- Merck & Co. (Rahway, NJ)
- …you will be part of the HHDDA Commercial Data Solutions team and lead Digital Product Management capabilities role, driving shaping and delivery of impactful ... across the HHDDA portfolio. In addition, you will also lead a team of highly talented individuals working on...team to manage life cycle of sales and marketing data product , including use case identification, discovery… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Regulatory Lead for asset to reach resolution.Participate in global product team meetings to provide US regulatory support and guidance as needed and ... matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing… more
- Merck & Co. (Rahway, NJ)
- …metrics, and user trends - Use data driven insights to d rive innovation through product discovery - Ability to influence and lead a team of direct and non- ... outcomes - Work closely with software engineers , UX designers, data engineers, quality engineers and other product teams and product leadership - Ability to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur HRM IT Product team operates as a business partner proposing ideas and innovative solutions that enable new capabilities in support of Regulatory ... to be more productive and enable innovation. We are looking for a detail-oriented- Product Analyst -to join us on a multiyear journey to stand-up, sustain and grow… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead , Product Safety Lead (PSL), Clinical Safety ... activities under the direction of Clinical Safety Scientist Product Lead .Develop expertise in one or more...and PSL or Clinical Safety Physician(s) to evaluate safety data of any source to identify potential safety signals,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead , Product Safety Lead (PSL), Clinical Safety ... activities under the direction of Clinical Safety Scientist Product Lead .Develop expertise in one or more...and PSL or Clinical Safety Physician(s) to evaluate safety data of any source to identify potential safety signals,… more
- Merck & Co. (Rahway, NJ)
- …introduction(s) and commercial market(s) approval(s).Define design input(s)/ output(s) and lead associated combination product design verification plan, ... studies at the device component/ subassembly/ in-process material and combination product level. Lead stablishing test methodologies/ testing readiness and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Mixed Modalities team within Sterile Product Development is responsible for developing parenteral dosage forms (injections, implants, inhaled, ... collaborate in a fast-paced multidisciplinary team environment. Primary Duties: Lead /contribute towards the new, innovative approaches for small molecule,… more
- Formation Bio (New York, NY)
- …drug development decisionmaking and workflows, tech/AI opportunities, and industry dynamics Process Lead Product team in effective discovery and research to ... best practices for Design productivity, quality, and cross-functional collaboration People Lead the Product Design team in delivering high-impact, high-quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for our Rare Disease/Specialty Medicine portfolio. SummaryThe Director, Clinical Safety, will be a product safety lead or part of a product safety team, ... this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics,… more
- Merck & Co. (Rahway, NJ)
- …rigorous scientific and ethical standards.-The Distinguished Scientist (Executive Director) and Product Development Team (PDT) lead , Oncology Global Clinical ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs...the field of breast cancer. The Executive Director, PDT lead will manage the entire cycle of clinical development,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the GCL, if applicableDelivers all relevant components needed for maintenance of product licenses (eg, Core Data Sheet generation/revision; clinical benefit-risk ... UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review Plan (IDRP)Accountable for the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders.SummaryThe Director, Clinical Safety, will be a product safety lead or part of a product safety team, ... this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position ... Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code, state and federal data privacy laws, and product liability laws) required7 or More Years ... goals as identified by senior management.ResponsibilitiesActs as a brand attorney and lead legal advisor for the commercial business and operations supporting US… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the New Product or Commercial Brand Teams, the Medical Affairs lead develops the medical/commercial strategy based on the scientific development and appropriate ... stages of commercialization.- For Oncology portfolio serve as the US Medical Affairs lead or Global lead in development committees and global medical affairs… more
- Merck & Co. (Rahway, NJ)
- …customers both internal and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the ... ogram (s) . The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stakeholders on important drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of Clinical Safety and risk ... for risk mitigation and oversees the global communication of important product safety information.Create and align processes that address global CSPV objectives… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Brand Lead , Neuroscience is responsible for driving the creation and execution of the early commercial strategy for our company's emerging ... This role works closely with R&D colleagues to define commercially viable product development and LCM strategies - either through internal efforts or business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .- Drug Development Strategy: Provides ... scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.- CRO / Vendor Oversight: Review CRO/vendor proposal and… more
