- Merck & Co. (Rahway, NJ)
- …device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position ... applicable regulatory, quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within projects, and ... the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead ...budget, timeline, achievement of defined milestones and overall project risk management. He/she will assess project issues and develop… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary The Oncology Early Development Center (OEDC) Program Lead , who directly reports to the Head of the OEDC, supports the OEDC ... innovative, science-driven portfolios with an equally robust and agile infrastructure. The Program Lead plays a central role in supporting OEDC to drive strategy and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and ... of systems development for global informatics systems, ETL and integrations. The Tech Lead must develop and implement informatics systems and programs to support the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for synergies between the products. When goals are tactically misaligned or at risk for these assets, this leader will be responsible for bringing the issue ... 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. (North Wales, PA)
- …progress and identify risks and cross-functional interdependencies across all launch workstreams. Lead scenario planning, risk assessments, and prioritization of ... decision-making.Work closely with cross-functional teams and Global Centers of Excellence (COEs). Lead the team to effectively meet launch timelines.Explore and drive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …project team level and relevant governance bodies.Triage, resolve or escalate study issues / risk mitigations to the Operations Program Lead and study team ... primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan including critical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Director of Device Product Stewardship will lead a department of up to 15-20 personnel overseeing technical support and product stewardship ... rigorous technical support processes to support manufacturing sites, proactive risk management, performance monitoring, continuous improvement activities that ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. Job SummaryThe position develops the global safety strategy, oversees risk management activities, and recruits and develops staffing for at least ... 3/4 program.This position identifies and selects resources/tools to facilitate risk management during development and post-market. Additionally, this position… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …of good engineering practice (GEP) industry standards, science and risk -based verification requirements and is required to supply support/technical knowledge ... and implementation of the GEP program and validation standards based on risk -based practices as prescribed in ASTM E2500. Also, will work with NNUSBPI… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …plans across functional teamsDefines the interdependent deliverables and ensures that quality, risk , cost, time are managed within the overall approved plan to drive ... criteria for the project.Develops options and solutions to complex project risk problems, providing guidance to leadership including trade-off and implications… more
- Genmab (Plainsboro, NJ)
- …directly to the VP and Global Head of Information Security and IT Risk & Compliance, playing a strategic role in the Information Security Leadership Team.Primary ... to the VP, Global Head of Information Security and Risk & ComplianceSecurity Officers in other Genmab locations (US,...Medical Affairs, VP Regulatory Affairs, GM Genmab US, IT Lead in Japan)Peers within IT&D, such as Leadership Team… more
- Merck & Co. (Rahway, NJ)
- …Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team that will build biopharmaceutics ... policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate will also… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the ... of product licenses (eg, Core Data Sheet generation/revision; clinical benefit- risk assessments for license renewals, responses to Health Authority)Participant and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is in a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs), who are responsible for the delivery ... cross-functional meetings or other relevant activities.Support the External Partner Quality Lead (s) (EPQLs), who are responsible for delivering and executing Quality… more
- Merck & Co. (North Wales, PA)
- …for Product Manager - PV Case Intake and Processing. Reporting into Product Line Lead Patient Safety and Quality & Compliance, this position will be responsible for ... all PV processes, including adverse event reporting, signal detection, and risk management activities.-Manage PV systems: Responsible for managing PV systems,… more
- Merck & Co. (Rahway, NJ)
- …leverages significant depth and breadth of scientific/technical experience to: (i) lead and contribute to assigned late-stage Active Pharmaceutical Ingredient (API) ... characterization projects, (ii) mentor junior staff within the CCT organization, and (iii) lead or support internal and external development with line of sight to… more
- Aequor (Houston, TX)
- …supplier scorecards and performance metrics. Support the development of supply risk management strategies and drive development and implementation of appropriate ... risk mitigation plans. Manage relationships with suppliers acting as...category strategies are translated into project execution plans. Plan, lead and execute negotiations of assigned packages on specific… more
- Merck & Co. (Rahway, NJ)
- …globally. We are currently recruiting for an Associate Vice President (AVP) to lead global marketing for our Global Ophthalmology Franchise.For more than 35 years, ... and treatment of vision loss associated with retinal vascular leakage, a known risk factor for retinal diseases.This is an exciting opportunity to help patients and… more
- Aequor (Thousand Oaks, CA)
- …support and training opportunities to Talent Acquisition, HR colleagues and staff. Lead escalations between immigration counsel, staff, HR and management Oversee US ... 's immigration counsel, help identify long term sponsorship issues and communicate risk to Talent Acquisition and Hiring Manager. Coordinate process of posting LCA… more
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