Medical Manager (MM) – Sudanes National -Dal Group

Vacancy Details

Job Title:	Medical Manager (MM) – Sudanes National
Date Posted:	25/11/2019
Closing Date:	09/12/2019
Company:	DAL Medical Services Co. Ltd.
Job Classification:	senior-level (7+ years)
Job Category:	General Management
Location:	DAL Medical

Position summary:

• The MM is a strategic and tactical, non-promotional role requiring therapeutic area knowledge and clear business understanding to plan and implement projects that 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 Therapeutic Area Expert (TAE) engagement in a scientific manner.
• The CMM acts as a guardian for high standards of compliance, ethics, and safety of Roche products, putting patients at the center of his/her actions.

Main Duties & Responsibilities:

• Responsibilities: 
  • Development of the local Medical Plan
  • Medical knowledge and customer insights to the Brand Team.
  • Design, oversight, execution, and reporting of clinical trials according to ICH-GCP, Roche SOPs and local regulations
  • Development of effective interactions with Clinical Operations, 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 Local Safety Responsible (LSR)
  • Support for Regulatory, Market Access and Medical Information activities for selected products
  • Review of promotional and other external communication materials.
• Key Activities:
  • Development and management of the Medical Plan:
    
    • Medical gap analysis and development and alignment of the
      
    • local Medical Plan with the local Brand Plan, LCT/IMT/DST strategy and global medical plan, under supervision of GMM/AMD
      
    • Execution and continuous review and update of the local Medical Plan.
      
  • Medical knowledge and customer insights to the Brand Team:
    
    • Offer expert opinion aligned with LCT/IMT/DST medical recommendations on scientific/medical information to identify and develop effective TAE relationships to execute Roche product strategies, while holding high ethical standards, compliance to SOPs and local/international regulations
      
    • Research, collate, present and offer data insights related to the dedicated therapeutic 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.
    • Contribute to Medical Information activities in accordance with regional/local model, referencing global standard responses.
      Manage publication related activities according to Roche policies and SOPs
      Develop a customer centricity culture, making sure promotional/medical/scientific communications address HCP needs and optimise patient benefit and safety while keeping a fair balance and compliance with Medicines Australia and other regulations and SOPs.
      
  • Contribution to local Clinical Operations activities:
    • Oversee the phase IIIb/IV trial program by holding effective relationship with the Clinical Operations team and external investigators or sponsors.
    • Provide early insights on new products and indications in close collaboration with the Clinical Operations group
    • Inform other Affiliate functions on Global planned studies.
  • TAE engagement plan and execution:
    • Maintain regular contacts with investigators for key studies
      Identify and develop scientific relationship with external TAEs who are sources of insight and advice and plan and execute relevant scientific advisory boards and expert meetings.
      
    • Ensure that activities towards external experts/TAEs are coordinated across the affiliate.
      
    • Identify and work with external experts on medical education activities to facilitate improved patient outcomes.
  • Others:
    
    • Inform LSR 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 Market Access/ providing relevant efficacy and safety data on dedicated products
      
    • Act as medical expert for requests from external organisations, e.g. media (via Corporate Affairs department).

Minimum Qualification & Experience:

Qualification:

• Science degree or equivalent.
• Additional business or clinical qualification e.g. MBA, HCP, or nursing desirable.
• Relevant therapeutic area experience.

Experience:

• Overall experience level sufficient to execute the majority of Medical Manager tasks independently under the oversight of the GMM/AMD.
• Professional experience within the pharmaceutical industry desirable but not mandatory.
• 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 organisations is strongly preferred.

Required Skills & Knowledge:

• Knowledge
  • Expert Knowledge of relevant therapeutic area
  • ICH, GCP, GPP and Medicines Australia Code of Conduct
  • Knowledge of the overall drug discovery, development, and commercialisation process relevant to pharmaceutical/biotechnology organizations.
  • Knowledge in data analysis and statistics.
  • 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.
  •  Working with diverse, cross-functional teams.

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