Ron Cornwell
Medway,MA
Summary
Project Management Professional with 20+ years of IT Systems experience as a Project and Program Manager in the Pharmaceutical, Biotech and Medical Device industries.
Overview
29
29
years of professional experience
Work History
Business Partner - Quality, Biolytics & Portfolio
BioNTech
01.2023 - Current
- Responsible for building and executing technology roadmaps for the Quality, Biolytics (Analytical Services) and R&D Portfolio Management departments of the Global Clinical Development Organization.
- Managed cross-functional teams to deliver high-quality projects on time and within budget.
- Prepared and presented reports on status of projects and initiatives.
- Stayed informed on industry developments and market trends to gain competitive advantage.
R&D IT Portfolio Manager
Sunovion Pharmaceuticals
08.2018 - 01.2023
- Developed and Executed the R&D IT Technology Portfolio and 5-year Roadmap that includes GxP, Non-GxP, Regional and Global systems and applications.
- Partnered with R&D Business Units across the global organization to identify and translate business strategy into solutions.
- Program/Project Management execution of GxP and Non-GxP application implementations using Agile and Waterfall methodologies.
Business Systems Manager
Sunovion Pharmaceuticals
06.2017 - 08.2018
- Global IT Project Manager for R&D Systems and Applications (CTMS, QMS, eTMF, LIMS, RIMS, CTR, DMS, Clinical Data Repositories and reporting tools).
- Led successful software migration projects with thorough planning and execution strategies.
- Evaluated emerging technologies to assess potential benefits for the organization's operations and growth objectives.
- Reduced project completion time by effectively managing cross-functional teams and resources.
- Optimized business processes by identifying and implementing strategic system improvements.
Principal Business Analyst
Sunovion Pharmaceuticals
08.2013 - 06.2017
- Project Manager for Domestic and Global System Implementations and upgrades (CIMS, LIMS, GDMS, eCTD, RIMS).
- Authored and Reviewed System Validation Documentation (Protocols and Summary Reports) that adheres to GAMP5 guidelines.
- Coordinated, Managed and Executed Installation Qualification (IQ), Operational Qualification (OQ)and Performance Qualification (PQ) test scripts.
- Delivered detailed project status reports, enabling stakeholders to make informed decisions regarding resource allocation.
Business Systems Consultant
Genzyme, A Sanofi
09.2012 - 07.2013
- Global program management position responsible for providing leadership, governance and direction for Corporate Quality Laboratory eSystems (QMS, LIMS, Metrology, DMS) software application.
- Collaborated with stakeholders to define project scopes and establish realistic timelines for successful completion.
- Mitigated risks in system implementations by conducting thorough risk assessments and establishing contingency plans.
- Provided expert guidance on best practices in IT systems implementation, leading to smoother transitions for clients.
Principal Business Analyst
Genzyme, A Sanofi
06.2010 - 09.2012
- Optimized workflows, leading to increased productivity and efficiency across teams.
- Improved communication between departments by establishing clear lines of responsibility and reporting structures.
- Collaborated with cross-functional teams to drive successful implementation of new software systems.
- Coordinated efforts between IT department and business units during system implementations, ensuring seamless integration into daily operations.
Technical Writer
Johnson & Johnson
12.2009 - 06.2010
- Proved successful working within tight deadlines and a fast-paced environment.
- Managed version control and timely updates of documents through effective project tracking and organization skills.
- Conducted thorough document reviews to identify inaccuracies, inconsistencies, or areas needing clarification.
- Collaborated with cross-functional teams to gather information for accurate and comprehensive documentation.
- Coordinated with subject matter experts to ensure the accuracy of technical content in documentation projects.
Technical Writer
Wyeth Pharmaceuticals
05.2005 - 12.2008
- Managed the creation and revision of SOPs, Reports and Protocols to achieve milestones.
- Identified GMP documentation impacted by the development and transfer of new products.
- Identified resources to contribute to the creation of GMP documentation.
- Managed version control and timely updates of documents through effective project tracking and organization skills.
- Proved successful working within tight deadlines and a fast-paced environment.
ERP Project Manager
Speidel
09.2001 - 04.2004
Manager of Partner Services
ValueClick
03.2000 - 08.2001
Internet Sales Manager
CompUSA
07.1996 - 03.2000
Mutual Fund Accountant
State Street Bank and Trust Company
05.1995 - 07.1996
Education
Bachelor of Science - Finance
University of Massachusetts - Dartmouth
North Dartmouth, MA05.1995
Skills
- Project Management Professional, PMP
- Strategic Road Mapping
- Demand Collection
- Waterfall and Agile Methodologies
- Project Management
- Program Management
- Business Relationship Management
- GxP System Validation
- System Development Lifecycle Management (SDLC)
- Quality Management Systems (QMS)
- Laboratory Information Management Systems (LIMS)
- Clinical Trial Management Systems (CTMS)
- Clinical Data Repositories (CDR)
Timeline
Business Partner - Quality, Biolytics & Portfolio
BioNTech
01.2023 - Current
R&D IT Portfolio Manager
Sunovion Pharmaceuticals
08.2018 - 01.2023
Business Systems Manager
Sunovion Pharmaceuticals
06.2017 - 08.2018
Principal Business Analyst
Sunovion Pharmaceuticals
08.2013 - 06.2017
Business Systems Consultant
Genzyme, A Sanofi
09.2012 - 07.2013
Principal Business Analyst
Genzyme, A Sanofi
06.2010 - 09.2012
Technical Writer
Johnson & Johnson
12.2009 - 06.2010
Technical Writer
Wyeth Pharmaceuticals
05.2005 - 12.2008
ERP Project Manager
Speidel
09.2001 - 04.2004
Manager of Partner Services
ValueClick
03.2000 - 08.2001
Internet Sales Manager
CompUSA
07.1996 - 03.2000
Mutual Fund Accountant
State Street Bank and Trust Company
05.1995 - 07.1996
Bachelor of Science - Finance
University of Massachusetts - Dartmouth
Similar Profiles
Zainab MukhtarZainab Mukhtar
Medical Expert Clinical Trials at BioNTechMedical Expert Clinical Trials at BioNTech
Mahmad-Ismail HousniMahmad-Ismail Housni
Research Associate-Immuno-receptor Therapy (CAR T cells) at BioNTechResearch Associate-Immuno-receptor Therapy (CAR T cells) at BioNTech
Catherine WatkinsCatherine Watkins
Sr. Director, Global Product Quality at BioNTechSr. Director, Global Product Quality at BioNTech