Bernie Coney

About Bernie Coney

Key Skills & Experience:Technology delivery in Regulatory Affairs and Healthcare delivery systems, e.g. Planning and Tracking, Agency Submissions, Labeling and enterprise Content Management.Process Development, organizational design and technology implementation for Global organizations.Content Management, Document Management, Regulatory Planning, Tracking and Translation Management and Localization.Mergers and Acquisitions experience, integrations and divestitures within both sides of an acquisition.Business Partnering experience for IT, delivering solutions to Pharma/Biotech companies. Global Labeling experience, managing Labeling submissions and delivery of US (SPL), EU, Regional labeling and Company Core Data Sheets.Change Management. User Adoption and Communication lead for a number of large Technology projects. Program Management. Strong communication skills, written and oral, workshop facilitation.Specialties: academic, adobe acrobat, business process, change management, content management, information management, data migration, database administration, document management, submissions management, IDMP, documentum, management, packaging, performance analysis, process engineering, project management, proposal writing, quality, requirements, strategic, communication, training programs, translation, writing, xml.

Experience

1. Principal Consultant

   NNIT

   Nov 2019 — Present · Princeton, NJ, US

   Responsible for strategic leadership for all labeling and user content of medical products for global markets; accountable for content, visual design and implementation of product labeling across product packaging, Instructions for Use (IFU’s), and user assistance communication. Functional management for Content Development and Labeling teams for Immunoassays and Clinical Chemistry/Specialty Assays, supporting the Laboratory Diagnostics Business.Strategic vision and harmonization of practice, delivery and digital transformations across Siemens Healthineers R&D and Commercialization as it relates to Product Information. • Plans and directs practices and resources to support content development, review, localization and delivery activities supporting the diagnostic product life cycle; providing development strategies, resource planning and budgeting, and reporting status to the Business. • Leads and directs the work of managers and developers, including external business partners.• Acts as primary interface with Product Life cycle Management leadership in all business initiatives affecting product labeling and customer documentation.• Responsible for maintaining excellent collaborative relationships with R&D, Product Marketing, Regulatory/Quality and other business functions.• Collaborates with usability specialists and customer facing functions to drive excellence in content and design usability.• Accountable for selection and implementation of tools and processes needed to support group practices.

Education

• University of Pittsburgh

  MA, English

  2001 — 2003

• Temple University

  BA, English

  1995 — 1999

Skills

• Change Control
• Gxp
• Pharmaceutics
• Technical Writing
• Clinical Trials
• U.s. Title 21 Cfr Part 11 Regulation
• Adobe Acrobat
• Gmp
• Microsoft Word
• CRO
• Database Administration
• Copy Editing
• Standard Operating Procedure (Sop)
• Content Management
• Documentum
• Regulatory Requirements
• Pharmaceutical Industry
• Sop
• Fda
• Xml
• Drug Development
• Gcp
• Biopharmaceuticals
• Document Management
• 21 Cfr Part 11
• Word
• Good Clinical Practice (Gcp)
• Requirements Analysis
• Validation
• U.s. Food and Drug Administration (Fda)
• Clinical Development
• Process Engineering
• CRO Management
• Regulatory Affairs
• Business Process
• Editing
• Capa
• Proofreading
• Computer System Validation
• Strategy