- Novo Nordisk Inc. (Plainsboro, NJ)
- …and documented immersion in social media Experience sourcing and managing content development and publishing Subject matter expertise: In-depth knowledge ... the confidence to take the lead and guide other employees when necessary (ie: content development , creation and editing of content , and online reputation… more
- Merck & Co. (Rahway, NJ)
- …Head in the Atherosclerosis & Metabolism Therapeutic Area within Global Clinical Development will focus on driving strategy, development , and life-cycle ... Steatohepatitis (MASH).The individual will be responsible for overseeing Product Development Team Leaders and-Clinical Directors within their group to ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oversight of the OEDC fellowship program through partnerships with academic institutions, content development for the OEDC website, and participation in the ... areas centered around rare diseases and immune disorders. Summary The Oncology Early Development Center (OEDC) Program Lead, who directly reports to the Head of the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWithin the Development Sciences and Clinical Supply (DSCS) organization, the Digital Program Manager will advance the purpose and aspiration of our ... the Digital Strategy for our organization, comprising of Process Research & Development , Analytical Research & Development , and Pharmaceutical Sciences &… more
- CHRISTUS Health (La Cienga, NM)
- …environment to obtain most recent evidence-based practices while enabling delivery of content to targeted groups. Clinical Education Specialists plan, design, ... New Mexico registered nurse license required, ANCC certification in Nursing Continuing Education /Staff development preferred and required within 2 years. BLS… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Conduct desktop research of the medical literature Assist in the development of medical information resources for Health Care Professionals and patients ... review of medical information resources Provide project management support Education /Experience: Qualified candidates must currently be enrolled in an accredited… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads the development and maintenance of the CCDS, US and EU labeling, and manages ... EU SmPC, EU PL, CCDS, CCPL)for new products or products in the development phase. Independently lead cross functional teams through all labeling discussions with the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads the development and maintenance of the CCDS, US and EU labeling, and manages ... EU SmPC, EU PL, CCDS, CCPL)for new products or products in the development phase. Independently lead cross functional teams through all labeling discussions with the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and approve all UAT crips and the implementation of new features. - Training Education - Manage the design and development of a comprehensive training program for ... and IT solutions. This position is responsible for overseeing the development , implementation, and maintenance of software systems that support business operations… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development ... Medical Director will also assist the Senior Medical Director in the development and execution of strategic priorities within a therapeutic area, including… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with contract manufacturing organizations CMO. This position develops strategy, prepares content templates and leads technical teams in preparation of submission ... some complexity. This position makes decisions with consultation. Responsibilities:Planning for Development : Manages multiple CMC development projects. Leads… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …writing assignments (external, internal and social media) and other tasks related to content development Support the updating and development of ... rules and regulations that apply to pharmaceutical companies' communications. Education /Experience: Excellent verbal and written communication skillsProficiency in Microsoft… more
- Merck & Co. (North Wales, PA)
- …DescriptionThe Regulatory Affairs Headquarters Principal Scientist is responsible for development and implementation of global regulatory strategy for their assigned ... regulatory agencies for multiple indications simultaneously.Provides expert advice to Product Development Teams and subsidiaries on regulatory issues as they arise… more
- Merck & Co. (North Wales, PA)
- …and audience needs and requirements of home country of expert(s), oversees the development of planning documentation and program content , and supervises the ... is a member of the GEMS Consulting & Medical Education team within, V&I Global Medical and Value Capabilities...with V&I GMSA or other stakeholders to ensure appropriate development of agendas and discussion guides, selection of appropriate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in collaboration with the other authoring functions- Accountable for Protocol content /study design development - Contributes from a medical strategy standpoint ... disorders.Summary The Senior Director sits within Global Oncology Clinical Development , an organization dedicated to the effective strategy, design, execution,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development , an organization dedicated to the effective strategy, design, execution, ... for coding of AEs, medical history, and medications when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late-Stage Development Portfolio. The individual will play a key role in making Precision ... the guidance of the CDx portfolio leader, covering all areas from CDx assay development through CDx approval and launch. May act as CDx representative to GPT for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity including post marketing projects and those involving 3rd party development . This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) ... may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU....US and EU package inserts with regard to both content and format. Follows internal processes for record keeping… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Summary The Manager, Clinical Data Standards is responsible for the development and sustainability of the Global Clinical Data Standards for quality ... Daiichi Sankyo R&D pipeline by managing activities associated with standards development , management, and implementations for DS Therapeutic areas. This position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents supporting GLP/non-GLP/ Research submissions to ... global regulatory authority requirements, and industry best practices.Ensure /support the development of GLP/GCLP systems, risk management processes such as SOPs for… more
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