ful travel based on client and business needs. Expect 30 50% travel What We Offer At BCG, we care about our people, and offer best in class benefits to support you personally and professionally throughout your different life experiences including An opportunity to work organically across disciplines and across BCG, we offer a unified and unrivaled opportunity that combines

Prepares /oversees the preparation of various regulatory submissions including Pre Submissions, 510(k) submissions, CLIA Waiver Applications, Dual 510(k)/Waiver by Applications, technical files, and license applications. Monitors new and changing regulations and guidance and disseminates information to stakeholders. Identifies regulatory trends and conducts key regulatory

Review all SpeakUp reports to identify emerging trends and create and implement relevant risk mitigation plans; Conduct or oversee internal investigations for the global organization from intake to closure; Supervise regional compliance investigators and other internal and external compliance resources as they conduct investigations. Advise on and, where appropriate, mana

/JOB PURPOSE Manages all regulatory activities for new development programs, pre IND through BLA/NDA and post approval. Responsible for developing and implementing global regulatory strategies encompassing clinical, non clinical and CMC disciplines. Provides expertise in translating regulatory requirements into practical, workable plans. Essential Duties And Responsibiliti

When you join Verizon Verizon is one of the world's leading providers of technology and communications services, transforming the way we connect around the world. We're a human network that reaches across the globe and works behind the scenes. We anticipate, lead, and believe that listening is where learning begins. In crisis and in celebration, we come together lifting u

Develop solutions to improve processes for global regulatory submissions. Identify, implement, support validation and manage software tools for organizing regulatory files, registration tracking and documentation for submissions Manage Regulatory tools/database and new enhancements. Interact with global regulatory leaders and peers to share and manage department metrics a

The Trademark Analyst serves as a subject matter expert internally and externally on all trademark matters related to both verbal and visual branding. This role is responsible for screening both name and logo candidates and clearly articulating rationale to internal and client teams. This role is the cornerstone of our VETT process and must be confident in all steps of th

Consulting Associate Capital Excellence Job ID 87922 Who You'll Work With You will be working with McKinsey's Capital Excellence service line in North America. Our Capital Excellence service line assists our clients in solving the world's toughest problems. Blending strategic thinking with hands on practicality, our team of consultants and experts work to develop and impl

Reviews and interprets regulations/guidance documents to develop regulatory strategy to support Transfusion Medicine project teams in terms of regulatory submission pathway, IND & CMC strategies, submission requirements, timing and risks. Interact with US FDA and acts as a liason with Corporate International RA and/or country RA to define submission content, expedite pend

The role is a technical lead that requires deep knowledge, skills, and experience in designing and carrying out clinical analytics. The position is a key team member collaborating in a multi disciplinary business environment with colleagues across the enterprise to lead clinical performance analytics, development, and reporting that deliver actionable clinical insights to

Manage applications to the FDA for Certificates to Foreign Government (CFG), and Export Certificates. Review, approve and submit FDA invoices, FDA submission check requests and FDA forms. Manage requests for regulatory document apostilles and legalization services. Manage Regulatory calendar for the RA team and leadership. Provide awareness of team meetings, holidays, lea

The role is a technical lead that requires deep knowledge, skills, and experience in designing and carrying out clinical analytics. The position is a key team member collaborating in a multi disciplinary business environment with colleagues across the enterprise to lead clinical performance analytics, development, and reporting that deliver actionable clinical insights to

/JOB PURPOSE Responsible for managing and maintaining existing investigational new drug (IND) and clinical trial application (CTA) submissions and preparing amendments in compliance with guidelines and regulations. Coordinates, compiles, and tracks product applications to regulatory agencies. Essential Duties And Responsibilities Review clinical site regulatory documents t

Grow the planning practice in the Northeast/New York metro region and mentor staff. Lead business development activities, including developing and networking with clients, preparing planning strategies for proposals and contracts, and supporting regional market leaders in the real estate, institutional, state and local government, transportation, and energy markets. Devel

The role is a technical lead that requires deep knowledge, skills, and experience in designing and carrying out clinical analytics. The position is a key team member collaborating in a multi disciplinary business environment with colleagues across the enterprise to lead clinical performance analytics, development, and reporting that deliver actionable clinical insights to