Experience

Organon Canada

• Canada
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• PSP Program Manager

  • May 2021 - Present

  Patient Support Program (PSP) Program Owner and vendor manager ensuring all aspects of the program are functioning as planned including the management of vendors with their procedures, performance, and operations for alignment of timelines. Identfying Canadian patient & healthcare professionals’ support needs and deliver solutions in collaboration with cross functional colleagues. Analyzing program metrics, access accuracy of data, mitigating risks and identify opportunities for improvement. Managing the communication channel between the internal and external parties by ensuring compliance with program requirements and delivery of optimal results. Participating in new product launches and products, forecasting and planning associated with program operations.



Merck

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Associate Operations Manager

  • Jan 2020 - Jun 2021

  Support Biosimilar Patient Support Program (PSP) by ensuring that all aspects of the program are functioning as planned including the management of vendors with their procedures, performance, and operations for alignment of timelines. Analyzing program metrics, access accuracy of data and identify opportunities for improvement. Managing the communication channel between the internal and external parties by ensuring compliance with program requirements and delivery of optimal results. Support Biosimilar Patient Support Program (PSP) by ensuring that all aspects of the program are functioning as planned including the management of vendors with their procedures, performance, and operations for alignment of timelines. Analyzing program metrics, access accuracy of data and identify opportunities for improvement. Managing the communication channel between the internal and external parties by ensuring compliance with program requirements and delivery of optimal results.



Innomar Strategies

• Canada
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Manager, Specialty Services

  • Jul 2017 - Jan 2019

  Senior project management of patient support programs, including strategic alignment, tactical, budgetary and account management planning. Implementation of specific projects within the Specialty Services department. Providing strategic direction to program managers to further enhance and optimize processes for all client account satisfaction and team management.

• Program Manager, RPS, Specialty Services

  • Apr 2015 - Jul 2017

  Project management of a patient assistance program; including the supervision, ongoing development and performance of a team, project reporting and statistics, ongoing client project communications, design and development of new projects including development of protocols, resource allocation, lead in process improvement initiatives and database upgrades, assist with quality assurance and quality improvement initiatives.



Algorithme Pharma | An Altasciences Company

• Canada
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Team Leader, Documentations Specialist

  • Jul 2014 - Apr 2015

  Manage the CRF Log Designers team to ensure the documentation is in compliance with protocols, SOPs, GCPs and regulatory guidelines for all sites Manage the team members developmental, training performance goals Manage and perform Clinical documentation creation (Clinical Report Forms, Non-CRF, study working tools, SOPs) for every clinical study Create, implement and manage process efficiencies with regards to data template creation, timelines, management expectations and quality metrics; Work actively with Study Managers and Data Management to ensure the on-time delivery of all clinical documentation Work with Clients to ensure protocol documentation requirements are being met Coordinate and implement Quality Systems into the document creation process. Collaborate with IT for system upgrades, including in-house tools Oversee the writing and review of Clinical SOPs Review deviation reports for compliance and to prepare trending reports for SOP deviations, additional comments, and QA reports Promote Quality initiatives to improve documentation quality in the Clinic Participate in process improvement initiatives (Kaizen) and use metrics to identify areas of further improvement



FX Innovation

• Montreal, Quebec

• Consultant for Standard Life - Business Change and Release Manager

  • Jan 2012 - Jun 2013

  Determine and lead change management activities for the three lines of business using PROSCI methodology. Monitor and control the quality of deliverables according to the Agile methodology and institutes action plans to ensure change management Manage release approvals of Continuous Improvement initiatives Create and streamline release and change management process activities and roadmaps Lead and facilitate Operational Committee meetings with internal clients and keep all impacted stakeholders informed throughout the projects’ timelines. Work actively with the project management Office and IT departments to ensure rigorous application of change management process from the ePMO Liaise with cross-functional departments to ensure that change initiatives are being met. Publish a monthly internal communications detailing change initiatives.



Techno 5

• Consultant for Orange Business Services - Change Management and QMS Documentation Manager

  • Mar 2010 - Nov 2011

  Perform Change Request validation and definition with global Work StreamsImplement and streamline process improvement activitiesManage approvals of Change Requests and Process Design ImprovementsRefine and ensure adherence to Change Management defined policies and processesManage and facilitate Change Advisory Board meetings, with internal and external clientsProduce Weekly and Monthly Change Management Reports and StatisticsProvide Change Management support and assistance Train colleagues on policies and procedures Ensure appropriate inputs are in line with stakeholder’s respective roles and responsibilitiesWork actively with the Project Management Office to ensure rigorous application of change management process from the PMOEnsure Quality Management System compliance to corporate & project documentation standards and practices. Liaise with cross-functional departments to ensure compliance and adherence to applicable regulatory requirements is respected. Prepare internal and external audit activities. Manage the issuance and distribution of documentation updates. Administrator for SharePoint DHF site.

• Consultant for Orange Business Services - QMS Documentation Manager

  • Mar 2010 - Sep 2010

  Ensure Quality Management System compliance to corporate & project documentation standards and practices. Liaise with cross-functional departments to ensure compliance and adherence to applicable regulatory requirements is respected. Prepare internal and external audit activities. Assist with the formalization of documents, as required by the Quality Management System and business needs.Manage the issuance and distribution of documentation updates. Administrative duties for SharePoint DHF site. Maintain Training records, and personnel qualifications.



MDS Pharma Services (formally Phoenix International Life Sciences)

• Ville St-Laurent, Quebec

• Manager, Information Systems

  • Jun 1989 - Jul 2009

  Manage internal and external personnel involved in the development of the database and software. Manage and maintain various software applications and departmental performance statistics. Hold a leadership role in strengthening MDS PS’ quality training regarding software and hardware implementation and utilization. Manage transition planning and data process conversion. Manage system application inquires. Identify and make decisions based on risk assessment. Report any problems, pertaining to the database systems. Offer technical support and implementation assistance. Ensure that all new and existing equipment is in validated state and is in compliance with appropriate regulations and industry standards. Participate as a site clinical representative for: a global validation team, client audits, external organization audits, several task forces for quality and process improvement using lean six sigma processes.



Phoenix International Life Sciences

• CRC Systems Development Project Manager

  • 1998 - 2000

  Manage in development of internal and external software and personnel. Manage informational training and focus groups pertaining to utilization of software/databases for the department. Assist internal system inquiries regarding database utilization. Identify and report any problems which arise, pertaining to the database systems; offer solutions, technical support and implementation assistance.

• Recruiting DataBase Supervisor

  • 1995 - 1998

  Supervise system development for the creation of a new recruiting and screening data base. Meet the technical needs of the department. Make any adjustments and additions to the database as the need arises, coordinate and maintain departmental statistics, reports, and advertising control.