- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary: The Associate Director , Regional Marketing Conventions & Field Programs will be responsible for ... more, while ensuring adherence to DS policies and procedures. The Associate Director , Regional Marketing Conventions & Field Programs is responsible for managing the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director , Program Management is a senior position responsible for effectively ... a wide range of functions in Daiichi Sankyo (DS). Reporting to the Sr. Director , Enterprise Program Management , this position requires a capable leader with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategize and plan for FDA meetings as needed. Acts as ... point of contact for cross-functional teams on RA labeling issues . Collaborate with Regulatory Affairs and Labeling colleagues in other regions, including Japan,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …plans for specific categories under the direction of the head of category management , for the creation, execution, tracking of strategies. Includes working under a ... in managing multiple complex and competing priorities simultaneously. Proven project management and strategy skills. Is experienced in leading complex initiatives of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …acceptance testing to ensure expected results and troubleshoot any identified system issues .Lead and participate in regular system release management and testing ... as the principal functional expert and advisor for implementation and ongoing management and maintenance of the Company's global HRIS system (ie, SAP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …programs, in order to proactively perform safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and ... PSL(s) to proactively plan and prioritize safety surveillance and risk management activities for assigned product(s), including resource planning, oversees team's… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …respect to budget, timeline, achievement of defined milestones and overall project risk management . He/she will assess project issues and develop resolutions to ... escalate to Senior CMC Lead regarding the activity status and potential critical issues , or to the governance bodies. Responsibilities - Accountability to lead teams… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting to the Director , Asset Management & Reliability, in this role as Associate Director Asset Management & Reliability CoE, you will ... within a designated region in the Manufacturing Division.As Associate Director of Asset Management & Reliability CoE...business performance measures related to functional, quality, and cost issues .We are proud to be a company that embraces… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and industry best practices.Ensure /support the development of GLP/GCLP systems, risk management processes such as SOPs for QA activities for internal and external ... FDA, ICH, EMA, PMDA regulations/ standards and guidance.Identify QA compliance issues pertinent to GLP/GCLP activities, implementing solutions and partnering with… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …point of contact to cross-functional teams on US/EU RA CMC project issues .Execution of Strategy and Submissions: Develops strategy with supervision. Prepares content ... direct or related CMC regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionA fantastic opportunity has arisen for an Associate Director Asset Management & Reliability CoE.Reporting to the Director , Asset Management ... in this role as Associate Director Asset Management & Reliability CoE, you will be responsible for...business performance measures related to functional, quality, and cost issues .As a company, we are committed to 'Inventing for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …end-to-end: understanding predisposing non-clinical and clinical factors, diagnosis, effective management during clinical trials and beyond in post approval ... key safety initiatives aimed at preventing, mitigating, and addressing critical safety issues including but not limited to protocol amendments, Dear HCP letters and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages multiple assigned projects of increased ... as point of contact for cross-functional teams on global labeling issues . Based on timelines or resources, may assist another Global Labeling… more
- Merck & Co. (Rahway, NJ)
- …strategy, market development, thought leader engagement, competitive dynamics, issues management , forecasting, opportunity valuations, resource requirements, ... Job DescriptionWe are currently recruiting for a Global Marketing Director for metastatic lung cancers. Our Marketing team is passionate about bringing our medicines… more
- Merck & Co. (Rahway, NJ)
- …anticipating, and adjusting for obstacles and setbacks, and elevating complex issues to the appropriate management level.--Participates in the recruitment, ... to cross-functionally.-Displays collaborative approach in problem solving, governance, change management and appropriately synthesizes key business information to … more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description: Director (M3), Analytical External Capabilities, Validation & Compliance (ECVC).The selected candidate will work in the Analytical ... analytical method qualifications/transfers, technical oversight, and resolution of analytical issues .Oversee analytical capability build at selected external partners by… more
- Merck & Co. (New York, NY)
- …contact within the company.Addresses scientific questions and directs SL inquiries on issues outside of Regional Medical Scientific Director 's scope (eg, grants) ... Job DescriptionRole SummaryThe Cardiovascular & Metabolism Regional Medical Scientific Director is a credentialed (ie, PhD, PharmD, DNP, MD) therapeutic and disease… more
- Merck & Co. (Rahway, NJ)
- …products related to Experience Design, UX/UI, User Research, and Technical Product Management relevant to our company user environment.- Partner with Product teams ... design and user-centric research and usability studies, and applying change management approaches to understand user needs and deliver results Manage, monitor… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director of Quality Project Management and Strategyas part of the ... Quality team based in Raritan, NJ. Role OverviewThe Associate Director of Quality Project Management and Strategy role is an exempt level position with… more
