Medical Lead

Job Description

The PositionPositionMedical LeadJob FamilyMedicalPosition Reports toHead of Medical AffairsPurpose

• 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.
• 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

Detailed ResponsibilitiesMedical 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 Roche 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 Roche 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 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
• 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

Additional Responsibilities:

• Attend / complete all requisite on-line and F2F trainings (Role specific, Safety Responsibility and Compliance) within specified time limit
• Identifies, collects and immediately reports allsafetyrelated information on Roche products to LocalSafety Responsible (LSR)as per Roche requirements and local regulations

EssentialQualifications

• Bachelor degree in Medicine
• Additional business degree would be an advantage.

Experience and Knowledge

• A minimum of 2 years of experience in medical is mandatory
• A minimum of 2 years of professional experience in the pharmaceutical medical is preferred
• Experience in specialized therapeutic area is preferred
• Experience in KOL relationship management
• Experience in the principles and techniques of data analysis, interpretation, and clinical relevance
• Has experience in preparation and delivery of scientific program preferred
• Familiar with code of conduct and Pharma regulations
• Knowledge of relevant therapeutic area
• Knowledge of the overall drug development process relevant to pharmaceutical/biotechnology organizations
• processes
• Relationships with external TAEs, other thought leaders, and external organizations is strongly preferred
• MS office literate
• Fluency in English written and verbal

Competencies

• Project management skills
• Managing change and conflict resolution
• Leadership skills
• Strategic thinking
• Analytical Skills and experience in data analysis
• Results orientated
• Communication/interpersonal skills
• Influencing and coaching skills
• Presentation skills
• Demonstrable team working ability as it involves internal and external networking across the markets
• Excellent planning and organizational skills to demonstrate leadership and initiative.
• Excellent problem solving ability in addition to strong negotiation skills
• Ability to work in Matrix multicultural organizations and collaborate effectively with commercial counterparts

Key Relationships to reach solutionsInternal

• Commercial Team
• Head of Medical
• Regional HQ
• Clinical Operations Pharmacovigilance Regulatory Affairs Compliance
• MSLs
• Pharmaco-economics

External

• KOLs and HCPs
• External Partners
• Customers, TAEs

Who we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we?ve become one of the world?s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.Roche is an Equal Opportunity Employer.

Keyskills :