- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …based on the project needs and the respective development stage of the project. The CMC Lead will support the Sr . CMC Lead on complex and/or late-stage ... and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status... teams within overall CMC development project(s), to support Sr CMC Lead . In case no … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key ... clinical trial performance and quality metrics and share with study team, Operations Program Lead , and Sr . Director for the compound, on regular basis and ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing Clinical ... development of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies, conduct hands on… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. SUMMARYThe Associate Director, Pharmacoepidemiology position provides epidemiologic, methodological, and analytic ... analysis of epidemiologic studies, including real-word evidence (RWE), supporting senior management in various epidemiological activities.This position independently carries… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... 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)
- Job DescriptionThe Senior Clinical Director ( Sr . Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. Specifically, The Senior Clinical… more
- Insmed Incorporated (Bridgewater, NJ)
- …the reinforcement and ongoing growth of our culture. This position will report to the Senior Director, HCP and Payer Lead . This position does not have any direct ... in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director, HCP Marketing will be a key member...develop plans and utilize appropriate tools and tactics to lead HCP personal and non-personal brand initiatives. As with… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Vice President (AVP) will be responsible for leading the Translational Medicine (TMed) Cardiovascular & Respiratory Therapeutic Area and ... own Cardiovascular & Respiratory strategy with other TA Heads (Discovery/Late-Stage) Lead key technical reviews for Cardiovascular & Respiratory assets Conduct DRC… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Co- Lead Deviation Investigations: Collaborate closely with the Quality Associate Director to co- lead the deviation investigations management system. ... in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical… more
- AbbVie (Madison, NJ)
- …with multiple driver indications within a Therapeutic Area and support the Manager, Global Regulatory Lead (GRL), Associate Director, or Director, in the ... on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Senior Manager, Global Regulatory Strategy, US & Canada, AbbVie Inc., Madison / Florham… more
- Lilly (Branchburg, NJ)
- …and departments. Participate in audits performed by partners, Lilly corporate, and/or regulatory agencies, as applicable. Identify and lead process improvement ... (materials management, warehouse etc.) by conducting periodic walkthroughs. Ensures regulatory compliance and procedural consistency between manufacturing facilities. Prepares… more
- Citigroup (New York, NY)
- …Technology & Communications Investment Banking (IB) Business Execution Group is a senior level position that will be responsible for supporting the overall ... necessary. In addition, tasks may include supporting the Business Execution Lead on managing compliance, external audits, business continuity activities and/or… more
- Pfizer (Parsippany, NJ)
- …but will often act under the support and direction of the Senior Manager, Cybersecurity Network Protection Lead : + Analyze business requirements ... and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's...disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of… more
- Sanofi Group (Bridgewater, NJ)
- …responsibilities:** As an Associate Statistical Project Leader in Biostatistics, you will lead one or several late phase studies, or lead an indication for ... the statistical integrity of the content according to internal standards and regulatory guidelines + Propose, prepare and perform exploratory data analyses, ad-hoc… more
- ThermoFisher Scientific (Newark, NJ)
- …process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from ... to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close… more
- Kohler Co. (New York, NY)
- ** Sr . Software Engineer Security - Kohler Ventures** _Work Mode: Hybrid_ **Location:** Hybrid, 2-3 days/week onsite at Palo Alto, CA or NYC **Opportunity** Kohler ... Our mission is to build new digital businesses that empower consumers to lead healthier lives. We explore how familiar experiences can be enhanced and innovations… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The ** Sr Manager, Clinical Drug Supply & Logistics** is responsible for providing oversight of individual or multiple clinical programs, forecasting Investigational ... within budget and with good quality, in compliance with Regulatory Authorities' regulations / guidelines and Regeneron SOPs /...typical day might include the following:** + Serves as lead drug supply manager of a program and/or individual… more
- ConEdison (New York, NY)
- System Operations Risk Threat Management ( Sr System Analyst) Job Info 112269 Posting Expiration Date:May 26, 2024 Schedule Type:Full-Time Minimum Salary:$95000 ... & Heavy-Duty Infrastructure Program Operations Category Manager, Supply Chain (https://careers.coned.com/jobs/14398772-category- lead ) Operating Supervisor, OR Electric Ops - Central OH… more
- Medtronic (New York, NY)
- …analyze literature search results + Address deficiencies and or answer questions from regulatory agencies as needed + Create and manage project schedule for each ... Develop and maintain in-depth knowledge of clinical evaluation best practices and regulatory agencies' guidelines on clinical evaluation requirements + May lead … more
- PSEG (Edison, NJ)
- …well as the attention, camaraderie and care for one another you might typically associate with a small business. Our focus on combatting climate change through clean ... PaaS and IaaS solutions. + Experience in a team lead role through projects and other work planning experiences....in SAP, Salesforce integrated with MuleSoft. + Utility and/or Regulatory Business Knowledge. **Minimum Years of Experience** 6 years… more
