Open Jobs at AstraZeneca

What you’ll do?

• Provides strategic and operational regulatory leadership to the development, commercialisation and life cycle management of the assigned product(s) in product teams. Applies knowledge of current local and global Regulatory trends to identify future regulatory requirements and strategies. Influences Regulatory authorities through regular contacts to improve Regulatory outcomes.  Responsible for the management of a skill group such as CMC, Regulatory affairs project management, etc.  Responsible for skill development, performance management, and resource allocation.

Typical Accountabilities

• Provides effective lobbying and influencing on regulatory agencies and trade associations on product and legislative development issues and monitors changes in the regulatory environment in nominated region to support and advise relevant functions.
• Provides strategic regulatory advice support for product developments regional therapy area
• Represents AZRA on relevant external Trade Association committees to ensure AZ RA and/or AZ views on key issues are known
• Ensures adequate risk assessments and mitigation plans are included in the regulatory strategy documents
• Contribute effectively to Global Development programmes, providing expert advice and interpretive inputs on market legislation and requirements that impact on new and existing product registrations
• Ensures effective collaboration across the global, regional and local Regulatory Affairs interface enabling rapid and effective submissions, approvals and other product maintenance activities
• Participates in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project
• Ensures all markets remain in compliance with product licenses maintained and ensuring improvement plans are in place to close compliance gaps. Provide support and advice on training and development to ensure all regulatory personnel in markets have an appropriate knowledge of quality and compliance
• Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration
• If this sounds appealing, please read on to understand the experience and skills we’re looking for…..

Essential Skills and Experience Required 

• Qualifications: B. Pharm Degree Registration with South African Pharmacy Council, MS or PhD in life sciences or related field is required.
• A minimum of 8 years of pharmaceutical regulatory experience is a prerequisite with excellent knowledge and understanding of the current pharmaceutical industry
• Minimum of 5 years in people or team leadership is required
• This role requires a high degree of networking & collaboration both within and outside the organization in Africa.
• To ensure legal compliance with the relevant Health Regulatory Authorities (Country Specific where applicable in Africa), Medicines and Related Substances Control Act 101 of 1965, as amended and South African Pharmacy Act (Act 53 of 1974), and other relevant regulations in Africa.
• Experience with regulatory authorities in sub-Saharan Africa and French Speaking Africa will be advantageous
• Significant experience of regulatory drug development, manufacture, commercialisation or equivalent.
• Knowledge of regulatory procedures and legislation for drug development, product registration, line extension and licence maintenance
• Proven successful leadership and project management experience.
• Fosters an environment that inspires and empowers the team.
• Proficiency in communication is essential for effectively presenting scientific and strategic concepts, whether through spoken or written mediums
• Demonstrated experience in elevating the capabilities of the organization for now and the future.
• Broad background of experience of working in several groups in regulatory affairs or experience at a health authority
• Knowledge of regulatory procedures and legislation for drug development, product registration, line extension and licence maintenance

go to method of application »

What You’ll Do? 

• You will provide medical expertise and execution of the medical plan in the Cardiovascular, Renal and Metabolism Therapeutic Areas. This is a field-based role that provides medical and clinical expertise and builds AZ scientific leadership. The role focuses on the development of professional relationships with Key External Experts (KEEs), building deep scientific understanding of AZ compounds by engaging KEEs in research, medical leadership on faculty and content development for medical programmes, externally sponsored research (ESRs), scientific exchange meetings and advisory board meetings. In addition, you will provide input into Brand Strategy and Life Cycle Management (LCM), as well as implementation of medical activities aligned with brand strategy.

Overview 

• The Medical Science Liaison (MSL) is a medical affairs professional with scientific and therapeutic-area (TA) expertise. They engage in in-depth medical and scientific product or disease area discussions and presentations, in a non-promotional scientific context. These activities, the circumstances in which they are conducted, and the way to perform them in a fully compliant way are described in further detail in the Global MSL Guide. The person will provide medical expertise and execution of the medical plan in the Cardiovascular, Renal and Metabolism Therapeutic Areas. This is a field-based role that provides medical and clinical expertise and builds AZ scientific leadership. The successful individual will be responsible for the execution of the operational plan in addition to delivering on Field Medical KPIs. The role focuses on the development of professional relationships with Key External Experts (KEEs), building deep scientific understanding of AZ compounds by engaging KEEs in research, medical leadership on faculty and content development for medical programmes, externally sponsored research (ESRs), scientific exchange meetings and advisory board meetings. In addition, the MSL will input into Brand Strategy and Life Cycle Management (LCM) and implementation of medical activities aligned with brand strategy. Further accountabilities include providing medical input to the creation, development and agreement of promotional material and ensure all material is in line with internal SOPs, as well as supporting training programs with the medical representatives, focused on clinical trials.           

Typical Accountabilities will include:

Medical and Scientific support for External Stakeholders:

• Scientific Exchange: Support medical/scientific knowledge, education and comprehension of all relevant clinical data.
• Engage Key External Experts (KEEs), Health Care Practitioners (HCPs) and other external stakeholders by proactively providing on-label scientific updates and information on AZ disease areas and marketed products as part of non-promotional scientific exchange
• Respond to unsolicited requests for information about unapproved AZ products or unapproved uses of approved products.  Present such information in an objective, scientifically balanced and substantiated manner
• Provide scientific support in educational events and through appropriate medical sponsorships
• Develop and implement a KEE engagement plan in collaboration with Medical Manager (MM).  Include in the plan details around contact with KEE including the pre call plan with clear objectives for the interaction, key points for discussion, and details on the medical or scientific data to be shared and discussed
• Organizing and leading scientific exchange meetings or regional advisory boards
• Participating as scientific speakers at medical meetings consistent with the Global MSL Standard.
• Stakeholder Engagement: Develop, enhance and maintain external stakeholder engagement
• Proactively identify KEEs with high levels of scientific expertise in local treatment practice to collaborate on activities consistent with the local Field Medical Strategic Plan
• Build AZ relationship with key external stakeholders (e.g. patient advocacy groups, key medical organisations, hospital pharmacy) consistent with Medical Affairs’ objectives. Find opportunities to collaborate with such external stakeholders.
• Monitor database (Veeva) of KEEs and provide recommendations for advisory board members
• Clinical Development: Support the scientific programs that explore unmet medical needs in priority disease areas.
• Identify pre-clinical, clinical and post-marketing study investigators in alignment with Medical Affairs’ objectives.
• Engage in discussion with potential and existing external investigators about Company Externally Sponsored Research (ESR) strategies and setting expectations around the process of submission and review of ESR;
• Work with KEEs, HCPs in scientific and clinical trial activities that help support study recruitment, development and understanding of all studies including ESRs, RWE and company-sponsored studies.
• Medical and Scientific support for Internal Stakeholders:
• Scientific/Subject Matter Expertise:  Act as scientific expert in priority disease area(s) for internal stakeholders.
• Provide internal stakeholders with an understanding of clinical practice trends and actionable (strategic) information or insight that supports the value and appropriate use of AZ products
• Support appropriate AZ staff training on clinical data, trends in clinical practice within TA
• Provide relevant and timely feedback on KEE/HCP interactions using available resources (Veeva Medical CRM tool, Email, Chatter as appropriate)
• Personal Development: Continually demonstrate development of Scientific expertise in disease area(s) of company focus, Business acumen and strategic thinking.
• Maintain medical/scientific expertise in disease state management, AZ products, emerging therapies, and the competitive landscape
• Demonstrate collaborative leadership and management along with advanced strategic thinking within and across field team and TA
• Continually develop ability to communicate in a variety of situations with various stakeholders
• If this sounds appealing, please read on to understand the experience and skills we’re looking for…..

Education, qualifications and experience required:

• Must have a completed Bachelor’s degree in Medicine or Science equivalent qualification (Masters/PHD)
• Minimum of 1-2 years MSL experience in the pharmaceutical industry would be advantageous
• Must have a valid Drivers License
• Current familiarity with healthcare environment including opinion leaders, academia, the medical community, patient needs and related dynamics.
• Demonstrated expertise in synthesizing scientific information and communicating it effectively at peer level with HCPs
• Effective and demonstrated communication skills (both oral and written)
• Excellent interpersonal, project management, leadership and teamwork skills
• Must be able and willing to travel: 60% In-field and 40% office. The territory would be Gauteng and KZN.