Primary Responsibilities and Accountabilities
1. Development and management of the medical plan
Identify local data gaps, local studies protocol design, study planning (including budget), input to site selection and feasibility assessment, data dissemination strategy
Align the local medical plan with the local marketing, CT / IMT / DST strategy and global medical plan, under supervision of Medical Director
Congress overview and guidelines development
2. Medical expertise and customer insights to the brand team
Offer expert opinion aligned with LCT / IMT / DSC medical recommendations on scientific medical information to identfy and develop effective peer-to-peer relationships to execute our product strategies, while holding high ethical standards, compliance to Roche SOP and local / international regulations
Research, collate, present and offer data insights related to the dedicated disease area and product(s)
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 regional / local model, referencing global standard respones
Manage publication related activities according to Roche 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
3. Contribution to local clinical operations activities
Oversee the phase III-B / IV trial program by holding effective relationship with the Clinical Operations team
Provide early insights on new products and indications in close collaboration with the PDG group
Inform other Affiliate functions on Global planned studies
4. 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 across the affiliate
Share Best Practices across customers to facilitate improved patients outcome
Planning and execution of relevant scientific advisory boards and expert meetings
5. Others (depending on the size & structure of the Affiliate)
Inform Local Safety Responsible person of safety issues according to Roche safety requirements; scientific support and follow-up on product safety issues
Support regulatory activities, including preparation of relevant data for new products / indications’ application and label updates
Provide medical / scientific support and training for internal staff or vendors
Support and collaborative work with pharmaco-economic and access teams, providing relevant efficacy and safety data on dedicated products Act as medical expert for requests from external organizations, e.
g.. media (via PR department)
Design and implementation of congresses booth and non promotional symposia and selection of recipients of travel sponsorship
Evaluation of incoming requests of research & educational grants
6. Budget for phase IV trials and Medical activities
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