- Merck & Co. (Rahway, NJ)
- …Registrations application, including process mapping and user story creation.Collaborate with product management and development/vendor teams to contribute to ... a multiyear journey to stand-up, sustain and grow the RIM (Regulatory Information Management ) capability for our company's Regulatory.The product analyst for the… more
- Merck & Co. (Rahway, NJ)
- …introduction(s) and commercial market(s) approval(s).Define design input(s)/ output(s) and lead associated combination product design verification plan, ... studies at the device component/ subassembly/ in-process material and combination product level. Lead stablishing test methodologies/ testing readiness and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and updates Study Supply Plans in close communication with CSO project Management Lead .Responsible for the Clinical Label Development process which includes ... unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in… more
- Merck & Co. (Rahway, NJ)
- …regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership. Lead /support/oversee clinical supplies production ... respect to device component manufacture and final assembly of biologic/drug product with device constituent part. Lead /support the development, implementation and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …no Sr CMC Lead is established, take main responsibility for CMC lead . Provide operational coordination and management to drive strategies and activities for ... simultaneously. preferred- 4 or More Years Extensive experience in project management , process, product , and/or analytical development activities and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in ... organizational efficiency and decision making.Responsibilities: Project Responsibilities:Independently manage or lead strategy development for high complexity drug development projects/programs.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …position is accountable for partnering with the Global Team leader as the Project Management lead on drug development projects. This position can be assigned to ... unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in… more
- Tris Pharma (Monmouth Junction, NJ)
- …spanning neuroscience and other therapeutic categories employing our proprietary science and technology . Our science and technology make us unique, but it ... New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS) supports,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(CSPs) and Informed Consent Forms (ICFs).Collaborates with Clinical Safety Scientist Product Lead and PSL to develop the Safety Management Plan for assigned ... risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead , Product Safety Lead (PSL), Clinical Safety… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(CSPs) and Informed Consent Forms (ICFs).Collaborates with Clinical Safety Scientist Product Lead and PSL to develop the Safety Management Plan for assigned ... of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise...assigned clinical studies in partnership with Clinical Safety Scientist Product Lead , Product Safety … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for our Rare Disease/Specialty Medicine portfolio. SummaryThe Director, Clinical Safety, will be a product safety lead or part of a product safety team, ... unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …product labeling committees and other department projects/initiatives Demonstrates the people management skills needed to lead direct reports and working ... education and collecting data to support efficacy and new product development, CMR is involved. The one thing that...Are you ready to make a difference? The Position Lead the Medical Promotional Review staff and direct their… more
- Merck & Co. (Rahway, NJ)
- …expectations- Lead technical investigations of medical device and combination product needs for commercial products- Facilitate technology transfer of ... and combination products globally.- Experience in design controls, device risk management , medical device, complex combination product kits, prefilled syringes,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders.SummaryThe Director, Clinical Safety, will be a product safety lead or part of a product safety team, ... unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with line-of-business leaders to ensure their input in driving process improvement Lead change management for technology adoption. Coordinate multichannel ... etc.). Facilitate knowledge sharing and collaboration across stakeholders through regular engagement Lead source to pay technology release testing and feature… more
- Genmab (Plainsboro, NJ)
- …Sheet and US Prescribing Information depending on the role for the assigned product Consult with senior management to develop and communicate regulatory ... 60% of the time per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy, Global Regulatory Affairs, the key responsibilities include… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …alignment of relevant cross-functional medical guidance activities/platforms on specific product /project Project Management : Ensures optimal project and vendor ... Hub drives innovative strategies to advance our MASH, cardiomyopathy, and advanced technology portfolios for the benefit of patients, fostering a collaborative and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in ... medical accountability and oversight for one or more clinical trials. Matrix management responsibilities across the internal and external network. Manages Phase 1-3… more
- Genmab (Plainsboro, NJ)
- …to incorporate insights into product strategies and to support product launches and lifecycle management .Monitor ongoing investigator sponsored trials (IST) ... Hematology Strategy will report to the Director, US Medical Affairs Hematology Strategy Lead . S/he will assist the strategy lead to providing medical affairs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Company and/or departmental expectations and goals as identified by senior management .ResponsibilitiesActs as a brand attorney and lead legal advisor for ... of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise...Marketing, Global Medical Affairs). For these areas, acts as lead attorney for that area providing legal advice and… more
