- Daiichi Sankyo, Inc. (Bernards, NJ)
- …programs.Ensure proactive representation of Quality professionals at strategic non- project team and at MA strategic discussions. Lead the Quality Reviews of ... strategic direction pertinent to MA activities for internal QA team (global/ local), but also to:Global Project ...and maintain the strategic road map, metrics, dashboard, and project management methodologies to lead an efficient… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …document and record management principles for Global GxP activitiesResponsibilitiesTraining Function Team Lead development of strategies for the needs ... training across DS group including business units, functional units and corporate functions. Lead Training function team and Document and record management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …due diligence efforts and ensure tax collaboration: work directly with the BD project lead as well as legal team to proactively inform them of the timelines ... of the Senior Director, Forecasting & Business Analytics is to lead the forecasting and financial and analytical support of commercial assets. In addition,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Team Working Group (WG) cross-functional meetings. Serve as member of the Joint Project Team (JPT) with the Diagnostic (Dx) Partner to communicate key RA ... and Switzerland. CDx RA Strategy : Align strategy with lead CDx RA representative(s) and represent Global CDx Regulatory...and risks in written and verbal format to regulatory senior leadership team and other governing bodies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in supporting RBQM activities.- Technical: Provides technical guidance in Quality by Design. Lead the team to define Critical to Quality factors, select critical ... centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring)...targeted source document verification and targeted source data review. Lead the team to develop and implement… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for GDX global and regional projects requiring Validation services and Technical Lead assignments.ResponsibilitiesOversee and manage a team of Validation Leads ... around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation,… more
- Merck & Co. (Rahway, NJ)
- …type role preferred (including experience working in managed care /health systems) Team lead or management experience preferred but not ... identifying areas of high impact and translating into messaging that resonates with senior leadership.Develop and assess team data and analytics via KPI… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Novo Nordisk US Operations (USO) AI Center of Excellence (AI CoE). The individual will lead and manage a team of data and AI engineers and developers and is ... cross-functional teams on AI development, consumption, and governance. This leader and their team work closely with...vision Build and evolve the AI Engineering & Automation team to meet internal and market needs Lead… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director, Biologics to lead all Chemistry, Manufacturing, and Controls ... biologic products, ensuring alignment with company goals and global regulatory standards. Team Development Build and lead a high-performing CMC team… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to internal audits and inspections Demonstrate leadership skills via acting as project lead on cross-functional projects in the development and/or implementation ... of uniquely complex issues in a simple and understandable manner to ie team members. Relationships Reports to head of NAO Quality PV Oversight. Maintains positive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and ... scientific direction to Clinical Operations. Represents Clinical Development on Project Teams.Responsibilities: Study Strategy: Provides the strategic direction to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur team in Rahway, New Jersey, is seeking an experienced leader who will manage a team of scientists to support drug substance process ... candidate will be a member of the BPD Leadership Team and directly responsible for a team ...recruiting, appraising, and developing personnel under her/his/their supervision. The leader will maintain a strong network internally and will… more
- Merck & Co. (Rahway, NJ)
- …and Global Regulatory Affairs.--The AVP provides leadership and direction through senior -level and first-line managers and statistical staff focused on end to ... the Oncology therapeutic area. The AVP builds and oversees a statistical team of ~20 employees focused on effective, efficient, and seamless cross-functional… more
- Merck & Co. (Rahway, NJ)
- …and ethical standards.-The Distinguished Scientist (Executive Director) and Product Development Team (PDT) lead , Oncology Global Clinical Development, has ... areas regarding clinical issues related to oncology compounds.-The Executive Director/PDT lead may:-Manage Directors and/or Senior Directors responsible for… more
- Merck & Co. (Rahway, NJ)
- …business. Primary Responsibilities and Activities include but are not limited to : Lead an Integrated Cross-Functional Team in Delivery of Reliable and Compliant ... Position Overview : Our Company is seeking a dynamic and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and influencing senior level leadership within an organization Experience as a Project Leader responsible for complex project where input and alignment ... and refine our strategies based on real-world results. We are building an intentional team culture that is made up of diverse skillsets, united by the shared belief… more
- Merck & Co. (Rahway, NJ)
- …pediatric vaccines in the Therapeutic Area. The incumbent will be expected to lead multiple programs that are in various stages of development therefore requiring ... the functions and processes relevant to vaccine development, and project management principles as applicable to the pharmaceutical industry.Primary… more
- Merck & Co. (Rahway, NJ)
- …adoption of novel process technologies - Contribute to strategic initiatives; partner with senior leaders to set overall project strategy, and guide teams ... of Biologics. You will work with an immensely creative and collaborative team of scientists and engineers to design purification processes while develop ing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …management Project Management and Quantitative analysis skills Ability to lead and influence without authority and navigate within a matrix environment Strong ... and refine our strategies based on real-world results. We are building an intentional team culture that is made up of diverse skillsets, united by the shared belief… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Bleeding Disorders TA lead (A/B). Works closely with Associate Directors and Senior Brand Managers across the Rare Bleeding Disorders TA and with individuals in ... we serve, and setting the industry standard for extraordinary execution. The team members collaborate and partner cross functionally with multiple functions and… more
