· The MM is a key strategic leadership role requiring therapeutic area expertise and clear business understanding to identify and address the relevant medical needs of clinical practice, to successfully support the optimal use of company products.
· He/she links affiliate to Global Medical Affairs objectives to deliver on data generation, knowledge exchange / data communications, and to lead TAE engagement in a scientific manner.
· The MM acts as a guardian for high standards of compliance, ethics, and safety of company products, putting patients at the center of his/her actions.
· Medical expertise and customer insights to the Brand team.
· Development of effective interactions with Clinical Operations (both PDG and PA/GPS), including but not limited to placing studies, provide input on feasibility, sites and investigators selection.
· TAE engagement plan to support medical objectives: identification, development, and establishment of scientific relationship with TAEs
· Support for Regulatory and Medical Information activities for selected products
· Medical and regulatory clearance of promotional and informational materials
Medical Affairs Activities
· Evaluation of incoming requests of research & educational grants
· To review congress participation, HCP selection and logistics as per symphony guidelines.
· To review request letters and ensure processing, archiving and maintenance of documents and log file as per company guidelines.
· To review non-promotional and promotional material according to IFPMA code and company policies.
· To coordinate with commercial for execution of non-promotional activities.
· Design and implementation of non-promotional symposia and selection of recipients of travel sponsorship
Development and management of the medical plan
· Align the global medical plan and strategy, local medical plan, local marketing plan and global medical plan, under supervision of Head of Medical
Medical expertise and customer insights to the brand team
· Offer expert opinion aligned with LCT/IMT/DSC medical recommendations on scientific medical information to identify and develop effective peer-to-peer relationships to execute our product strategies, while holding high ethical standards, compliance to company SOP and local/international regulations
· Manage the integrity and accuracy of scientific and medical data communicated both internally and externally for promotional and non-promotional purposes.
· Manage Medical Information activities in accordance with local model, referencing global standard responses
· Manage publication related activities according to company Policy and SOPs
· Develop a customer centricity culture, making sure promotional/medical/scientific communications address HCP needs and optimize patient benefit and safety while keeping a fair balance and compliance with regulations and SOPs
· Design and implementation of patient support programs
Oversight of local clinical operations activities
· Oversee the phase IV trial program by holding effective relationship with the Clinical Operations team
· TAE engagement plan and execution
· Maintain regular contacts with investigators for key studies
· Identify and develop scientific relationship with external TAEs/ experts who are qualified sources of insight and advice
· Ensure that all activities towards external experts / TAEs are harmonized
· Share Best Practices across customers to facilitate improved patients outcome
· Planning and execution of relevant scientific advisory boards and expert meeting
· Attend / complete all requisite on-line and F2F trainings (Role specific, Safety Responsibility and Compliance) within specified time limit
· Identifies, collects and immediately reports all safety related information on company products to Local Safety Responsible (LSR) as per company requirements and local regulations