- 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
- 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
- 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)
- …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
- 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
- Tris Pharma (Monmouth Junction, NJ)
- …level for execution globally across the medical community and within each assigned territory. She/he also develops relationships with Key Opinion Leaders (KOLs) and ... other industry stakeholders to educate and provide valuable insights. The incumbent provides MSLs guidance, coaching and mentoring through regular communications, field visits, documented feedback and performance reviews.The Head, MSLs / Director, Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads the development and maintenance of the ... EU labeling, and manages the review of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with all applicable Health Authority (HA)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Leads, External Partner Quality Leads, and Business Partner Quality Leads based on assigned programs and in close collaboration with R&D Quality team members to ... Audits and Compliance function to ensure compliance with programs assigned and support the creation of lessons learned from...address any such gaps and learnings identified. May be assigned to support GSOP activities including the review as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Coding is accountable for delivery of medical coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, ... manage multiple programs concurrently. This position will manage coding resources of assigned studies. This position requires a strong working knowledge of medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …address labeling issues for late stage projects. This position manages multiple assigned projects of increased complexity including post marketing projects and those ... leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance of global labeling and associated… more
