- Merck & Co. (North Wales, PA)
- …(eg, Diagnostic Development Teams) and to external diagnostic business partners.-Coordinating and leading regulatory interactions with diagnostic partners ... and diagnostic partners to determine best practices and least burdensome regulatory paths to facilitate development and global registration activities.Assessing… more
- Merck & Co. (Rahway, NJ)
- …cross-functional Device Working Group to ensure full integration of the device development activities with the clinical, regulatory , formulation, commercial and ... the program-specific design controls process and design history file development .Author and review relevant portions of the regulatory...then your employment may pose an undue burden to business operations, in which case you may not be… more
- Merck & Co. (Rahway, NJ)
- …and solutions to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory ... final approval of all submissions and associated documentation.Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and China, and indirect accountability for JP representatives. As part of leading Regulatory Intelligence, this role will lead the development and implementation ... these findings to relevant cross-functional stakeholders, to help inform future DS regulatory / development strategies, activities and ways of working. This role… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description Associate Director , Automation The Associate Director Manufacturing Automation is responsible for managing the team in ... to;Directing the technical activities of a professional staff to achieve facility business objectives with on the production shop floor support as neededProviding… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …innovative and flexible approaches to achieve development goals, advise on development strategies, and deliver on associated regulatory activities Lead the ... advanced degree is strongly preferred Minimum of 10 years drug development /FDA/ regulatory related industry experience required Demonstrated knowledge of global… more
- Merck & Co. (Rahway, NJ)
- …out R&D activities partnering across the network to enable process and formulation development .- In this position, the SMAR&D Director will set guidance, lead ... understanding of the regulatory environment, and a-vision to influence the regulatory environment.Nature and Scope of Position:The Director reports to the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …action, guide the Business units and the Clinical, Medical, and Regulatory Affairs (CMR) teams on strategy development and execution. This person ... with other Enterprise Insights, Data & Analytics functions and translating into business impact. Relationships Reports to the Senior Director , Enterprise… more
- Merck & Co. (North Wales, PA)
- …The Director will manage the entire cycle of clinical development , including: study design, placement, monitoring, analysis, regulatory reporting, and ... regulatory affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Senior Director , Executive Director… more
- Tris Pharma (Monmouth Junction, NJ)
- …in our Monmouth Junction, NJ facility for an experienced MD to serve as Senior Director or Director , Clinical Development . Title and salary commensurate with ... oversight of clinical study conduct; Collaborates closely with internal stakeholders, (ie Regulatory Affairs, Product Development , Research and Development … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the written deliverables that support the clinical development and regulatory requirements of a clinical program. The Director will provide high ... input into development plans, study designs, and regulatory submissions. The Director will provide direction...measurements that are consistent with the priorities of the business , and that interim reviews are held so that… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including Translational Medicine and biomarker strategy; Thought partner in driving Business Development decisions in collaboration with External Scientific ... relationship with top KOLs; Thought partner with Ext Scientific Affairs on Business Development activities for late stage compounds; Committee member,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …considers relevant input and guidance to other areas within NACD including Operations Director and TA Heads Analyze And Anticipate Business Needs: Utilizes ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , Commercial Learning & Development , will be a key member ... the Commercial Effectiveness organization, primarily responsible for the successful development , delivery and management of comprehensive training (ie: product,… more
- Insmed Incorporated (San Diego, CA)
- …to the Executive Director of Program Management, the Associate Director , Program Management supports the cross-functional drug development and ... planning, executing, controlling, reporting, and terminating the integrated Program and Functional development plans. As a leader, the Associate Director of PM… more
- Merck & Co. (Rahway, NJ)
- …in key areas across the team - related to engagement in clinical, business development and omnichannel and data and analytics topics.Education Minimum ... Marketing for Women's Cancer for the oncology portfolio.- The Global Marketing Director will lead overall strategy development for Women's cancer portfolio,… more
- Eisai, Inc (Nutley, NJ)
- …of resources.Demonstrate product differentiation and value to support medical development , additional (post approval) regulatory and safety needs.Ensure ... patient charts, administrative claims datasets.Previous RWE experience in clinical/medical development , and interactions with regulatory authorities is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …material for KOL interactions on a program-based need; Peripheral involvement in Business Development activities for late stage compounds Involvement with ... Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation… more
- Merck & Co. (Rahway, NJ)
- …DescriptionThe Director of Biologics Potency in Analytical Research & Development is responsible for providing strategic and technical leadership for a portion ... to bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and… more
- Tris Pharma (Monmouth Junction, NJ)
- …and actively engages with Food and Drug Administration (FDA) and other regulatory agencies and health authorities throughout development lifecycle of projects ... Tris colleagues understand the criticality of operating a successful business and take pride in the company’s success. But...the pharmaceutical industry, including but not limited to: drug development and regulatory processes and ability to… more
