- 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
- 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
- Eisai, Inc (Nutley, NJ)
- …and communication skills (both written and verbal).Demonstrated ability to lead global project teams to deliver projects across therapeutic areas, preferably in ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...support of staff. Some travel may be required for project management and/or business development.The incumbent is expected to… 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
- Merck & Co. (North Wales, PA)
- …includes, but is not limited to: Reporting to Senior Management of the Medical Device and Combination Product (MDCP) Quality Assurance Operations team, the Associate ... Director Quality Engineering & Quality Assurance is responsible for...Quality Assurance is responsible for independent compliance support of Medical Devices including the device constituent part of Combination… 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 programThis 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 programsThe CS… 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 ... strategic leadership for all statistical programming activity related to study, project and submissionManage CRO to ensure high quality compound and multi-compound… 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 ... as main statistical contact for the assigned studies and projects . Provides guidance to study team on all aspects...globally by providing input for the interaction or by writing the interaction document. May participate in meeting or… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Contracting Operations and Reimbursement (PCOR) Account Management, the SME for Medical Review Committee, Compliance, Legal, Personal Promotion, and other HCP ... for use by downstream programs/users. Relationships This role reports to the Director of Master Data Management within the Data Strategy and Execution Master/Data… more
- Novo Nordisk Inc. (Durham, NC)
- …the world, driving the stability portfolio for all products, and writing and maintaining regulatory documentation. Relationships Director . Essential Functions ... 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases,...successful execution of support to the productions Coordinate with Director , Bulk, Pack, QC & EM & other teams… more
- Novo Nordisk (Princeton, NJ)
- …in a clear, concise format + Can identify and resolve complex problems related to Medical Writing projects , processes, or tasks, with management support as ... The Associate Director is an expert in medical writing and performs work independently with...optimize the way we work and increase awareness of medical writing within the project … more
- IQVIA (Durham, NC)
- **Job Overview:** As a Lead Medical Writer on most types of writing projects . You will prepare assigned documents in accordance with IQVIA Standard Operating ... as to the agreed timelines. Perform Senior Review of straightforward medical writing deliverables. Negotiate timelines and discusses/resolves customer comments.… more
- BeiGene (Emeryville, CA)
- **General Description:** **Responsible for leading clinical regulatory medical writing activities for BeiGene that conform to domestic and/or international ... members of the MW LT to develop and maintain medical writing processes, standards, and tools (eg,...with others in high-pressure situations; a team player.** **Strong project management and leadership skills.** **Experience in writing… more
- Novo Nordisk (Lexington, MA)
- …data in a clear, concise format + Can identify and resolve problems related to Medical Writing projects , processes, or tasks, with management support as ... Medical Writer (MW) reports to an Associate Director of Medical Writing . The...project (s) + Leads meetings and drives decisions concerning project /trial-specific medical writing issues +… more
