- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech 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 operational excellence project management support to the cGMP Clinical and Commercial Cell...office to enable robust production, testing and release of product to patients.Key Responsibilities Helps to develop and support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for preparing scope change proposals and stage gate proposals for formal presentation to senior management . Can step in, as needed, on behalf of the Global ... organizational efficiency and decision making.Responsibilities: Project ResponsibilitiesIndependently manage or lead strategy development for high complexity drug development projects/programs.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … product distribution solutions Navigate and serve as point compliance audits and lead management of solutions to compliance issues as they arise Functions ... with us? The Position Responsible for overseeing and managing all NNI patient product access programs to ensure Novo Nordisk's commitment to patient-centered care as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... no Sr CMC Lead is established, take main responsibility for CMC lead . Provide operational coordination and management to drive strategies and activities for… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionSr. Principal Scientist - Device Technical and Engineering Lead (Sr. Director Equivalent)Our company's Device Product & Process Development Team ... regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership. Lead /support/oversee clinical supplies production… 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 ... scope change proposals and stage gate proposals for formal presentation to senior management .Is comfortable working independently within a matrix environment and… more
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to ... lives for a living. Are you ready to make a difference? The Position Senior , Clinical Informatics leads the functions in the Clinical Data Science & Evidence (CDSE)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …technology solution providers. Relationships This position will report to the Senior Director, Procurement Operations, Digitalization and BI Lead , and ... line-of-business leaders to ensure their input in driving process improvement Lead change management for technology adoption. Coordinate multichannel… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Master's degree preferred A minimum of twelve (12) years of relevant marketing, new product and sales, product management experience, demonstrating a steady ... as we embark on shaping our future. The Position The Hemophilia TA Lead is instrumental in shaping and executing NNI's strategic direction and initiatives within… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and summarize conclusions and recommendations for discussion with and presentation to senior management . Schedule and lead diligence meetings with ... disorders. Summary The purpose of this job is to lead certain pipeline support activities and assist in the...RD Finance, RD (GPTL), BD Legal and others) and Senior Management Global BD/DS Corporate Tokyo to… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …investigators, key opinion leaders, consultants, and key customer groups. Essential Functions Lead US input to overall product development Collaborate iwth NNI ... education and collecting data to support efficacy and new product development, CMR is involved. The one thing that...a difference? The Position The Strategy Director is a senior individual contributor role, and the job function requires… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Company and/or departmental expectations and goals as identified by senior management .ResponsibilitiesActs as a brand attorney and lead legal advisor for the ... Marketing, Global Medical Affairs). For these areas, acts as lead attorney for that area providing legal advice and...current developments in several key legal areas and provides Senior Management and other business leaders with… more
- Formation Bio (New York, NY)
- …role supports CMC development activities, including specification development, manufacturing, product release, stability programs, change management , and vendor ... and more efficiently.About the PositionThe Sr. Director, GMP Quality Assurance will lead the GMP QA strategy and execution for Formation Bio's portfolio. Acting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and align processes that address global CSPV objectives by working with CSPV senior management and leadership. Provide coaching, motivate, direct, and foster ... disorders. Job SummaryThe position develops the global safety strategy, oversees risk management activities, and recruits and develops staffing for at least one… more
- Tris Pharma (Monmouth Junction, NJ)
- …New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS) supports, ... oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team to ensure manufacturing quality controls and procedures are… 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)
- …effectively communicate with stakeholders at various levels, including cross-functional teams, senior management , external vendors, and clinical sites. Strong ... and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings.-...used within the assigned program(s) ( ie Bulk Drug Product ).- - Oversees all bulk drug supply management… more
- Merck & Co. (Rahway, NJ)
- …and combination products globally.- Experience in design controls, device risk management , medical device, complex combination product kits, prefilled syringes, ... how activities link to our Company strategy and business goals- Utilize device risk management tools to build device or combination product risk management … more
