Medical Manager

Purpose of the role:what is the purpose, existence of the role?

The MM has a key strategic role requiring therapeutic area expertise and a clear business understanding to identify and address the relevant medical needs of clinical practice and, to successfully support the optimal use of Roche products and treatments.

The MM links Global Medical Affairs, affiliate and cross-functional team objectives to deliver on data generation and dissemination, knowledge exchange and medical education, and to lead Therapeutic Area Expert (TAE) engagement in a scientific manner.

The MM acts as a guardian of high standards of compliance, ethics, and safety, putting patients at the center of his/her actions and show consistent behaviour in line with our Code of Conduct.

Responsibilities of the role:what are the results you can expect from the role?

Responsibility 1: Develop & implement the medical part of the disease area in the customer driven team

• Identify local evidence gaps, manage data generation by evaluating local and global study protocol proposals, manage study planning (including e.g. feasibility and budget) and implementation, develop data dissemination strategy and medical education activities.
• Align the local medical strategy with the customer driven team strategy, Roche Global strategy and global medical plan.

Responsibility 2:Share medical expertise and customer insights in the Customer Driven Teams (and beyond if needed)

• Offer expert opinion aligned with Roche Global medical recommendations on scientific medical information to identify and develop effective peer-to-peer relationships to execute our product strategies in line with the Roche Code of Conduct, while holding high ethical standards, compliance to Roche standard operating procedure (SOP) and local/international regulations.
• Research, collect, present and offer data insights related to the dedicated disease area and product(s).
• Provide medical/scientific support and training for internal staff or vendors.
• Close follow up of training and SOP requirements based on Cornerstone.
• Manage integrity and accuracy of scientific and medical data communicated both internally and externally for promotional and non-promotional purposes and ensure medical clearance of promotional and non-promotional materials.
• Manage publication related activities according to Roche Policy and SOPs
• Develop a customer centricity culture, making sure promotional / medical / scientific communications address Health Care Professional (HCP) needs and optimize patient benefit and safety while keeping a fair balance and compliance with regulations and SOPs.

Responsibility 3: Contribute to the local clinical operations activities and close collaboration with Country Clinical Operations (CCO)

• Design of local medical affairs (LMA) clinical trials, oversight of execution, budgeting and reporting of LMA and global medical affairs (PDMA) clinical trials according to ICH-GCP, Roche Standard Operating procedures (SOPs) and local regulations in close collaboration with the Country Clinical Operations (CCO) team.
• Ensure timely publication and dissemination of the clinical data.
• Close collaboration and communication with CCO, including but not limited to implementing studies, providing input on feasibility, sites and investigators.
• Provide early insights on new products and indications in close collaboration with CCO.
• Inform other concerned Affiliate functions and cross-functional team members on local and global planned studies.
• Implement and follow up (according to SOP and local regulations) of patient programs e.g. Compassionate Use Programs, Medical Need Programs, Patient Support Programs.

Responsibility 4: Have a documented TAE engagement plan and execution to support medical objectives

• Identify TAEs and develop and establish meaningful scientific relationship with TAEs / experts.
• Maintain valid contacts with investigators for key studies.
• Ensure that all activities towards external TAEs / experts are harmonized across the affiliate and documented.
• Share Best Practices across customers to facilitate improved patient outcome.
• Planning, execution and follow-up of relevant scientific advisory boards and expert meetings.
• Gain advice, share insights and create learning opportunities with TAEs / experts who are qualified sources of expertise within the disease area
• Provides relevant Congress information to the Congress Team, approves or rejects selected HCPs and oversees the number of participating Roche employees vs participating HCPs.

Responsibility 5: Give support to Pharmacovigilance, Regulatory, Market Access & Medical Information activities

• Ensure appropriate adverse event reporting according to the Roche safety requirements and close collaboration with Local Safety Unit (LSU).
• Give 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
• Support and collaborate with pharmaco-economic and market access teams, providing relevant efficacy and safety data on dedicated products.
• Manage Medical Information activities in accordance with regional/local model, referencing global standard responses
  
  

Requested profile for the role:describe what kind of profile is needed for the role.

Education level & General experience:

·Medical degree or University degree in biomedical sciences or pharmacy (or comparable)

·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

Technical knowledge:

• Knowledge of relevant therapeutic area
• ICH, GCP and local regulations
• Knowledge of drug discovery & commercialization process
• Fluent English language knowledge, written and verbal
• Fluent Dutch language knowledge, written and verbal
• Fluent French language knowledge, written and verbal

Behavioural Competencies:

• Strategic thinking
• Analytical skills
• Result orientated
• Communication, interpersonal and networking skills
• Partnering skills
• Negotiation skills
• Presentation skills
• Knowledge in data analysis and statistics