- Novo Nordisk Inc. (Plainsboro, NJ)
- …and mentoring to other members of the Medical Writing team. Relationships The Director Medical Writing ( Director ) reports to a Senior Director ... and performs work independently with minimal-to-no supervision. The Director will work closely with cross-functional project ...operations Can identify and resolve complex problems related to Medical Writing projects , processes, or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …department and relevant project (s) Can identify and resolve problems related to Medical Writing projects , processes, or tasks, with management support as ... The Senior Medical Writer reports to a Director of Medical Writing . The...meetings, drives discussions, and ensures decisions are taken concerning project /trial-specific medical writing issues Resolves… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … and oversee the work of support staff that will assist in the project execution and management of specific research projects . May supervise junior market ... that will assist in the development of commercial strategies Excellent writing , presentation, project management and strong influencing skills required.… more
- Eisai, Inc (NJ)
- …preparing PCS, protocols, and protocol amendments often acting as the compound leadLead project management for medical writing deliverable by defining ... this is your profile, we want to hear from you. Job Summary The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... alignment with key global and regional functions. The Global Director of HEOR & RWE Oncology will lead the...and visible expert leader, he/she will engage the clinical, Medical Affairs and commercial organization and drive the product… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …role, the incumbent will help develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support the ... the VP Medical /Scientific Development, Clinical Operations, Non-Clinical Research, Medical Writing , Program Management, CMC and Regulatory Affairs teams.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical research, clinical science, and/or CQA). Strong experience in procedural writing and maintenance, process improvement, and project management a ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Merck & Co. (North Wales, PA)
- …and approaches across geographies.Under direction of the Executive Director , Companion Diagnostics/In Vitro Diagnostics, the Principal Scientist/ Director ... strategic and tactical CDx/IVD regulatory guidance that positively influences project planning and decision making.-Developing regulatory strategies for assigned… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... components of a large-scale global clinical program using strong clinical project and program management, leadership, decision-making ability, people management, and… more
- Eisai, Inc (Nutley, NJ)
- …of neurodegenerative disorders, eg, Alzheimer's disease and dementia, and other projects .Collaborate with cross-functional partners to meet project deliverables ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...related to Alzheimer's disease (AD) dementia and various other projects . In this capacity, you will engage in collaborative… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and amendmentsLead document review and coordination for the protocol and amendments. Additional medical writing tasks may involve ICF, CRF guidelines, IB and ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will ... are managing a team of clinical scientists for the writing of protocols / amendments and associated documents (...clinical data and Clinical Study Reports (CSRs)/outputs throughout the project life cycle is optimized across multiple programs. The… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... SummaryProvide strategic leadership for all statistical programming activity related to study, project and submission. Manage CRO to ensure high quality compound and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …implementation of sourcing strategies for a specific set of R&D categories (CRO, Medical Writing , BDM, etc..). Builds strategic plans for specific categories ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... Provide strategic leadership for all statistical programming activity related to study, project and submission. Manage CRO to ensure high quality compound and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in due-diligence activities, and represents global function on study and project teamsProduces independent writing for publications and regulatory ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...support Phase 2/3 studies, represent function on study and project teams, and participate in and contribute to regulatory… more
- Insmed Incorporated (Bridgewater, NJ)
- …Research groups. The role will provide scientific and strategic guidance to global project teams and will oversee the internal and CRO resources as they relate ... to TBS.ResponsibilitiesLead projects , provide oversight of outsourced GxP bioanalytical validations and sample analysis from early to late development for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... Science function. This position may be at the executive director level or senior director level, depending...trials from the clinical science perspective, and ensure the writing of high quality clinical trial protocols, review of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …take a document review & coordination role for the protocol and amendments. Additional medical writing tasks may involve ICF, CRF guidelines, IB and safety ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and amendments.Lead document review & coordination for the protocol and amendments. Additional medical writing tasks may involve ICF, CRF guidelines, IB and ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
