Sam Mowaswes

Experience

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  American Cyanamid

  Jan 1990 - Jan 1996

  Mgr Discovery Systems

  Accountable for all aspects of R&D IT support and systems for the Discovery Group:• Conducted “Discovery Needs Assessment” which resulted in computerizing all aspects of Chemical Registration system utilizing MDL software (i.e. ISIS, MACCS, and REACCS).• Integrated biological screening databases with structural chemical databases to enable effective decision making and progressing of lead compounds for Herbicide, Fungicide, and Insecticide research into full development.• Oversaw development of computerized chemical reagents/samples tracking and electronic requisitioning system which resulted in 2m$ annualized savings and reduction costs associated with environments disposal of excess chemical regents. • Supported large scale File Trials System in the US, EU, Japan, and Australia.• Supported pilot plant and manufacturing processes at our Hannibal Missouri and Gasport UK facilities. • Participated in implementing ISO 9001 standards focusing on consistency in software development.• Managed Scientific Helpdesk and training functions for all Discovery applications. Show less

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  Wyeth

  Jan 1996 - Jan 1999

  Group Leader - Discovery

  • Accountable for all aspects of IT support for Discovery Systems group. Directed the assessment of a Global Document Management system in support of electronic submission to regulatory agencies. • Managed the integration of Discovery Systems and Document Management Systems related to acquisition of Shell Agricultural business in Germany.

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  First Consulting Group

  Jan 1999 - Jan 2001

  Delivery mgr

  • Managed Clinical and Regulatory support center for R.W. Johnson Pharmaceutical Research Institute (RWJPRI). Directed a staff of 11 in the maintenance, administration, and support of Clinical and Regulatory Systems.

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  BMS

  Jan 2001 - Jan 2005

  Associate Dir Global Development Informatics

  • Managed IT capabilities including support of data management, and trial management for Global Development department.• Led Global Development Informatics support and directed Information Systems staff and consultants.• Collaborated with clinical and data management staff to implement Remote Data Capture (RDC) with Oracle Clinical. Established and managed system integration plans and provided oversight of pilot activities.• Developed and implemented software life cycle methodology which improved the overall maintenance and operations for Global Clinical Informatics.• Managed the integration of Clinical Information Systems and staffing during DuPont/Merck Pharmaceuticals acquisitions. Show less

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  Wyeth

  Jun 2005 - May 2006

  Director, Global Scientific Affairs

  Accountable for relationship management and delivery of efficient and timely IM Services for Wyeth Consumer Healthcare Division. Managed Sr. staff (5 directors) and over 38 associates at three locations. Established CoEs for data warehousing, eTrial management, document and records management, submission, labeling, and Helpdesk services.

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  Daiichi Sankyo Pharma

  Jul 2006 - Aug 2015

  Head of Information Management and TMF Operations - Global R&D

  • Acountable for all aspects of Information Management strategy and execution in support of Global Clinical and Regulatory operations• Experience in leading Trial Master File (TMF) Operations for global trials while maintaining a flexible staffing model and global inspection readiness• Business process owner for key R&D processes associated with creating, distributing, registering, archiving, and retrieving TMFs and clinical trials• Established Information Governance Technical Steering Committee with representation from executives for key R&D functions.• Accountable for poject sponsorship, employee development, budget, vendor management, and communicating project progress to stakeholders• Extensive work knowledge of regulatory requirements concerning GxP applications, GAMP5 and 21 CFR Part 11• Defines, in close cooperation with key users, detailed user requirement specifications, manage functional/technical designs and ensures deliverables as described in the Validation Plan are met and signed off as appropriate• Led implementation of key IT systems (i.e. eTMF, EDMS, and eCollaboration portal).• Overall accountability for performance management of personnel including goal setting, performance assessments, and remediation of performance issues. • Negotiated vendor contracts, timeline extensions, and deliverables • Streamlined outsourcing of application maintenance and operational activities to external services providers while maintaining focus on global strategic business initiatives in 4 regions• Oversight of cross functional Standard Operating Procedures (SOPs)/Work Practices (WPs) and guidance documents, while ensuring compliance with GCP/ICH and regulatory guidelines• Maintained compliance ready operations for all clinical, regulatory and Pharmacovigilliance data across 4 research facilities. Participated in 5 MHRA, 3 FDA, 1 PMDA regulatory inspections Show less