Showing 13 jobs

...and rankings, such as Gartner Magic Quadrants, IDC MarketScapes, and Frost & Sullivan Radars, by managing timelines, submissions, and strategic analyst engagement and follow-up. • Analyze and synthesize analyst feedback and published reports to provide actionable insights for marketing, product strategy, and executive decision-making.

...Brainstorms new project ideas to present to potential authors • Serves as primary point of contact for academic proposal submissions • Coordinates with the Publisher to garner team feedback on promising proposals • Presents proposals to the pub board meeting • Negotiates contract terms with authors and submits contract requests...

...Commercial and other key stakeholders Filing / Regulatory • Represent Medical Affairs in development of regulatory documents and submissions (e.g. briefing books, protocols, label discussions etc.) • Represent Medical Affairs at FDA/EMA meetings Integrated Evidence Package • Leads the Integrated Evidence Team for development...

• Lead clinical contributions to pre-IND and IND submissions (and other stage-appropriate Regulatory submissions) • Lead clinical contributions to Phase 1 study protocols and trial- related documents. • Serve as Medical Monitor on Phase 1 trials.

...underwriting guidelines, research, and manage emerging issues and assess business opportunities and prospective insured submissions. • Maintain existing value-added services or develop new services to meet customer expectations • Provide marketing support including materials and presentations and make point of sale presentations...

...ICH) to product quality, staying abreast of changes and advising stakeholders appropriately • Review and author regulatory submissions sections and provide input to ensure clarity and consistency of messaging across Quality owned sections • Responsible for the review and approval of Annual Product Review for represented commercial...

...timelines to meet global regulatory requirements for adverse event reporting and data exchange obligations • Oversee regulatory submissions for ICSRs from the Global Safety database, on-time delivery of adverse event reports to global Health Authorities, alliance partners, including SUSAR and SAE communication to Ethic Committees...

...Contribute to Underwriting guidelines, research, manage emerging issues and assess business opportunities and prospective insured submissions. • Maintain existing value-added services or develop new services to meet customer expectations. • Provide marketing support including materials and presentations.

...implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts. • Follow FDA submission requirements in consideration of BARDA Program Divisions and the regulatory operational requirements of BARDA core services including clinical, nonclinical, and manufacturing network services.

• Ensure regulatory processes and guidelines are followed, includingco-authoring, and reviewing regulatory submissions to the US Food and Drug Administration (FDA) • Author, review, develop Request for Task Orders (RTORs) and evaluate Clinical Research Organization (CRO) proposals.

Assists PIs with non-financial report submissions, as necessary. Coordinates and submits requests for No Cost Extensions, Carryover, rebudgeting requests, changes in scope, and other changes to the award; ensures all requests are done in compliance with sponsor guidelines and institutional policies.

...an understanding of all types of non-clinical studies and how this data fits into overall vaccine development, regulatory submissions, and licensure • Strong expertise in animal models, animal ethics policies, experience with US FDA Animal Rule, non-clinical immunology, correlates of protection, mode of action and safety; experience...

• Review supported industry partner submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications, etc. • Monitor supported industry partner project timelines for FDA submission. • Participate or act as regulatory representative on various cross-functional teams, as assigned.