- Daiichi Sankyo, Inc. (Bernards, NJ)
- …documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member with other functions, ... input on CRO and ARO Scope of Work and budget; participates in study team meetings with CRO and ARO; establishes effective communication with CRO, ARO, and vendors.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …provide GMP compliant product release documentation. Participates as a cross-functional team member to provide product quality/GMP support and assures ... the relevant documents within QA Product Release Management Organization.Cross-Functional Team Participation: Participates and supports development of cross-functional teams… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, ... and sections of submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to manage multiple tasks while working both independently and collaboratively as a team member .Proficient in at least one of the following programming languages: ... SAS, R/R Shiny, or Python. Strong communication skills. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race,… more
- Merck & Co. (Rahway, NJ)
- …Regulatory Affairs, Procurement, and suppliers.Key Functions Work Independently and as a Team member with Integrity - Precision - Accomplishment - Motivational ... The Senior Engineer in Device Technology is a key member of our Device Development & Technology Team... member of our Device Development & Technology Team , with responsibilities supporting the commercialization and sustainmentof medical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …project budget and resource plan in partnership with the Project Sponsors, Finance team member , and functional line representatives on the teamResponsible for ... is seeking Senior Project Manager, PMO as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be responsible for providing… more
- Formation Bio (New York, NY)
- …and key decision-makers. Ability to work independently while remaining an active team member in a fast-paced, innovative environment. Strong business acumen ... behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same...at the company shares these same values, and every team and individual plays a key part in our… more
- Tris Pharma (Monmouth Junction, NJ)
- …successful business and take pride in the company's success. But of equal importance to each team member is how we interact with one another on a daily basis. We ... and technology make us unique, but it is our team members that set us apart; they are the...open and honest communications to help support individual and team success.We have an immediate opening in our Monmouth… more
- Tris Pharma (Monmouth Junction, NJ)
- …successful business and take pride in our company's success. But of equal importance to each team member is how we interact with one another daily. We believe in ... technology.Our science and technology make us unique, but our team members set us apart; they are the engine...open and honest communications to help support individual and team success.We have a position available in Monmouth Junction,… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …Sr. Scientist, In-Vivo Pharmacology as part of the Research and Early Development team based in Philadelphia, PA. Role OverviewLegend Biotech USA, Inc. is seeking an ... experienced senior in vivo pharmacologist to join our in vivo pharmacology team responsible for conducting in vivo studies with mice and NHP to support pipeline… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaboration with Global Regulatory Leads (GRLs). This position may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late ... position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …functions and sites. The individual assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, ... product safety lead or part of a product safety team , and be responsible for overall product safety strategy...safety monitoring and risk management through the Safety Management Team framework. This individual will use strong leadership and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaboration and ensure effective PM resourcing to projects within the portfolio. As a member of the GMP&L leadership team this position is also responsible for ... an integrated drug development strategy and tactical plan including options analysis of team 's proposals in partnership with a Global Team leader for high… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …product development plan. This position is accountable for partnering with the Global Team leader as the Project Management lead on drug development projects. This ... work on projects at any stage of development.As a member of the GMP&L function this position is also...phase of development. Develops and maintains a high performing team . Manages the GPT in partnership with the Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. Job Summary: The Manager, Clinical Data Repository Administration is a member of the Biostatistics and Data Management Data Operations team and ... users to roles based on authorized requests from study team members, periodic review of user access and audit...on the requests submitted by DM and authorized study team members. Proactively identify and resolve issues that may… more
- Tris Pharma (Monmouth Junction, NJ)
- …a successful business and take pride in the company's success. But of equal importance to each member of the team is how we interact with one another on a daily ... and technology make us unique, but it is our team members that set us apart; they are the...open and honest communications to help support individual and team success. Our Packaging Department located in our Monmouth… more
- Tris Pharma (Monmouth Junction, NJ)
- …a successful business and take pride in the company's success. But of equal importance to each member of the team is how we interact with one another on a daily ... and technology make us unique, but it is our team members that set us apart; they are the...open and honest communications to help support individual and team success. Located in Monmouth Junction, New Jersey, Tris… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …across various departments of Daiichi Sankyo. You will join a global team of talented AI engineers collaborating with cross-functional teams to deliver innovative ... scalability, and reliability.- Drive the organization's GenAI strategy forward as a member of the GenAI Center of Excellence (CoE). This includes establishing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …will drive creation of demand and revenue forecasts. The Associate Director is a dynamic member of the Global Oncology I&A Team and partners closely with Market ... Alliance Partner(s). This individual will work closely with Global Market Research team members to integrate insights and key assumptions into forecast models and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as management of adverse events based upon approved Safety Management Team (SMT) materialsSupports overall program safety reporting (eg, Periodic Safety Update ... assessments for license renewals, responses to Health Authority)Participant and voting member in the labeling development process in the Labeling Working … more
