- Merck & Co. (Rahway, NJ)
- …messaging and outreach strategies.Guide vision and structure of enterprise social intelligence operations , serving as lead contact for all social intelligence ... of our communications efforts.Scope of work and core responsibilities include: Lead the development of communication strategies grounded in data insights,… 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & Clinical ... across regions and functional areas. The role of the Global Process Lead involves developing and maintaining efficient, effective, and compliant business standards,… more
- Merck & Co. (Rahway, NJ)
- …Description: The Office of General Counsel is seeking an Associate Director, Trademark Operations to provide docketing and legal operations support to the ... Property (IP) organization. Primary responsibilities are to oversee the Trademark Operations team, including operations and workflow; partner with the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Warehouse Operations Manager as part of the Technical Operations team based in ... Warehouse Operations Manager will work within Technical Operations and be responsible for the ongoing site ramp-up,...solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Operations Manager as part of the Technical Operations team based in ... Raritan, NJ. Role OverviewThe CAR-T Operations Manager is an exempt level position working within...execution of daily production schedules. This individual will also lead facility operating review meetings and own various department… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …visits (expectations of staff contact, ISF review, IP review, SDV/SDR, etc.)Establish and lead the Sponsor Oversight Visit process. Provide oversight of the DS Trip ... and escalate significant issues and findings in a timely manner. Study Operations Oversight Management:Contribute to the oversight of Qualification and Training of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to comments from ... may manage assigned staff, partnering with the Global Labeling Operations & Compliance group and across the cross-functional and...Data Sheets, EU and US Documentation: As the project lead , Independently or through direction of a team of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to comments from ... may manage assigned staff, partnering with the Global Labeling Operations & Compliance group and across the cross-functional and...Data Sheets, EU and US Documentation: As the project lead , Independently or through direction of a team of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stakeholders on important drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of Clinical Safety and risk ... functions, eg Clinical Development, Medical Affairs, Regulatory Affairs, Clinical Operations . Formulates strategic approaches for risk mitigation for global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU. ... labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.Ensure… more
- Merck & Co. (Rahway, NJ)
- …realize strategic vision and direction and deliver business processes.Serve as lead change agent for Technical Capability Development, socializing the vision, ... change and communications teams, TCD leadership, and others as necessary.Activate and lead and DigitalYou Learning Council to create synergies across IT to deliver… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …attorney and lead legal advisor for the commercial business and operations supporting US approved (or to be approved) oncology products.Acts as legal advisor ... the primary legal advisor for the commercial business and operations supporting US approved (or to be approved) oncology...Marketing, Global Medical Affairs). For these areas, acts as lead attorney for that area providing legal advice and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …initiatives/projects and improving the efficiency and/or effectiveness of internal operations of MCT.Responsibilities- Provide MCT system support and access ... scheduling meetings and managing agenda development, meeting minutes, and action log.- Lead the management of shared repositories for function.- Assist in the… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description: The GMP Operations branch of Biologics Analytical Research & Development (BAR&D) seeks a driven leader to advance and commercialize ... Director of Compliance, reporting to the Senior Director of GMP Operations , will oversee laboratory compliance across multiple sites, managing regulatory audits,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: ... regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before database lock and quality check… more
- Merck & Co. (Rahway, NJ)
- …substance (upstream, downstream, and conjugation) and drug product manufacturing unit operations using a variety of process-modeling tools.-As a potential candidate, ... help with development, commercialization, and troubleshooting of large-molecule unit operations .Using modeling solutions, support process development, process characterization, scale-up,… more
- Merck & Co. (Rahway, NJ)
- …Infrastructure. This position will be a member of the Research Automation Operations product (Laboratory and Plant) within RIPL. -As Sr. OT Infrastructure ... Specialist, you will lead the definition and implementation of high-level requirements, principles...impact to automation systems with IT driven firewall rule changes. Lead /assist project scopes, define IT and infrastructure deliverables, timelines… 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 ... technical detailBuilds collaborations across internal departments and key stakeholdersAbility to lead and champion organizational structure and be a change agent… more
