- Insmed Incorporated (NJ)
- …and planned trials, management of third-party vendors for clinical services, management of project timelines and deliverables. Key trial management ... of patient profiles and data listings.Proactively identifies potential resource needs to management .Participates in the development and review of department SOPs… more
- Novo Nordisk Inc. (Seattle, WA)
- …required Demonstrated excellence in leadership, strategic influencing, initiative ability, project management , internal and external relationship development, ... flexibility in technical expertise across disease areas preferred Experience in account management and/or project management preferred Expert technical depth… more
- Insmed Incorporated (San Diego, CA)
- …and support to ensure Insmed computerized systems are deployed following lifecycle management and remain in a validated state per associated SOPs, regulatory and ... and operational efficiency of validated systems through participating in release management , change control, periodic reviews, and audit trail reviews. \tOnsite at… more
- Insmed Incorporated (NJ)
- …guidance and support to ensure Insmed computerized systems are deployed following lifecycle management and remain in a validated state (eg SDLC, IT Change Control) ... and operational efficiency of validated systems through participating in release management , change control, periodic reviews, and audit trail reviews.What You'll… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Management Process for the respective business areas.Responsibilities:Leadership and Project Management :Lead the end-to-end quality execution across Medical ... Medical Affairs QA to conduct quality reviews of product profiles, ensuring thorough management review of all quality and compliance topics, including Key… more
- Merck & Co. (Rahway, NJ)
- …and other teams and the ability to successfully work across geographic boundaries. Project management , including the ability to adapt to changing priorities ... Cross-Functional Teamwork, Detail-Oriented, Name Development, Process Improvements, Professional Presentation, Project Management , Regulatory Compliance, Strategic PlanningPreferred Skills:… more
- Merck & Co. (North Wales, PA)
- …Acumen, Interpersonal Relationships, IS Audit, Managing Distribution Channels, Market Access Strategies, Market Management , Pharmacy Benefits Management ... (NCOSC), which delivers end-to-end services that enable affordable patient access , deliver insightful customer experiences, and support enriching employee… more
- Capital One (New York, NY)
- …years of experience in information technology (operations, software delivery, access management , microservices), information security (application security, ... the effectiveness of existing controls, identify and define issues, review and analyze evidence, and document client processes and...least 4 years of experience in managing audit engagements, project management or a combination At least… more
- Eisai, Inc (Boston, MA)
- …& Business Agility, Customer Engagement, Industry & Regulatory (Market Access ), Mentoring/ People Development, Project ManagementEisai Salary Transparency ... channels.The Regional Account Executive will be responsible for creating and maintaining access to Eisai's product portfolio in all assigned regional payer accounts… more
- Cipla (Hauppauge, NY)
- …batch record review process, particularly in relation to audit trail management and data integrity. Ensure completion of individual training assigned and follow ... supporting manufacturing processes, with a particular focus on audit trail review , data integrity, and overall GxP compliance. Responsibilities: Perform detailed… more
- Insmed Incorporated (NJ)
- …and support to ensure Insmed computerized systems are deployed following lifecycle management and remain in a validated state per associated SOPs, regulatory and ... and operational efficiency of validated systems through participating in release management , change control, periodic reviews, and audit trail reviews.What You'll… more
- Insmed Incorporated (NJ)
- …of the functions and processes relevant to drug development, and project management principles applicable to the biopharmaceutical environment!Extensive ... strategic supplier relationships, lead vendor selection, performance monitoring, business review governance, and continuous improvement reviewsEstablish and maintain KPIs,… more
- Insmed Incorporated (NJ)
- …fiberboard)Plastic bottles/Glass vialsFlexible PackagingLabelingPatient KitsThermoformed PackagingExcellent project management skillsHigh interpersonal skills ... projects to assure they meet quality and consumer expectations while maintaining project schedule and budgets. Under limited manager supervision, the individual will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …, category management , process and continuous improvement expertise, project management and supplier performance measurement skills required- Procurement ... benefit the stakeholders, DSI and DS Group. Develops comprehensive global category management strategies to uncover strategic insights to help influence and inform… more
- BioAgilytix (San Diego, CA)
- …while also playing a key role in client engagement, project delivery, and cross-functional collaboration.Essential ResponsibilitiesLead team(s) developing and ... GxPs.Prioritizing tasks and managing schedules efficiently.Meet regularly with lab management to ensure instrument resources and employees are utilized effectively… more
- Insmed Incorporated (NJ)
- …manage multiple projects in a fast-paced environment Ability to problem-solve Strong project management skills Excellent verbal and written communication skills; ... technical guidance to Insmed programmers, contractors, and vendors around project conventions, standards, practices, and specifications to ensure integrated… more
- Insmed Incorporated (NJ)
- …programs. This role will provide regulatory input to global cross-functional project teams throughout product development and submission activities. The GRL will ... serve as the global regulatory lead for documentation review prepared by other technical functions and will act as the primary regulatory contact for the US FDA. The… more
- Insmed Incorporated (NJ)
- …Medical Writer is a REMOTE position, responsible for the development and management of medical writing deliverables, including but are not limited to protocols ... and ICH guidelines (including E3 and E6), and knowledge of document management systems; is capable of working independently with minimal supervision.What You'll Do:… more
- Novo Nordisk Inc. (Boston, MA)
- …while executing against immediate opportunities to drive performance Develops and utilizes project management skills to execute local initiatives Organizes work ... Internally, this position will collaborate with partners in Medical, Market Access , Marketing, and other Rare Disease affiliated teams. Essential Functions Drives… more
- Insmed Incorporated (NJ)
- …and systematic literature reviews.Build, mentor, and manage a high performing team. Review HEOR research project materials including study protocols, analysis ... engages and collaborates with stakeholders across the company including market access , marketing, medical affairs, and clinical development to understand and support… more
