John Polhemus Email & Phone Number

North Chicago, Illinois, Us

The US Medical Affairs Medical Operations (USMO) team focuses on driving performance through learning, technology, and the practice of innovation. The Director USMO Program Management serves as both a primary point of contact and strategic partner for TA leadership. The scope of this role is US, supporting multiple TAs at a programmatic level. Key Responsibilities Include: * Ensure that Medical Affairs Team (MAT) operations are efficient and effective across TAs and functioning at a high level, including member engagement, performance, and accountability.* Cross-functionally integrate and manage resources. This includes budget and headcount Long Range Planning (LRP) management, product, pipeline, and product launch planning and management, and Medical Review planning and management. In cases of limited resources, will partnered with TAs to prioritize across programs where necessary.* Collect and communicate performance measures for MAT operation across TAs. Monitor performance measures and takes appropriate actions when necessary. These measures include, but are not limited to, headcount, schedules, and budgets across multiple US and Global Medical Affairs functions.* Assess program issues and develop solutions to ensure overall program productivity, quality, and timelines are met within budget, involving other functional areas where appropriate. Identify risks and communicate as needed. Actively seek solutions and takes calculated risks where appropriate. * Work to develop and improve the tools, templates, and processes across a collection of TAs. Work to navigate and anticipate upcoming "planning" processes and deliverables.* Coordination of the LRP process and current financial year activities focusing on collection and reporting of tactical execution, metrics, and financial status/LBE information and maintaining adherence to budget/headcount at a program level. * Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

North Chicago, Illinois, Us

Group Manager of the Regulatory, Quality, and Safety Information Services (RQSIS) Group for Regulatory, Quality, and Safety (RQS) Operations. Accountable for managing the RQS Data Governance Office, and driving the data standards and analysis strategy across RQS. Provide direction to the RQS Information Services team and ensure adherence of program timelines and compliance of global processes. Lead multiple data/information compliance and process-improvement initiatives. The RQSIS Group is comprised of 4 functions; Data Governance Office; RQS Systems data standards development and management; data remediation and harmonization; data health monitoring; and cross system/sub-function reporting to support business data integrity; and answer RQS business questions and ensure data quality and improve productivity. The Group also plays a key role in the development and enhancement of RQS Systems to ensure compliance with Health Authority mandates and new Health Authority initiatives such as Extended EudraVigilance Medicinal Product Dictionary (XEVMPD), Identification of Medicinal Products (IDMP), International Organization for Standardization (ISO), and Structured Product Labeling (SPL).Business System Owner and Program lead for AbbVie’s Regulatory Product Master solution to address the EEA’s IDMP Health Authority mandate. The Regulatory Product Master solution collects structured and unstructured metadata from Labeling, Registration Management, Document Management, Clinical, and Supply Chain systems to populate the product master repository. The data in product master repository that will be use address the EEA’s and other pending Heath Authority IDMP Mandate over the next 5 years and provide an aggregated view of product data in all four phases of product development to the distribution of the marketed product.

North Chicago, Illinois, Us

Sr. Solution Manager for the Regulatory Affairs Business Planning sub-function. Responsible for ensuring alignment of projects and plans with long range business strategies; ensure the delivery of projects that are on time, on budget, and address the targeted business needs; ensure the solutions delivered to the business are effectively supported to derive the most value from the investment; advocate for the business to ensure regulatory compliance; increase efficiencies; and ensure efforts of people and processes are the primary drivers of change. Areas of focus:• Regulatory Affairs Global Labeling department: Implemented multiyear strategy to globally align Regulatory Systems and business processes for the United States and European Union Regulatory Operations, and Abbvie Affiliates. • Regulatory Affairs Advertising and Promotional Material department: Developed a sort term and long term strategy to allow RA PPG to meet the Office of Prescription Drug Promotion (OPDP) requirements of electronically submitting Advertising and Promotional material to the FDA. • Established the Data Quality Manage (DQM) Group in Regulatory Affairs. The group is responsible for developing and implementing business and system data standards and the remediation and harmonization of all data elements within Regulatory Affairs systems. The DQM group is also responsible for monitoring the health of the data across Regulatory Affairs systems and other functional system used by Regulatory Affairs professional.Business Planning Manager. Responsible for managing a team Solution Managers, Initiative Managers and contractors that supported key Regulatory Affairs business processes and systems and Capital Projects. Member of the Business Planning Leadership Team and provide Subject Mater Expertise for all Regulatory Affairs sub-functions.

Abbott Park, Illinois, Us

Capability Manager for the Regulatory Affairs Pharmaceutical Products Group Business Planning. Primary function: Responsible for ensuring alignment of projects and plans with long range business strategies; ensure the delivery of projects that are on time, on budget, and address the targeted business needs; ensure the capabilities delivered to the business are effectively supported to derive the most value from the investment; and advocate for the business to ensure regulatory compliance, and increase efficiencies and efforts of people and processes are the primary drivers of change.Areas of focus:Global Labeling supporting the Regulatory Affairs Global Labeling Departments. Implemented multi year strategy to globally align Regulatory Systems and Business Processes for the United States and European Union Regulatory Operations and Abbott Affiliates. Ad/Promo supporting Regulatory Affairs Advertising and Promotional Material Departments. Currently developing a sort term and long term strategy to allow RA PPG to meet the Office of Prescription Drug Promotion (OPDP) requirements of electronically submitting Advertising and Promotional material to the FDA. Additional Responsibilities:Business Planning Manager. Responsible for managing a team 2 Capability Managers, 2 Initiative Managers, and contractors that support key PPG business processes and systems and support the RA PPG Initiative Management Office Capital Projects. Member of the Business Planning Leadership Team and provide Subject Mater Expertise for all RA PPG Capabilities.

Abbott Park, Illinois, Us

Sr. Business Technology Consultant for Global Product R&D Division, Global System Delivery. Responsibilities: Support of the various departments, functional areas and Global Project Teams within GPRD so that they may develop an understanding on how technology may benefit their department; help them develop short-term and long-term technology strategies to meet their business goals and needs; and kept them abreast of how Abbott and the Pharmaceutical industry as a whole are using technology to meet business goals. In addition, facilitated the development of project approach, definition, and initial planning; assisted in risk mitigation and issue resolution; and monitored project execution for delivery of business value.

Us

Systems Manager and Sr. Project Manager for TAPs MIS R&D Department. Responsible for managing the activities and people associated with TAP projects and the success of those projects. Work with users to identify and define their business needs; develop conceptual level requirements in the analysis phase; support the development and production environment proactively through tracking management activities; managed the MIS R&D System 2002 Budget; created the MIS R&D 2003 Budget; and responsible for the ongoing systems and business needs of the client/user community.

Eden Prairie, Mn, Us

Account Executive for Encore Development Inc. in their Chicago Division. Primary responsibilities were developing new business opportunities and managing existing clients.

Stockholm, Se

Metro Information Services, Inc. was a high-end staff augmentation and Project Management company that work at all layers of the IT architecture for a very divers client base in 47 different location through-out the US and Puerto Rico. Metro went Public in 1997 and was purchased by Keene around 2000.

Tidewater Consultants, Inc (TCI) was a Software development company that designed, installed, and supported Shipboard Systems, Shore Based Systems, and Management, Budget, and Resource Systems for the US Navy. TCI was purchased my Manclass in the 90’s.

Mis And Management, Bba

Business

General Studies

Regular/General High School/Secondary Diploma Program