- Repligen (Waltham, MA)
- …maintain strong relationships with external auditors, regulatory agencies, and industry peers. Operational Excellence : Lead root cause analyses for identified ... the SOX program. Shape and execute compliance strategy across a global company Lead SOX risk assessments, audits, and remediation efforts Partner with senior leaders… more
- Merck & Co. (Rahway, NJ)
- …and the ability to create a vision as well as execute and lead complex strategic and operational initiatives in matrix structures.Strong working knowledge ... Job DescriptionUS Lead , Medical Modernization - V&IReporting to the Head...teams, GSVC, GMVC Ops, CSEE (Center for Scientific Exchange Excellence ), Omnichannel, ACE (Analytics Center of Excellence ),… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation, ... regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and driving the methodology, approach, and… more
- Genmab (NJ)
- …Then we would love to have you join us!The Role & DepartmentThe Feasibility Lead supports the vision and strategy set forth by the Head of Strategic Feasibility. ... creation and maintenance of study-level patient enrolment forecast based on final operational plan approval and final feasibility. KPIs developed and shared across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Job Summary: The TA Oncology Strategy and Execution Lead is a pivotal leadership role responsible for driving the strategic and ... operational effectiveness of this newly formed TA Oncology organization....results, optimize ways of working and enhance overall functional excellence across the newly formed TA Oncology organization The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …related to HCP focused training materials; Has a focus on strategic and operational excellence ; Provide input in Patient Focused Initiatives in close ... collaboration with RD colleagues.Drive discussions with Clinical Operations and the scientific SMEs, prepare and Coordinate responses to queries from the clinical study sites on the Dose Preparation Instructions. Seek input from other global functions as… more
- Merck & Co. (Durham, NC)
- …Management, Management Process, Manufacturing Processes, Manufacturing Quality Control, Operational Excellence , Packaging Operations, People Leadership, People ... the unique opportunity to give input in the design process, startup their areas, and lead the teams to full production.-The ideal candidate for this role will be an… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …investment choices, drive core operations and develop insights to drive growth and operational excellence across the value chain while innovating for future ... member of the Novo Nordisk US Operations (USO) AI Center of Excellence . The individual will lead and manage a team of data scientists, including AI/ML experts… more
- Genmab (NJ)
- …and implementation of SOPs, best practices, and standards for external data workflows. Lead or contribute to initiatives that improve operational efficiency, ... regulatory compliance, and successful data submissions.The Associate Director will lead cross-functional collaboration, provide oversight of third-party data vendors,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global QMS (RD PV QA) and is a member of the leadership team. Lead an enterprise cross-functional QA team to deliver state-of-the-art data-driven solutions.Design a ... fit-for-purpose organization for operational and technical QA oversight.Drive innovative process improvements across RD, PV, and Medical Affairs by leveraging… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational planning and execution of FIH, ... Responsible for clinical program planning and execution (from study design, operational planning, start-up, conduct, reporting, and close out) including timeline,… more
- Merck & Co. (Durham, NC)
- …(LSS), Management Process, Manufacturing Processes, Manufacturing Quality Control, Operational Excellence , Organizational Compliance, Packaging Operations, ... team members in executing smaller improvement projects in their operational area - Represent Operations on project teams as...on project teams as needed - - Communication - Lead and support daily (Tier) meetings to facilitate flow… more
- Merck & Co. (Charlotte, NC)
- …Solutions leads within HR Technology as well as the Global Centers of Excellence (COE's) and Operations Teams. The Senior Specialist will support, assess and manage ... candidate will be an accomplished HR team member with project or operational team experience working globally.- Responsibilities Primary support of our Company's… more
- Merck & Co. (Rahway, NJ)
- …and mitigates risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions ... prioritizing, interrogating and mitigating risks across technical, regulatory and operational factors.- Conducts options analysis and provides recommendation to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …programs Partner with existing patient support program leads, with a focus on operational excellence in support of patient needs Develop performance dashboards ... metrics to relevant groups contributing to pharmacy operations to assess operational performance. This individual will maintain a high-level of collaboration and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pharmacy programs Support existing patient support program leads, with a focus on operational excellence in support of patient needs. Ensure vendor compliance ... metrics to relevant groups contributing to pharmacy operations to assess operational performance. Relationships Reports to the Director, Pharmacy Ops. Key internal… more
- Aequor (New Brunswick, NJ)
- …Job Description:The Senior Manager, Cell Therapy Development Operations Finance Excellence will be responsible for supporting global process continuous improvements ... surrounding CTDO activities.Work with Supply Chain and Inventory Process Excellence team to support inventory forecasting process.Proactively support internal… more
- Aequor (Thousand Oaks, CA)
- …and change control execution. This role will apply project management and operational excellence to support the execution of product launches, variation ... (SCPM) will translate product variation strategy as determined by the Variation Lead for reportable changes for Global Distribution control. May also translate… more
- Merck & Co. (Boston, MA)
- …GHH, and Manufacturing to ensure optimal decision-making and operational excellence in the leadership of Integration Teams. Lead the effective translation ... tumor strategies-are anticipatedThe Asset Team VP will manage individuals who lead multi-tumor asset teams (asset team leads). Any clinical development staff… more
- Merck & Co. (Rahway, NJ)
- …and mitigates risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions ... of Experience :- Recognized as a credible technical leader through demonstrated scientific excellence in at least one CMC function and ability to navigate through… more
