Global Medical Affairs Manager, AIR - Marketed Products

Purpose

We are looking for a motivated colleague for a permanent potition in our exciting fast changing and rich of opportunities Deparment. The GMA Manager is responsible for leading from GMA standpoint the clinical-commercial optimization of product development and life cycle management strategies and plans for marketed (go to market) programs within AIR Respiratory area, focused on respiratory diseases. He/she will lead the Global Medical Affairs Initiatives and partner closely with R&D, GVA, Marketing, Patient Advocacy functions and Regional Medical/product leaders to develop integrated global medical affairs perspectives, strategies, and plans particularly related to critically relevant markets and geographies. The GMA Manager can be an ad hoc member of the Core Team and part of the Global Commercial Teams and will be responsible for the development of the global medical affairs plan reflecting prioritized global needs included in the overall Compound Development Plan and Global Strategy.

The GMA Manager will be accountable for the global publication plans, global opinion leader relations, global medical education (including symposia, speaker training), and global advisory boards for marketed, potential late phase products or marketed new opportunities. He/she will be also involved in cross-linked projects such as educational programs and events. The GMA Manager will also be responsible for facilitating and ensuring a consistent approach to Medical Affairs programs/activities globally and will support the GMA operational excellence processes particularly the medical insights management and innovation activities (for example Augmented Reality)Additionally, the GMA Manager will provide scientific leadership for GMA-led data generation activities to support access to the market for the programs in scope with particular focus in assigned critically relevant markets.

Main Responsibilities

• Develop global medical affairs strategy and plans based on prioritized global and local needs, working with the R&D and Core team to ensure integration with the overall global compound strategy
• Synchronize input and output of the Med Affairs plan with the strategic and business plan calendars
• Responsible for medical activities including product/Therapeutic Area global advisory boards, medical symposia and congress activities, and close monitoring of local activities in these areas.
• Collaborate closely with the local medical affairs representatives to develop integrated global medical affairs strategies and plans and maintain open, two-way communication to ensure local medical affairs is up to date on all plans, progresses and decisions.
• Act as point of reference for the collection, analysis and strategy implementation of the medical insights in collaboration with the Medical Excellence Team.
• Responsible for the development and execution of the global publication plan as well as review and approval of publications for specified compounds/areas in scope. Manage the Review process (review of all medical affairs sponsored clinical trials and Investigator Initiated Sponsored studies) for applicable products/areas.
• Provide medical leadership for GMA-led data generation activities to support access to the market for marketed products in the assigned geographies, including protocol development and other medical activities, medical monitoring of studies, and data analysis. Work closely with global clinical operations to coordinate affiliates medical activities.
• Develop and maintain KOLs and Scientific/Clinical Societies networks and relationships. Perform KOLs mapping receiving also the input of the Affiliates from the geographies in the scope.
• Responsible for Identifying, planning and executing scientific, educational and communication initiatives, in alignment with the line manager and cross-functional team, supervising, when applicable, contents together with KOLs or Advisory Boards. The needs of Global and local HCPs’ community should be matched to support AIR Franchise strategy.
• Support congresses and professional representation at international medical meeting and conferences.
• Responsible to ensure all global activities follow Chiesi Compliance principles, e.g. Health Care Compliance, etc.
• Perform compliance check and promo material approvals for the assigned project(s). 

Experience Required

• A minimum of 5 years of combined relevant experience in a medical/clinical environment and/or scientific function in the pharmaceutical industry is required.
• At least 3 years in  Medical Affairs with a role equivalent to Medical Advisor is  required.
• Clinical and/or pharmaceutical experience in respiratory diseases is considered a plus as well as the knowledge of inhalers and lung drugs’ delivery.
• Track record experience leading a study (observational, non-interventional) to support evidence generation and market access needs and managing or leading role in educational contents and projects.
• A demonstrated track record of effectively working in a highly matrixed, cross-functional environment is required, as well as a demonstrated track record of success within Medical Affairs and/or clinical R&D, and/or Global Medical Affairs

Education

Medical (preferred) or PhD degree with 3y Pharma experience OR Life Science Degree with 5y Pharma experience

Soft Skills

• Proven ability to partner and foster collaboation with stakeholders cross culturally/regionally 
• Strategic thinking
• Analytical skills
• Adaptability and flexibility
• Communication skills 
• Goal orientation

Technical Skills

• In-depth knowledge of study methodology, study data reviews, and analysis.
• Strong experience developing and managing strategic relationships with medical experts/opinion leaders and proven ability to act as a medical spokesperson for external audiences 
• Strong scientific acumen and soft skills for navigating internal and external complex working environments
• Highly innovative with the ability to drive a complex and changing environment and effectively manage and resolve issues within the TA.

Languages

Fluent English

Location

The role can be based in one of our affiliates in Europe