Mindy Mackenzie Email & Phone Number

Fitchburg, Ma, Us

Cambridge, Massachusetts, United States

Responsible for the day-to-day support of Field Medical activities in collaboration with a dynamic cross-functional team. Activities include independent management of the operational activities (i.e., CDAs, contracts, budgets, invoice management, etc.). Independent management of advisory board logistics. Management of functional budgets and execution timelines. Coordination of team meetings and logistics. Project management, project planning, and goal tracking. Management and administration of SharePoint, Veeva CRM, Veeva Vault Smartsheet and other document repositories (i.e., content maintenance and review). Management of medical literature review tool (Veeva Vault) and related functionalities. (i.e Manage progress of documents throughout workflow, onboard new users, (internal & external) train on electronic workflow system and the coordination of team meetings and logistics. Assist with monthly and quarterly metric reports and analytics dashboards. Collaboration on SOP development and promotion of standardized business tools. Support the implementation of external software solutions/data platforms to support business needs.

Cambridge, Massachusetts, United States

Responsible for ensuring the timely and compliant implementation and execution of key projects and associated deliverables. Routinely interface with the Data Generation lead to support all aspects of the IIR program as well as will serve on launch excellence cross-functional teams to support strategic launch goals and to ensure workstreams are accountable for progress to goals via the delivery of bi-weekly launch excellence dashboards. Also responsible for developing monthly, quarterly, and annual departmental metrics tracking and dashboards inclusive of high-level and granular Gantt charts using Microsoft Project and OnePager as PM tools.

Cambridge, Massachusetts, United States

Provide Program Management support relative to Life Cycle Management including overall processes, timelines, budget and coordination. Partner with key functional key stakeholders to capture all operational details of ISS, RWE, study data milestones, and budget specific to all studies defined in the Medical plan. CSS - approval coordination and central source in Medical for CSO communications and partnerships. Optimize communication and decision-making by ensuring cross-functional representation at relevant team meetings as well as various Medical Affairs’ programs. Build and maintain strong and collaborative partnerships with internal and external parties. Serve as an advocate for the overall collaboration with our alliance partners

Cambridge, Ma

Responsible for the direct management of 7 ISS Project Managers in Global Medical Affairs Operations, supporting the Rare Disease business unit. Additionally project manage over 90 IST initiatives in the Global Rare Disease space. Responsibilities include budgeting, management of incoming proposals, guidance of proposals through the scientific review process, contracting, initiation of POs, and payment of milestones. Provide follow up and updating from inception to completion. Ensure timely delivery of SAE safety notifications and ensure problem resolution. Other project support provided as needed.

Cambridge, Ma

Offer support to Investigator Sponsored Study project coordinators managing Rare Diseases and MS. Provide system administration for ISS management tool "Vision Tracker", and Compliance e-training tool "Le@rn". Manage incoming grant requests directed at MS Patient Advocacy.Act as departmental contract coordinator in corporate e-procurement tool shepherding PO requests from inception through PO creation. Continually update internal departmental web pages, and assist with monthly reporting, along with ad hoc departmental requests.

Support custom Kofax electronic image application (Markview) as system administrator and internal customer support. Also provide support for the company Grants Program administering the MicroEdge application and supporting both internal and external customers. Provide data analysis on both systems and respond to customer help desk calls. Additionally I support the corporate purchase card program as the PCard administrator through Visa online banking and the use of Concur expense systems.

Bachelor Of Science, Business Administration

Associate Of Science, Early Childhood Development