Country Head Medical Affairs
6 months ago
**Summary**:
The Country Medical Affairs Head is the lead country medical representative, responsible for adopting and executing the near
- and long-term medical strategy coming from Global/International, forging bold strategic partnership with the healthcare communities and governmental entities. Manage and develop the overall performance of the medical unit in country. Drive best-in-class launch preparedness and launch execution (incl. ensuring precision medicine availability at launch and overcoming local data gaps for HA Submission - when applicable) As a core member of the South African IM Leadership Team this person is accountable for the creation of the functional medical strategy for the country and ensures its execution, by leading all clinical and medical aspects of in-country activities and all associated resourcing and performance aspects.
**About the Role**:
**Major accountabilities**:
**Strategy and Strategic **advice**:
- Raises country medical and clinical interests into global and regional strategy and prelaunch planning, starting at DDP by providing timely and strategic feedback to GPTs. This shapes the development program earlier and ensures IDPs include integrated (Integrated Evidence Plans [IEPs]), diverse data available at launch to support own local reimbursement and clinical implementation.
- In line with the evolving healthcare ecosystem, proactively and strategically builds and strengthens partnerships beyond the traditional healthcare professionals and organizations. Identifies opportunities for joint value creation deploying new engagement models of broader reach.
- Oversees that all local studies are developed and timely executed based on country evidence gaps. Accountable to ensure adherence to all governance, compliance, quality, and safety measures in accordance with local standards in implementation. Ensures effective communication plans in place for external stakeholder education and advocacy.
- Ensures Implementation Science plans in place early and holistically to systematically shape health policy and practice guidelines converging clinical innovations and treatments into better standards of care via better disease management. Depth of insight and understanding of local Healthcare ecosystem and contextual system challenges to ensure early reimbursement and patient adherence.
- Establishes a clinical excellence and treat to target mindset across the healthcare system through medical education activities including preceptorships, clinical excellence collaborations (e.g. heart failure or breast cancer clinics) and continuous medical education-style events.
- Role models ethical standards and contribute proactively to a credible image for Novartis in the country. Represent Novartis at key external governmental, scientific, clinical and medical events to educate, advocate and support innovation and evidence-based research.
**Stakeholder **Engagement**:
- Engages with key patient associations, academic societies, patients, payers and reimbursement bodies as well as the relevant healthcare systems, to harness opportunities and share ownership in transforming the clinical practice with optimal access and better outcomes for real world patients.
- Builds and facilitates close cross-functional equal partner collaboration with key internal stakeholders, co-creating and leading where necessary. Function as the key medical interface to Country President, Value & Access, TA Heads and BE&E Heads or similar position, GDD representatives, Public Affairs, and compliance teams as well as related Regional teams. In partnership with country Regulatory Affairs, develops and manages long-term relationships with local Regulatory agencies and relevant medical societies.
- Reactively supports HCP requests for deep clinical and scientific discussion around our therapy areas and products at all stages of the product lifecycle.
- Ensures BeSure approval for events/materials/initiatives used by the commercial, medical, access and TMO organization. Collaborates to upgrade capability of investigators, Ethics Committees etc.
**Capability Building and Internal** A**lignment**:
- Encourages earlier (starting at DDP) initiation of innovative integrated evidence generation strategies, novel research activities, and local collaborative and impactful partnership engagements. Supports utility of RWE innovative study designs and exploratory trials (where applicable) across TAs to accelerate patient access; oversight of Managed Access Programs (MAPs), IITs etc.
- In close collaboration with Global Drug Development (GDD), cultivates strategic and effective co-creation and collaboration plans, for allocation and execution of clinical trials within the country, as necessary. Incorporates local portfolio prioritization to shape GDD trial strategies and resource allocation. (only applicable for key markets).
- Encourages utility of more innovative digital technologies for more meaningful and impactful engagemen
-
Medical Manager
4 weeks ago
Midrand, South Africa Ultra Pharmaceutical and Medical Placements Full timeMultinational pharmaceutical company based in Midrand requires a Medical Manager ideally with Oncology and Anti Infectives experience. MBCHB qualification is essential.Qualifying Requirements Minimum 4-5 years relevant experience in a pharmaceutical or similar environment MBCHB, registered with the HPCSA or equivalent healthcare qualification Previous...
-
Associate Specialist, Regulatory Affairs
6 months ago
Midrand, South Africa MSD Full time**Basic Functions & Responsibility (may not be limited to)**: - Under supervision of the Country Lead/Senior Director/Director/Associate Director/Manager Regulatory Affairs, the incumbent is responsible for providing regulatory administrative support and coordination for the department with maintenance of tracking systems and databases, minor translations,...
-
Head of Regulatory Affairs
2 months ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob DescriptionJob Title: Head of Regulatory AffairsCompany: Emporium Human CapitalThe Head of Regulatory Affairs holds ultimate responsibility for the OTC division's regulatory activities and oversees the development and delivery of a fully integrated regulatory strategy for the business.Key Responsibilities:Drives the regulatory process to ensure timely...
-
Medical Lead Oncology
1 month ago
Midrand, South Africa Novartis Full time**Summary**: - In line with overall product strategy, the Medical Advisor is responsible for supporting the design, implementation and execution of Medical Affairs plans for assigned Therapy Area, providing scientific information, helping design & organise clinical studies, building educational dialogue with KOLs and regulatory stakeholders **About the...
-
Medical Advisor Infectious Diseases
6 months ago
Midrand, South Africa MSD Full timeOur Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry leaders ensuring the scientific value of our products is understood. We connect, communicate and train internal employees to ensure a thorough understanding of the science behind the medicine and review further unmet medical needs to...
-
Oncology Medical Advisor
3 months ago
Midrand, South Africa MSD Full timeThe Medical Advisor is a valued co-strategist on cross-functional country teams, with Marketing, Market Access and Policy. The role reports directly to the Oncology Medical Affairs Lead and will be responsible for the Oncology portfolio. **MAIN RESPONSIBILITIES** - Consolidate actionable medical insights from the country that can help inform company...
-
Medical Manager
4 weeks ago
Midrand, South Africa Jobted ZA C2 Full timeQualifying Requirements Minimum 4-5 years relevant experience in a pharmaceutical or similar environment MBCHB, registered with the HPCSA or equivalent healthcare qualification Previous experience in Oncology and Anti-Infectives will be advantageous Embodies our values and behaviours in all internal and external interactions Scientific expertise in relevant...
-
Medical Manager
4 weeks ago
Midrand, South Africa Ultra Personnel Full timeQualifying Requirements Minimum 4-5 years relevant experience in a pharmaceutical or similar environment MBCHB, registered with the HPCSA or equivalent healthcare qualification Previous experience in Oncology and Anti-Infectives will be advantageous Embodies our values and behaviours in all internal and external interactions Scientific expertise in relevant...
-
Medical Manager
4 weeks ago
Midrand, South Africa Ultra Personnel Full timeQualifying Requirements Minimum 4-5 years relevant experience in a pharmaceutical or similar environment MBCHB, registered with the HPCSA or equivalent healthcare qualification Previous experience in Oncology and Anti-Infectives will be advantageous Embodies our values and behaviours in all internal and external interactions Scientific expertise in...
-
Medical Director
4 weeks ago
Midrand, Gauteng, South Africa Ultra Pharmaceutical and Medical Placements Full timeJob SummaryWe are seeking a seasoned Medical Manager to join our team at Ultra Pharmaceutical and Medical Placements. As a key member of our medical affairs department, you will be responsible for providing medical and scientific insights in assigned therapeutic areas.Key ResponsibilitiesDevelop and implement strategies to support the sales force in...
-
Manager: Regulatory Affairs
2 months ago
Midrand, South Africa Jobted ZA C2 Full timeManager: Regulatory Affairs Market-related Salary Package Midrand, Gauteng Role Purpose The Manager for Regulatory Affairs reports directly to the Head of Public Policy and Regulatory. The role is responsible to manage all regulatory and compliance developments and affairs for company ensuring the group's understanding and adherence to relevant financial...
-
Head of RA
2 months ago
Midrand, South Africa Jobted ZA C2 Full timeHEAD OF REGULATORY AFFAIRS (OTC DIVISION) (POS24339) Midrand Salary: R 1,700 000 R 1,800 000 Purpose: The Head of Regulatory Affairs holds ultimate responsibility for the OTC divisions regulatory activities and oversees the development and delivery of a fully integrated regulatory strategy for the business. The Head of Regulatory Affairs will...
-
Head of RA
3 weeks ago
Midrand, South Africa Emporium Human Capital Full timeHEAD OF REGULATORY AFFAIRS (OTC DIVISION) (POS24339)MidrandSalary: R 1,700 000R 1,800 000Purpose:The Head of Regulatory Affairs holds ultimate responsibility for the OTC divisions regulatory activities and oversees the development and delivery of a fully integrated regulatory strategy for the business. The Head of Regulatory Affairs will additionally be...
-
Regulatory Affairs Director
2 weeks ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob DescriptionThe Head of Regulatory Affairs is responsible for driving the regulatory process to ensure timely filing of new products and variations in accordance with business and compliance objectives.Key ResponsibilitiesAdopt a risk-based assessment for all regulatory submissions and formulate regulatory risk mitigation strategies as...
-
Manager: Regulatory Affairs
2 months ago
Midrand, South Africa SET Recruitment Consultants Full timeManager: Regulatory AffairsMarket-related Salary PackageMidrand, GautengRole PurposeThe Manager for Regulatory Affairs reports directly to the Head of Public Policy and Regulatory. The role is responsible to manage all regulatory and compliance developments and affairs for company ensuring the group's understanding and adherence to relevant financial...
-
Manager: Regulatory Affairs
2 months ago
Midrand, South Africa Set Consulting Full timeManager: Regulatory AffairsMarket-related Salary PackageMidrand, GautengRole PurposeThe Manager for Regulatory Affairs reports directly to the Head of Public Policy and Regulatory. The role is responsible to manage all regulatory and compliance developments and affairs for company ensuring the group's understanding and adherence to relevant financial...
-
Manager: Regulatory Affairs
2 months ago
Midrand, South Africa Set Consulting Full timeManager: Regulatory Affairs Market-related Salary Package Midrand, Gauteng Role Purpose The Manager for Regulatory Affairs reports directly to the Head of Public Policy and Regulatory. The role is responsible to manage all regulatory and compliance developments and affairs for company ensuring the group's understanding and adherence to relevant financial...
-
Head of RA
2 months ago
Midrand, South Africa Emporium Full timeHEAD OF REGULATORY AFFAIRS (OTC DIVISION) (POS24339)MidrandSalary: R 1,700 000 – R 1,800 000Purpose:The Head of Regulatory Affairs holds ultimate responsibility for the OTC division’s regulatory activities and oversees the development and delivery of a fully integrated regulatory strategy for the business. The Head of Regulatory Affairs will additionally...
-
Head of RA
2 months ago
Midrand, South Africa Emporium Full timeHEAD OF REGULATORY AFFAIRS (OTC DIVISION) (POS24339)MidrandSalary: R 1,700 000 – R 1,800 000Purpose:The Head of Regulatory Affairs holds ultimate responsibility for the OTC division’s regulatory activities and oversees the development and delivery of a fully integrated regulatory strategy for the business. The Head of Regulatory Affairs will additionally...
-
Regulatory Affairs Specialist
1 month ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob Title: Regulatory Affairs PharmacistEmporium Human Capital is seeking a highly skilled Regulatory Affairs Pharmacist to join our team. The ideal candidate will have a strong background in regulatory affairs, with experience in human medicines, including complementary medicines and medical devices.Key Responsibilities:Manage end-to-end regulatory...