Intercontinental Medical Planning And Operations Lead

Reporting to the Medical Operations Director, the Intercontinental (Intercon) Operations Lead is the Operational/Program Management Lead for the Area TA}. This role is a key operational partner for the Area TA ensuring processes, governance, communication, and tools are in place to optimize the Area TA's ability to deliver on their responsibilities within the broader One Team model. This role plays a critical role for the Area TA from a program management perspective, allowing the Area TA to be proactive in risk management and providing ample lead time for requests and touch points with the affiliates. This role also assists the Intercon Medical VP and the Intercon Medical Operations Director in achieving the business strategic priorities for the Intercon Area and broader R&D initiatives through proper alignment, planning, and execution.

This role also serves as a key contact for the Region (Latin America, MEAR, or Asia Region) to ensure insights and issues resolution for processes, systems, and capabilities because of their position as a liaison between the affiliate Medical Departments and AbbVie Headquarters.  They are a key point of contact for Affiliates in their region, and act as a change champion for cross-functional initiatives.

Underpinning these responsibilities is the requirement to ensure that regional and affiliate medical teams adhere to applicable company standards, policies and procedures, and operate within, a culture of ethical and compliant behavior. 

RESPONSIBILITIES:

         Serve as primary business partner to TA Head and Leads in driving successful Area operational execution of {TA} medical objectives, with responsibilities as described below.

         Project management and governance of recurring meetings (e.g., Intercon-Affiliate TA Team Meetings, Intercon Team Meetings, Evidence Planning).  Governance to include partnership in meeting preparation and agenda planning, facilitation of meeting logistics and discussions during the meetings, tracking of minutes and action items for distribution.

         Ensuring effective communication between Global, Area and Affiliate teams, coordinating consolidation of information as needed; especially with time-zone differences of TA teams, and challenges in communication.

         Tracking and support of Area TA Medical Initiatives and Global initiatives impacting Area/Affiliates.

         Supporting the successful execution of various business processes such as Financial and Long-Range Planning, Gap Analysis and Evidence Generation Planning, Publication Planning, Insights Gathering from a TA perspective.

         Understand key timelines and Area deliverables for launch readiness aligned to TA and serve as resource for operational aspects to Affiliates; partner with GMA Medical Excellence and Customer Excellence group to help drive key initiatives for the Area and Affiliate Medical Affairs teams such as brand Planning and In Field Team Effectiveness programs. Ensure timely deliverable of launch resources, timely delivery of launch trainings to equip affiliate locally, and support as needed to ensure alignment within One Team model when going into various launch readiness reviews.

         Act as operational resource for new or emerging TAs in Area as structure and resources are being determined and allocated.

         Understanding of unique regulatory requirements within regions and launch challenges.  Partnering with Area TA, Customer Excellence, and other stakeholders to optimize affiliate launches. 

         Ensure processes, governances, communication, and tools in place to optimize Area TA's ways of working within One Team model and our enterprise Asset/Brand Planning framework, while simultaneously having structure to ensure local pull through of new processes, tools, and training cascaded from various aspects of the organization.

         Build relationships with key stakeholders (Global Medical Program Managers, Portfolio Program Managers, Global Evidence Solutions, etc.) in the AbbVie ecosystem to assist the Area TA with alignment, governance, and critical aspect of influencing without having direct authority.

         Maintain operational oversight for key TA initiatives from Global to Area and Affiliates with keen understanding of the overall implementation plan and timelines, feasibility, and workload/resource impact to Affiliates.  Establish strong partnership and collaboration with GMA functions to help shape the scope and strategy of Global initiatives for Area implementation.

Other Area Operational responsibilities may include:

         Single point of contact for global medical operations on core processes and/or systems, acting as SME and bringing the affiliate voice to global teams. Represent affiliate interests for global development of new processes / process improvements, and new system specifications; develop tools to aid affiliates in their daily work; and drive the roll-out of new global initiatives within the region.

         Coordinate on-boarding activities for new joining affiliate medical staff; develop and maintain appropriate on-boarding and training tools; provide access to systems, guidance on use and trouble-shooting support.

         Ensure local research activities are conducted in a scientific, efficient and compliant way, with due regard to applicable policies, processes and procedures and national regulations.  Ensure compliant use of AbbVie tools; provide guidance on timeline and budget planning; ensure scientific deliverables are available to support product development; compile study data for affiliate sponsored and managed studies; maintain and improve AbbVie tools and SOP compliance; provide operational guidance and support; conduct affiliate research capability assessments.

         Develop, execute and update centralized sources of information for Key Stakeholders, and make available through the SharePoint site or use of other appropriate tools.

         Provide guidance to improve/maintain adherence to company standards, policies and procedures among affiliate and regional medical staff.  Provide systems compliance support for staff, and support readiness activities for inspections/audits (PV/GCP) as necessary.

         Regional point of contact for Medical Operations.  Escalating concerns, connecting teams to appropriate partners, and address immediate questions and concerns.  Due to time-zone differences within intercontinental, act of regional POC for Affiliates as part of area support function.

         Harmonize area activities, where relevant, by identifying and promoting best practices within (and across) the TAs and driving adoption and utilization of existing tools and resources available for GMA.

ACCOUNTABILITY & SCOPE: 

           As a senior staff member of the Area Medical Affairs organization, support the development, implementation and measurement of core strategic goals for key R&D/Intercon initiatives and projects within region of responsibility working under the direction of the Intercon Medical Operations Director, and in close cooperation with that position's direct reports.

           Provide fully dedicated program management and operational support to the Area TA Leads and Area TA Head.

           Assist with Planning and managing budget and headcount resources for the region and affiliate medical affairs staff.  May be required to assist in one or more additional regions.

           Provide operations support to the Intercon Medical Affairs function to assist in the provision of effective, efficient and quality services to the affiliate medical departments, Global Medical Affairs headquarters groups, Area Commercial, and International Commercial Operations.  Ensure successful planning, timely completion, tracking and reporting of multiple projects' milestones.

           Onboard regional and senior affiliate medical affairs staff and ensure that all regional and affiliate medical staff are enrolled in and complete assigned training.

           Implement uniform processes for affiliate medical affairs departments that are resource efficient and drive compliance, including resource and performance metrics, clinical capability assessment, personnel databases and organization charts.

           Maintain tools such as SharePoint sites to communicate key information about the Region and Affiliate Medical Affairs with key stakeholders including affiliate medical departments, Global Medical Affairs, other R&D functional groups and commercial operations.

           Ensure adherence to company standards, policies and procedures.

           Manage Projects that include partners external to Intercon Medical Affairs or AbbVie.

INTERNAL / EXTERNAL CONTACTS AND INTERACTIONS:

         Regional Medical Affairs Head / other Areal Medical Affairs staff

         Operations Lead, Medical Affairs and (peers), GMA Medical Operations...

         Area TA

         Affiliate Medical Managers, Medical Directors and General Managers

         Affiliate TA staff and Operations teams

         Area personnel:  including Commercial / Regulatory Affairs / OEC / finance teams

         Headquarters personnel, including Clinical Operations staff, Medical Program Managers, Evidence Solutions, etc.

         University/Bachelor's degree or higher, with a strong background in health sciences.

         Experience in a senior role in Affiliate Medical Department, Regional Medical Affairs, or working with Affiliate Medical Departments is desirable.  Hands-on experience managing and leading groups of processionals.

         7 or more years in team and drug development or project management related experience.

         Strong project management/operations skill set, drive, and business experience (PMP certification or Six Sigma Certification is a plus).

         Advanced knowledge of standard business procedures including project management, finance and budgeting.  Excellent cross-functional negotiating skills. 

         Demonstrated leadership skills with broad business orientation.  Ability to command the respect and support of the AbbVie International medical and marketing communities.  Experience in managing "virtual" teams (people in remote locations).

         Excellent communication, networking, tact and diplomacy, and people skills.  Experience in conflict- and problem-solving capabilities.

         Fluency in English and an appreciation of the difficulties and ambiguities in English language usage in the region.  Fluency in a regional language is a definite asset.

         Sensitivity to cultural differences and an awareness of differences in medical and clinical practice in the region.

         Rapidly adaptable to a changing environment and willingness to assess and implement new ideas and opportunities.

         Self-starter with vision and initiative and the ability to work unsupervised towards the achievement of challenging goals.

         Sound judgment, strong Planning and organizational skills, and the ability to get things done.

         Detailed knowledge and experience / expertise in AbbVie systems and processes.

         Excellent communication, networking, tact and diplomacy, and people skills, and ability to take into account cultural differences.

         Proactive and identifies potential issues before they occur

         Operates well in the grey zone when all facts are not necessary currently available, and being able to make a decision with sound rationalization behind it