Medical Advisor

2 weeks ago

Cape Town, South Africa Cipla Full time

**Division**:
Regulatory Affairs

**Department**:
Medical Affairs

**Employment Type**:
Permanent

**Job Purpose**:
South Africa and Sub-Saharan Africa:
Develop, control and shape strategies for all therapeutic areas; provide and ensure dissemination of ethical, scientifically correct and balanced information for execution to the respective stakeholders; provide cross-functional support to relevant business units; and build, support and maintain the Cipla brand.

**Accountabilities 1 and 2**:
**Provide medical support to the Commercial (Marketing and Sales) team with relevant information to contribute to the execution of the commercial strategy to achieve business objectives for SA and SSA**:

- Develop a comprehensive commercial strategy in partnership with the commercial team, based on a clear understanding of available data, key competitors, current medical practices, trends and patient needs for existing and new products
- Execute commercial strategy
- Provide scientific support for the creation of marketing material for existing and new products
- Guide, review and approve all marketing, educational, corporate communication and training material in accordance with applicable laws, regulations and internal procedures
- Respond and resolve the concerns or issues that arise from marketing activities
- Mitigate potential risks arising from commercial activities
- Formulate scientific agenda and identify appropriate speakers for various medical CMEs, Cipla-led scientific meetings, round table discussions, etc.

**Training**
- Provide support to Training department:

- Create relevant clinical training material for therapeutic areas
- Evaluate and review all training content
- Train new and existing sales representatives to build capacity by providing a deeper understanding of the disease entity/therapeutic area
- Train other staff members to improve skill sets, when required

**Accountabilities 3 and 4**:
**Provide support to Regulatory Affairs**:

- Provide the scientific input required to ensure dossier submission
- Provide the scientific input for appropriate responses to regulator queries raised
- Provide medical/clinical motivations for molecule registrations (“expedited review”)
- Provide guidance for regulator-related communication e.g. medical review of updated package insert information

**Contribute to pharmacovigilance (PV) in SA and SSA by line management of the Drug Safety Officer and providing medical expertise and facilitating reporting and evaluation of product complaints with respect to quality and SAEs, to ensure drug quality and safety**:

- The Drug Safety Officer (DSO) reports to the Medical Advisor
- Received product-related complaints are forwarded to the DSO/QA team for appropriate action
- Provide necessary medical expertise to the DSO to evaluate SAE’s.

Medical Executive _ Medical Affairs Page 3- Support the DSO in ensuring regular training of employees in accordance with Company procedures and relevant guidelines.
- Coordinate with the external stakeholders (doctor, patient, pharmacist, etc.) to obtain necessary information in ambiguous/ critical cases.
- Support the DSO in ensuring that safety data exchange agreements are in place and valid with all relevant 3rd parties, and are aligned to Company procedures and compliant with relevant legislation
- Review monthly PV reports and submissions to the Regulator

**Accountabilities 5 and 6**:
**Support the development of a robust portfolio by identifying gaps and understanding and keeping abreast of the changing therapy landscape, to have an appropriate product mix and pipeline for the company**:

- Remain abreast with the latest therapy market trends by continuously reading related material and attending national and international conferences- Evaluate and suggest new products to SA and SSA business teams in line with the changing treatment paradigms and new developments in therapy, guidelines and modalities
- Suggest incremental innovations for lifecycle management of marketed products
- Review and provide medical opinion on products that are suggested by other stakeholders such as business development, portfolio and commercial for SA and SSA.
- Participate in discussions for in-licensing of products with prospective clients/ companies
- Participate actively with the Project Management Office (PMO) activities for all product launches

**New Business Support e.g. TEVA, Dr Falk, Mirren**:

- Guide, review and approve all marketing, educational, corporate communication and training material in accordance with applicable laws, regulations and internal procedures
- Drafting and reviewing of SOPs
- Medical support for new product launches

**Accountabilities 7**:
**Develop and manage internal and external stakeholder and cross-functional relationship to ensure medical support and provide value to the business**:

- Continuous medical knowledge development and maintenance for therapeutic areas- Identify and develop key relationships

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