- Novo Nordisk Inc. (Plainsboro, NJ)
- …resolutions, and trends Collaborate with other departments to develop and implement risk mitigation strategies Lead the development and implementation of ... and development opportunities for team members. Qualifications Bachelor's degree in Business, Risk Management, or Information Technology, Data Analytics, or a… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & Clinical ... across regions and functional areas. The role of the Global Process Lead involves developing and maintaining efficient, effective, and compliant business standards,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and ... of systems development for global informatics systems, ETL and integrations. The Tech Lead must develop and implement informatics systems and programs to support the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for synergies between the products. When goals are tactically misaligned or at risk for these assets, this leader will be responsible for bringing the issue ... matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing… more
- Genmab (Plainsboro, NJ)
- … Information Security will report directly to the VP and Global Head of Information Security and IT Risk & Compliance, playing a strategic role in the ... several platforms.Primary ContactsReports to the VP, Global Head of Information Security and Risk & ComplianceSecurity Officers...Medical Affairs, VP Regulatory Affairs, GM Genmab US, IT Lead in Japan)Peers within IT&D, such as Leadership Team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. Job SummaryThe position develops the global safety strategy, oversees risk management activities, and recruits and develops staffing for at least ... 3/4 program.This position identifies and selects resources/tools to facilitate risk management during development and post-market. Additionally, this position… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and ... policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate will also… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …plans across functional teamsDefines the interdependent deliverables and ensures that quality, risk , cost, time are managed within the overall approved plan to drive ... criteria for the project.Develops options and solutions to complex project risk problems, providing guidance to leadership including trade-off and implications… more
- Merck & Co. (Rahway, NJ)
- …expertise.The Associate Director brings forward strong subject matter expertise to lead studies and evaluations, determine suitability, establish direction, conduct ... risk assessments, define safeguards, assess operability, interface with vendors,...guidance are preferred.- Candidate should have demonstrated ability to lead a cross functional team through design and execution,… more
- Merck & Co. (Rahway, NJ)
- …is seeking a highly motivated and technically focused individual to lead the Crystallization Lab. Through direct, lab-based contributions and scientific supervision ... a team of crystallization subject matter experts, the Crystallization Lab Lead collaborates with cross-functional teams to ensure small molecule Active… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the ... of product licenses (eg, Core Data Sheet generation/revision; clinical benefit- risk assessments for license renewals, responses to Health Authority)Participant and… more
- Merck & Co. (Rahway, NJ)
- …Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team that will build biopharmaceutics ... policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate will also… more
- Genmab (Plainsboro, NJ)
- …60% of the time per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy, Global Regulatory Affairs, the key responsibilities include ... This responsibility will involve collaboration with a partner. Evaluate regulatory risk and recommend mitigation strategies to ensure optimal regulatory success.… more
- Merck & Co. (Rahway, NJ)
- …and management of all aspects of a given project, accountable to gather information , create and maintain deliverables in Jira project with clear dependencies for ... challenges that arise in complex technology projects.Create and maintain PMO Risk , Issue, Decision logs, Jira advance roadmap and confluence.Tracks activities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …facilitation, and post-inspection-related activities under the supervision of the IMT Lead .Management Review: Collect the data and information needed to ... is in a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs), who are responsible for the delivery… more
- Merck & Co. (Rahway, NJ)
- …leverages significant depth and breadth of scientific and technical experience to lead small molecule drug substance process development teams to develop safe, ... following current Good Manufacturing Practices (cGMPs), and participating in risk assessments, deviation investigations, and Good Documentation Practices (GDPs).-A… more
- Genmab (Plainsboro, NJ)
- …CPQS in the Translational and Quantitative Sciences Leadership Team and lead strategic development of pre-clinical and clinical pharmacology strategies for Genmab's ... a culture of continuous learning and improvement.This is an exciting opportunity to lead a passionate, high profile, high-impact Pharmacology team, and work in a… more
- Merck & Co. (North Wales, PA)
- …for ensuring the clinical relevance and medical accuracy of data/ information in promotional materials, external communications and field-based employee training. ... required, interact with Health Care Provider to help answer unsolicited medical information requests. The Medical Consult and Review Physician provides medical and… more
- Merck & Co. (Rahway, NJ)
- …engage in new approaches to reach adults and parents of adolescents at risk for HPV-related cancers and diseases. Monitor the vaccines ecosystem and media ... to HPV vaccines and opportunities to position HPV in social discourse. Co- lead communications around expansion of current product portfolio and new product launches.… more
- Merck & Co. (Lower Gwynedd, PA)
- …and Translational Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within the Late Development (AdVAnce) Vaccines bioanalytical ... Township, PA.We are seeking a talented, organized, and innovative leader to lead our Laboratory Operations and System Validation team. The successful candidate will… more
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