- Eisai, Inc (Nutley, NJ)
- …Assurance (CQA) strategy including audit and inspection management, issue management and oversight of the Quality management system. This role is responsible for ... Good Clinical Practice (GCP) and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all… more
- Merck & Co. (Rahway, NJ)
- …or external stakeholders (eg, Competent Authorities) for products for which the Senior Specialist is responsiblePV Statement preparation in compliance with ... oversight of team projects/activities, including tracking progress and compliance with projected timelinesFacilitate group meetingsManage team questions and… more
- Tris Pharma (Monmouth Junction, NJ)
- …and contract negotiation, as needed; Monitors supplier performance and conduct regular business reviews; Provides guidance and oversight for new sourcing, ... capital equipment requirements Identifies and mitigates risks in procurement, ensuring business effectiveness, continuity and compliance ; Develops and enforces… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Senior Director of Clinical Operations will manage clinical operations staff to ... ensure ongoing collaboration and communication with internal stakeholders. Detailing The Senior Director will ensure a robust communication plan including status and… more
- Merck & Co. (San Diego, CA)
- …contact, with significant experience, the Liaison provides strategic regulatory oversight to accelerate approvals and optimize product labeling.This position ... with global regulatory authorities to ensure successful registration and compliance . Global Immunology submission experience in IBD strongly preferred. Primary… more
- Merck & Co. (Rahway, NJ)
- …pipeline, plus growth of existing products. This position will involve oversight of late-stage method development, validation, and life-cycle management of methods ... by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …QA is responsible for providing strategic leadership and comprehensive quality oversight across all Medical Affairs programs. This role involves deputizing for ... the Sr. Director, representing the Quality organization at senior levels. The Director plays a pivotal role in...high impact projects, fostering s culture of excellence and compliance and working toward building a quality mindset with… more
- Merck & Co. (Rahway, NJ)
- …real-time, proactive advice and guidance.Escalates potentially significant inspection findings/ compliance risks/impact to Company Senior Management.Develops the ... proactively embed quality into our Company's sponsored trials, ensure adequate vendor oversight and address any quality issues as needed.The incumbent will be… more
- Merck & Co. (Rahway, NJ)
- …our Device Development & Technology (DD&T) organization to serve as a senior technical subject matter-expert and advisor for our Autoinjector platform. This role's ... from early development through lifecycle management, providing critical technical strategic oversight and guidance across all teams involved in the development and… more
- Merck & Co. (Rahway, NJ)
- …Medical strategy and execution.Primary Responsibilities:Leadership and ManagementServes as a senior leader in the USMA organization, sets the strategic direction ... strategic alignment, optimal resource allocation, and effective representation with senior leadership.Assumes leadership of strategic insight collection and ensures… more
- Merck & Co. (North Wales, PA)
- …teams to deliver projects and products that improve human health and business .- -Under GPAM, the CMC Integrated Project Management (CIPM) organization supports ... Manager & Portfolio Lead, the core responsibility of this senior Project Manager (PM) role will be to manage...will be to manage CMC programs, due diligence and business development activities independently, regardless of complexity, phase or… more
- Merck & Co. (PA)
- Job DescriptionThe Senior EHS Specialist is a member of the Product Stewardship team under GSE (Global Safety and the Environment). The successful candidate will ... lead and manage projects.The responsibilities include:Ability to provide technical oversight to Safety Data Sheet (SDS) Authors.-Responsibilities of assigning… more
- Merck & Co. (Rahway, NJ)
- …Development, Cell Based Sciences in Rahway, NJ is seeking a motivated senior level scientist with extensive experience in biologics potency assays. More ... problem solving for complex projects across the large molecule portfolio. Oversight of developing MoA-reflective potency methods using innovative and state-of-the-art… more
- Merck & Co. (Rahway, NJ)
- …and Scientific Affairs as well as Outcomes Research.Under the guidance of a senior leader, this individual will lead a team of outcomes research professionals to ... critical part of this role. The Executive Director has scientific and budgetary oversight for all outcomes research activities conducted by their team. These include… more
- Eisai, Inc (Nutley, NJ)
- …hoc internal communications activities including department newsletter, and other senior -level medical communication initiatives as needed.Manage and support the ... provide input into CME budget and website portal as needed. Ensure compliance with regulatory and other ethical guidelines relevant to the pharmaceutical industry,… more
- Insmed Incorporated (San Diego, CA)
- …risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs in alignment with Insmed's ... business needs.ResponsibilitiesResponsibilities:Independently serving as the regulatory representative on cross functional teamsCommunicating regulatory strategies… more
- TD Bank (Greenville, SC)
- …regarding responsiveness and appropriateness.** **Summary about role:** **In this position, the Senior Compliance Business Oversight Analyst** **will ... identify potential concerns, escalate as necessary and recommend a resolution. The Senior Compliance Business Oversight Analyst** **will review marketing… more
- TD Bank (Mount Laurel, NJ)
- …the role which is outlined in the general summary below. **Job Summary:** The Senior Compliance Business Oversight Analyst provides objective guidance, ... you more specific details for this role. **Line of Business :** Compliance **Job Description:** **Why Work with...Wealth Compliance acts as an independent regulatory compliance and conduct risk management and oversight … more
- TD Bank (Mount Laurel, NJ)
- …with a team of enthusiastic colleagues dedicated to setting new industry standards. The Senior Compliance Business Oversight Manager - Collections will ... may vary depending on availability and individual circumstances._ **Job Description Summary** The Senior Compliance Business Oversight Manager provides… more
- TD Bank (New York, NY)
- …depending on availability and individual circumstances._ Job Summary: The ** Senior Manager, Compliance Business Oversight ** manages and leads a team of ... Compliance laws + Works with executive team, senior business unit management/partners to develop proactive...subject matter expertise and Compliance advice to business management + Maintains oversight (via review… more
