This role will generate Medical insights and improve patient access to biosimilar medicines, which is a key focus area for the ZA business.

Major accountabilities:

-Support country medical affairs strategy in line with the global strategy, country insights and market conditions, and secure implementation of planned Medical Affairs activities within the designated therapy area(s).
-Coordinate scientific meeting, symposia, congresses, Continuous Medical Education (CME) and other medical / scientific exchange and engagement activities which could bring additional value to the relevant therapy area; develop strategic engagement plan(s) for country customer-facing medical activities and events, and ensure timely execution of planned medical affairs activities in an efficient and compliant way.
-Ensure medical enquiries are responded to in a high quality, timely manner, and in accordance with applicable standards; establish standard response documents as appropriate, for frequently asked questions.
-Provide medical/scientific input into the development and execution of clinical trial or clinical research related activities, including initiation and oversight of clinical studies / clinical research within the respective therapeutic area. Support country strategy for Non Interventional Studies/Investigator Initiated Trial activities.
-Coordinate review and approval of medical materials and locally developed promotional materials; ensure medical materials provided from global or region for stakeholder engagement and events are tailored to local needs, and reviewed/approved per local/P3 guidelines.
–Ensure medical insights are provided to cross functional groups, including, but not restricted to: Pharmacovigilance, Regulatory affairs, Market Access, QA, Commercial teams, Brand team and others.
-Responsible for risk identification and assessment, mitigation planning as well as implementation and monitoring of appropriate internal controls within the area of responsibilities.

Education:
Advanced degree (e.g. PharmD., MD, PhD) in a relevant scientific discipline is preferred but candidates with an undergraduate degree in a relevant discipline and demonstrated experience will be considered.

Preferred Experience:
• Experience in developing and maintaining expert knowledge for the assigned therapeutic area, and in medical research in general
• A minimum of 2-3 years working in a clinical or pharmaceutical environment
• Solid knowledge of the pharmaceutical environment and the role of Medical Affairs to advance the medical and scientific objectives of a pharmaceutical company.
• Demonstrated expertise in the scientific methods applied to clinical research and current legislative/regulatory controls applicable to this research.
• Ability to comprehensively learn about new subject areas and environments.
• Excellent written and spoken communication and presentation skills, with a demonstrated ability to develop and maintain strong collaborative relationships with external experts, physicians and other healthcare decision makers.

Languages:
Fluent in English, both written and spoken

Competencies:
• Product Knowledge
• Translating scientific or clinical data into high quality medical information
• Competent in delivering medical / scientific presentations
• Project management skills
• Exercises good judgment on regulatory, legal, quality and technical related compliance issues; ensures compliance obligations are met across all areas of responsibility.
• Positive and ‘can-do’ approach; biased towards finding solutions and win/wins;
responsiveness and flexibility. Excellent team playing and communication skills; strong sense of ownership and accountability
• Solid knowledge of the pharmaceutical environment, drug development process, and the role of Medical Affairs
• Clinical and scientific knowledge of relevant therapeutic areas
• Comprehensive understanding of compliance topics
• Leadership, management and planning skills
• Understanding of commercial principles including market access