- 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)
- …Global Regulatory Lead for asset to reach resolution.Participate in global product team meetings to provide US regulatory support and guidance as needed and ... matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Specialist, Global Pharmacovigilance will be responsible for some or all of the following core activities:Case review/approval for assigned ... external stakeholders (eg, Competent Authorities) for products for which the Senior Specialist is responsiblePV Statement preparation in compliance with relevant… more
- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionAs a Senior Software Engineer you will be a major contributor to the tech future ... integrations, and everything in between. You will be an integral voice in product development and execution, leading the creation of innovative and solid software to… more
- Merck & Co. (Rahway, NJ)
- …Research Infrastructure Product Line (RIPL) engineering team is seeking a Senior Specialist - Research Automation OT Infrastructure. This position will be a ... member of the Research Automation Operations product (Laboratory and Plant) within RIPL. -As Sr. OT...within RIPL. -As Sr. OT Infrastructure Specialist, you will lead the definition and implementation of high-level requirements, principles… 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)
- …efficiency and decision making.Responsibilities: Project ResponsibilitiesIndependently manage or lead strategy development for high complexity drug development ... the Global Team Leader to drive strategy development and create an integrated product development plan and timelines. Ensure execution of overall plan and annual… more
- Formation Bio (New York, NY)
- …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 ... role supports CMC development activities, including specification development, manufacturing, product release, stability programs, change management, and vendor oversight.… more
- Merck & Co. (Rahway, NJ)
- …rigorous scientific and ethical standards.-The Distinguished Scientist (Executive Director) and Product Development Team (PDT) lead , Oncology Global Clinical ... areas regarding clinical issues related to oncology compounds.-The Executive Director/PDT lead may:-Manage Directors and/or Senior Directors responsible for… 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 ... research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within projects, and… more
- Merck & Co. (Rahway, NJ)
- …customers both internal and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the ... ogram (s) . The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie clinical… more
- Merck & Co. (Rahway, NJ)
- … Lead technical investigations of medical device and combination product needs for commercial products- Facilitate technology transfer of medical device ... Job Description Summary, Focus and Purpose The Senior Engineer in Device Technology is a key member of our Device Development & Technology Team, with… 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 potential ... disorders. Summary The purpose of this job is to lead certain pipeline support activities and assist in the...support more complex projects, including those to acquire new product opportunities or technologies to augment our pipeline. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …achievement of Company and/or departmental expectations and goals as identified by senior management.ResponsibilitiesActs as a brand attorney and lead legal ... 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 updates regarding… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Project Teams including strategic development and execution of an integrated product development plan. This position is accountable for partnering with the ... Global Team leader as the Project Management lead on drug development projects. This position can be...strategy development and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader to… more
- Lundbeck (New York, NY)
- …and promotion of Lundbeck products in a distinct geographical region. The product portfolio currently includes both medical benefit and specialty distribution for ... team. Responsible for additional home office responsibilities assigned by senior management. REQUIRED EDUCATION, EXPERIENCE and SKILLS: Accredited Bachelor of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …risk management activities for his/her portfolio. Serves as the company's senior representative with key high-level internal and external stakeholders on important ... drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of Clinical Safety and risk management activities. Providing… more
- Merck & Co. (Rahway, NJ)
- …value and enabling fact-based decision making throughout the lifecycle of the product . This role will be responsible to support brands with go-to-market strategies ... and internal clients such as marketing brand leaders, center of excellence teams, senior management etc., to stay abreast of business trends, understand the business… more
- Merck & Co. (Rahway, NJ)
- …position available at our company's research facility. The Principal Scientist is a senior scientific role tasked with working closely with the group Director to ... define group strategy and to lead a team of scientists in solving complex analytical...testing of clinical trial material and in support of product and process development.A strong team player with excellent… more
- Wells Fargo (New York, NY)
- **About this role:** Wells Fargo Credit Card Loyalty and Rewards is seeking a Senior Lead Product Manager to drive the modernization of our Loyalty and ... business divisions at wellsfargojobs.com. **In this role, you will:** + Lead Product Discovery to optimize the Reward capabilities for Platform Modernization +… more
