James Hilferty Email & Phone Number

Ventnor City, Nj, Us

Ventnor City, Nj, Us

Horsham, Pa, Us

Lead the Life Sciences Product Management Team, driving innovative transformation and operational excellence in support of global regulatory compliance within Life Sciences

Waltham, Massachusetts, Us

Led a multi-million-dollar business unit responsible for managing and growing the Regulatory domain.Provided subject matter expertise regarding the life science technology and services market to the executive team and board members. Analyzed product and services portfolio, addressable market segments, and competitive landscape and determined domain, product and services capabilities, and defined market positioning strategy. Enhanced market visibility through thought leadership, improving quality, and launching new products and pricing models. Elevated product vision, increased client satisfaction, aligned products and positioning to targeted markets, and expanded the addressable market. Defined business model, vision, and strategy, product roadmap, use-cases, and go-to-market messaging to support growth objectives.Supported marketing and commercial organizations to increase product and services up-sell, cross-sell, and new logo opportunity win ratios for the domain.Partnered with and acquired companies that accelerated the strategic roadmap supported the objectives of increasing addressable market, pipeline, client base, geographical footprint, product and services portfolio, scalability, revenue, and profitability.Executive sponsor for domain’s client and partner relationships and services projects.

Nottingham, Gb

Managed the Calyx Regulatory product portfolio. Created the strategic roadmap, initiatives, epics, and prioritized development activities.Met regularly with clients, analysts, industry leaders, and internal stakeholders to validate and communicate our product vision and roadmap, define market problems, and prioritize product and services solutions.Prepared and maintained business plans to enhance the portfolio of products and services that included financial models, risk assessments, communication plans, training plans, go-to-market activities, KPIs, post-launch strategies, and voice of the customer initiatives.Partnered with Microsoft to transition on-prem software products to cloud SaaS hosted in Azure.

Durham, North Carolina, Us

Managed Liquent InSight Regulatory platform and product portfolio of desktop Smart tools.

Durham, North Carolina, Us

Ensured consistency across projects in program, provided oversight to a project lead team, managed senior stakeholders internally and externally, maintained oversight and ensured accountability is retained within each project by the project leads.

Durham, North Carolina, Us

Identified client problems and developed creative solutions for projects and programs that leveraged organizational expertise, operational capabilities, and technologies.

Durham, North Carolina, Us

Managed the global technical operations team supporting the Regulatory Outsourcing Services business unit. Maintained systems and software in a validated state and supported client audits. Provided day to day business process analysis, system and process management, and articulated procedures, issues, and solutions to multi-level teams.

Horsham, Pennsylvania, Us

Designed and implemented SAP ByDesign finance system project and task coding for general accounting, project tracking and billing, and the design and generation of project and key performance indicator reports. Designed and implemented regulatory processes to support additional services business development.

Horsham, Pennsylvania, Us

Created and managed validation source books for Liquent regulatory products and provided regulatory assistance and technical support for a wide range of issues associated with document management and submission publishing. Designed and developed authoring macro suite (SmartScribe/SmartDesk) to format and prepare regulatory documents.

Horsham, Pennsylvania, Us

Compiled electronic and paper dossiers for clients in accordance with agency guidelines, developed companywide document management and publishing standards, best practices, and processes, and worked closely with internal and external teams providing training on new tools, systems and processes.

Compiled electronic and paper dossiers for clients in accordance with agency guidelines, design and developed authoring macro suite (Starting Point) to format and prepare regulatory documents, and authored company SOPs, guidance, work instructions, and policy documents.

Us

Administrated, supported, and maintained the publishing application, document management system, related databases, customized templates, and UNIX and NT servers. Supported Publishing Associates and their daily operations, which included troubleshooting: MS Office and Windows, Documentum Workspace, Liquent CoreDossier, authoring templates and macros, and validated workflow processes.