- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head ... Directors, Managers, contractors as applicable) across the Global PV Quality teams located in Europe and the Americas. This...position is accountable to drive a proactive approach to quality and instilling a shared passion for building a… more
- Insmed Incorporated (Bridgewater, NJ)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director , Quality ... QC oversight activities for Insmed. He/she will be responsible for Quality related activities for commercial products including transition from development (Phase… more
- Catalent (Philadelphia, PA)
- Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality function is to build, monitor, and sustain a robust and effective quality ... Japanese, and Australian agencies and other international and/or local health authorities.The Director of Quality is responsible for providing leadership and … more
- Insmed Incorporated (Bridgewater, NJ)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of ... Pharmacovigilance QA serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other related… more
- Merck & Co. (North Wales, PA)
- …and Combination Product (MDCP) Quality Assurance Operations team, the Associate Director Quality Engineering & Quality Assurance is responsible for ... and other worldwide regulations and our Compa requirements.This position provides Device quality engineering and quality assurance support and leadership to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Global Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of both worlds to ... Are you ready to make a difference?The Position The Director , Medical Writing is an expert in medical writing...role will be a senior member of the Regulatory, Quality and Clinical Reporting (RQC) team, and will provide… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... difference? The Position The Associate Director , Medical Affairs Omnichannel Engagement, role is to support...Medical Affairs Omnichannel Engagement, role is to support the Director of Medical Affairs Omnichannel Engagement and SPOC department… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Medical Affairs (GMA) Oncology- Medical Content and Training works ... and GMA Oncology TA/franchise in developing and reviewing global high- quality medical information and training materials/programs, ensuring accuracy and scientific… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the development, maintenance, ... efficient data analysis and reporting.Promote Daiichi Sankyo values and quality workplace culture by nurturing collaboration in cross-functional and multicultural… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …review teams as well as with business partners to achieve high quality and accurate labeling in support of business objectives.ResponsibilitiesPreparation of new and ... with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes Process Best Practices: Serve as a role model… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.SummaryThe Associate Director (AD) is responsible for overseeing all activities related to Medical ... corporate communications and select medical material) is of the highest scientific quality and is compliant with all relevant policies, procedures, and regulations,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Global Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of both worlds to ... incumbent will help develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support the design and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... time throughout the annual performance cycle. Relationships Reports to Executive Director or Vice President Medical Affairs. Has direct supervisory responsibility… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with clinical and medical teams, CROs and other vendors to ensure high quality of coding deliverables to support drug development processes and global submissions. ... optimize medical coding processes, technology, and standards. This position ensures quality delivery of medical coding for clinical trials, clinical development, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study ... planning start-up, conduct, reporting and close out) including timeline, quality and budget. A key focus will be the...of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Director , Clinical Safety, will be a product safety lead or part of a ... external (especially regulatory, but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …assigned, ensuring onboarding of N-3 leaders directly reporting to the VP of Quality , and in close collaboration with the QA Training and Documentation management ... leader, however is also accountable to the VP of quality . The incumbent is expected to understand and apply...for Global RD/PV/MA QA relevant activities including QQR, monthly quality report, team building and management review.- Involve and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... difference? The Position The Scientific Director (SD) functions as a subject matter expert to...works closely with the TA Leadership Team and Medical Director team to identify and execute key projects in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval ... of pharmaceutical applications for the company's growth, thereby accomplishing corporate goals.Responsibilities:Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for FDA meetings.Serve as the primary contact with FDA and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes Processes and Best Practices: Reinforces labeling best ... practices at cross-functional meetings. Assists in the development of Standard Operating Procedures (SOPs) and process improvements. Follows agreements with external partners.Department Coordination: Builds cross-functional and cross-regional… more
