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 Roche 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 Roche products, putting patients at the center of his/her actions.
The Medical Manager (MM)
Is a local role
Is a member of the affiliate MAs department
Works closely together with MKT team in a specific Therapeutic Area/Product
Reports to
Senior Medical Manager or Affiliate Medical Director
Direct Reports: MSLs where applicable
Responsible for
Development of the local Medical Plan
Medical expertise and customer insights to the Brand team
Design, oversight of execution, and report of clinical trials according to ICH-GCP, Roche SOPs and local regulations
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 PharmacoVigilance activities, including assurance of appropriate adverse event reporting in coordination with LSR
Support for Regulatory and Medical Information activities for selected products
Medical and regulatory clearance of promotional and informational materials
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
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 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 responses
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
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
Design and implementation of patient support programs
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
Qualifications
Medical Degree.
Experience
Professional experience within the pharmaceutical industry desirable but not mandatory
Knowledge of the overall drug development process relevant to pharmaceutical/biotechnology organizations
Experience in development and implementation of clinical trials
Experience in the principles and techniques of data analysis, interpretation, and clinical relevance
Experience of writing clinical publications and delivery of scientific presentations
Relationships with external TAEs, other thought leaders, and external organizations is strongly preferred
Knowledge
Knowledge of relevant therapeutic area
ICH, GCP and local regulations
Appreciates the diversity of working with multifunction teams
Knowledge of drug discovery & commercialization processes.
MS office literate
Fluent English language knowledge, written and verbal
Competencies
Strategic thinking
Leadership skills
Analytical Skills
Results orientation
Communication, interpersonal and networking skills
Negotiation skills
Presentation skills
Knowledge in data analysis and statistics
Who we are
En Roche, nuestro éxito se basa en la innovación, la curiosidad y la diversidad, multiplicado por 94,000 profesionales en 100 países. Trabajando juntos, nos hemos convertido en uno de los grupos líderes de salud enfocados en la investigación.
Roche es una empresa que ofrece igualdad de oportunidades
