- 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 ... We're changing lives for a living. Are you ready to make a difference?The Position The Director , Medical Writing is an expert in medical writing and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …requirements of a clinical program. Relationships The Senior Medical Writer reports to a Director of Medical Writing . The Senior Medical Writer is ... audience Initiates knowledge sharing and contributes to process improvements within the medical writing area Actively participates in relevant meetings, training… 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
- Eisai, Inc (NJ)
- …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 ... protocol amendments often acting as the compound leadLead project management for medical writing deliverable by defining milestones, managing budget, resources… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …actionable insights to guide the business. Relationships Reports to the Director , MAPA Insights. Internal relationships include close interactions with Market Access ... enterprise functions (Sales, Marketing Operations, Market Access, Pricing & Contract Ops, Medical , Legal) as well as global market research and brand teams. Drive… 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
- 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 ... areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Clinical Operations (GCO) Procedural Ownership and Life Cycle… 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 ... regulations on the development and registration activities for the respective medical products.-Providing regulatory support for due diligence activities, as needed.… 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 ... and guidelines, reviews and provides written assessments of relevant medical topics, and supports PV Operations' medical ...and relevant team members.Reports and Submissions: May contribute to writing minor safety sections of the NDA, CSR, 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 ... and labeling for drug and diagnostic products. Provides guidance on planning, writing , review of key dossier documents for submissions globally. Ensure high quality… 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 ... with the Head of Clinical Development Operations or Senior Director , Clinical Operations on plans for successful implementation of...the CRO through to study close out and CSR writing . Ensure the timing of the major study milestones… 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 ... CS Asset Leads who are managing a team of clinical scientists for the writing of protocols / amendments and associated documents ( writing of ICF, DM… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …documents (eg, response to HAs, briefing book, etc.) in conjunction with Medical Writing - Leads scientific components of IM (Investigators Meeting) 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)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... accelerated worldwide product submissions and approvals. Authors or initiates writing of global standard operating procedures for statistical programming practice,… 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 ... and represents global function on study and project teamsProduces independent writing for publications and regulatory documentsServes as a specialist in PK-PD… 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 ... accelerated worldwide product submissions and approvals. Authors or initiates writing of global standard operating procedures for statistical programming practice,… 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)
- …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
