiencies. -To focus on realizing this objective, we are hiring an Associate Director , Technical Capability Business Engagement. -The person in this role ... in IT.Responsibilities include:Collaborate and partner closely with the Technical Capability Development Product Manager to enable and realize strategic vision… more
