- Genmab (Plainsboro, NJ)
- …development of global (and US) regulatory strategies (depending on the assigned project/projects) to advance Genmab's portfolio of development pipeline candidate ... FDA) as the primary contact for the company for assigned programs. This position is based in our Princeton,...to: Act as the US/Global Regulatory Leader (GRL) for assigned project(s) and be responsible for the development, implementation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to realize your potential? The Position Strategically manages assigned litigation and investigation matters (commercial, contract, employment, antitrust, False ... organizations and other external agencies. Essential Functions Strategically manages assigned litigation and investigation matters (contract, commercial, employment, antitrust,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …will provide strategic regulatory advice on advertising and promotion for assigned products in accordance with business goals and objectives, FDA regulations ... process Serve as a primary regulatory advertising and promotion reviewer for assigned products Liaison with OPDP regarding advertising and promotion for assigned… more
- Novo Nordisk Inc. (Philadelphia, PA)
- …ready? The Position This position represents Novo Nordisk (NN) within an assigned territory. This position has a goal of cultivating strong professional ... of patients with obesity to maximize sales within an assigned territory. The OCS must achieve sales goals by...standing by not exceeding the Novo Nordisk points threshold assigned based on review of Motor Vehicle Records. Qualifications… more
- Genmab (Plainsboro, NJ)
- …not limited to: Act as US regulatory lead and FDA contact person for assigned project(s) and be responsible for the implementation and maintenance of the US ... Clinical Trial Teams, and other cross-functional teams as required for the assigned project(s). Participate in the development of and assess the appropriateness of… more
- Taiho Oncology (Philadelphia, PA)
- …to ensure successful implementation of the medical affairs strategic plan within an assigned geographic region. The MSL brings relevant insights from the field on ... and implement plans to support Medical Affairs strategic direction for assigned territory, eg medical territory plan Training/Education Resource: Develop, maintain… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …role serves as the lead Ethics & Compliance Business Partner for assigned departments and/or functional areas, working collaboratively to identify and mitigate ... direction and oversees activities related to ethics and compliance for assigned departments and/or functional areas to ensure compliance principles are considered… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …decision-making to support the achievement of Novo Nordisk P&L goals for assigned products. Collaborate with marketing, medical, finance, global colleagues, and key ... to manage multiple projects, to achieve specific research goals as assigned . External relationships include interactions with outside consultants and research… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Novo Nordisk A/S (NN) to drive successful project outcomes for assigned projects. Develops and maintains positive working relationships with company stakeholders, ... fostering effective collaboration with Regulatory Affairs (RA), Supply Chain, and HQ colleagues to ensure labeling compliance and accomplish company goals. Key Responsibilities Review and provide regulatory guidance on commercial labeling materials to ensure… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …impactful learning journeys. This includes proactively managing learning journeys within assigned areas of responsibility to enhance the skills within the therapy ... Essential Functions With alignment from the Associate Director to build assigned curricula & measurement strategies within (low-mid complex curriculum and/or asset… more
- Genmab (Plainsboro, NJ)
- …Tumors Strategy Lead. S/he will provide medical affairs leadership for assigned asset(s)/indications and support for the overall oncology solid tumor portfolio. ... meetings, congresses, and local symposia.Lead pre/peri/post launch medical activities for assigned asset(s) entering the US market.Collaborate with US Field Medical… more
- Genmab (Plainsboro, NJ)
- …Partner USBusiness Security Partner: Acts as security business partner for assigned business domains for new initiatives (POC), developments (MVPs), questions, and ... Partner JapanBusiness Security Partner: Acts as security business partner for assigned business domains for new initiatives (POC), developments (MVPs), questions,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Matrixed Team in defining and executing the global regulatory strategy for assigned programs to ensure timely and high-quality regulatory deliverables to the GPTs ... Lead health authority interactions, including leading team through creation of briefing materials and meeting preparation Lead and/or support global filing activities for submissions Present regulatory strategies including communication of regulatory risks and… more
- Genmab (Plainsboro, NJ)
- …Current operational finance capabilities are not matureOther responsibilities and projects assigned by the Director of Financial Planning & AnalysisRequirements A ... Bachelor's degree in a relevant discipline is required. A CPA/ MBA or other graduate degree is desired.8+ years of progressive experience in operational financeSAP and Adaptive experience a plusSolid understanding of generally accepted accounting principles… more
- Lundbeck (Philadelphia, PA)
- …(a) regularly meet/interact with customer base and internal personnel within assigned territory; and (b) typically attend 4-8 internal/external conferences and ... meetings spanning locations within the United States. Travel must be able to be completed in a timely manner. The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate's geographical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …needs and ensures commitments are delivered upon Uses knowledge of the assigned business function to identify business needs and develop value-added solutions ... Assists with identifying opportunities for enhancements and bug fixes Estimates effort accurately ahead of projects Uses all available vendor services and open sources to solve problems with code and applications Develops and maintains systems, applications… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and executed seamlessly Build strategic partnerships with external vendors, as assigned by the Director, to enhance event offerings and operational capabilities ... Follows up with clients to ensure satisfaction Reporting and Process Management Manage and report key metrics and data, preparing weekly, monthly, and quarterly reports for the Director, highlighting essential KPIs and performance indicators Oversee the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …interaction with FDA personnel, IT vendors and HQ colleagues regarding assigned projects and roles. Essential Functions Participates on cross-functional teams ... focused on the planning and execution of regulatory labeling operations. This includes anticipating labeling obstacles, identifying emerging issues and proactively developing solutions May participate in FDA submission planning meetings to ensure clear… more
- Genmab (Plainsboro, NJ)
- …at all times take the responsibilities of a CTM. If no CTM resource is assigned to a trial the GCTM takes on the CTM role too.ResponsibilitiesLead the Clinical Trial ... Team (CTT) and Trial Management (TM) teamDefine and align CTT goals collaboratively with the teamReview and approve protocol and amendment changesReview the Master Informed Consent Form (ICF)Approve operational plans, manuals, and charters for the trialOversee… more
- Legacy Treatment Services (Hainesport, NJ)
- …Year Degree Job Shift Day The Performance Improvement Specialist conducts assigned tasks associated with agency Performance Improvement and Risk Management ... and risk management purposes; maintains up to date databases assigned + Participates with assigned agency inspections...to date databases assigned + Participates with assigned agency inspections and COA site visits; assist with… more
