Medical Advisor
2 days ago
Applicants are invited for the above-indicated vacancy that exists in the **Medical Division (Oncology)**. The incumbent will report into the Affiliate Medical Sr Manager.
**Company Description**
We are a global specialty and branded pharmaceutical company, improving the health of patients across the world through our high quality and affordable medicines. Active at every stage of the value chain, we are uniquely diversi?ed by geography, product and manufacturing capability.
Aspen is a dynamic organisation built on entrepreneurial strength and forward-thinking minds. We attract high performing individuals who are passionate about their career and have a desire to exceed expectations. At aspen, not only do we source for the best talent but we also provide a host of opportunities for continuous development.
The Group’s key business segments are Manufacturing and Commercial Pharmaceuticals comprising Regional Brands and Sterile Focus Brands. We have approximately 9 100 employees at 69 established offices in over 50 countries and we improve the health of patients in more than 150 countries through our high quality, affordable medicines.
**MAIN DUTIES**:
- Product(s) lifecycle management ?
- Leading and developing the Local Medical strategy and medical activities for the product(s) in accordance to internal and external regulations?
- TA and/or product specific medical training ?
- Management of internal and external relationships within area of responsibility?
- Ensuring consistency of medical content and scientific messages across various tools and materials?
- Works with Local DFO to ensure preparation, implementation and completion of local studies.
- Develops study protocols and data analysis plans for Local studies; supports and executes Local study protocol preparation, filing, review and approval in line with internal and external processes and policies?
- Participates in the development of strategy and tactics in close collaboration with the Medical Senior Manager
- Visits selected KOL’s and study groups for strategic discussions and protocol development?
- Reviews Local ISS proposals prior to approval and ensures appropriate Local review prior to IPRC submission, if applicable?
- Partners with the BU Manager in the development and execution of the Local product(s) lifecycle management plan?
- Provides input into site selection for local studies
- Oversees in-sourced/outsourced medical programs and logistics?
- Supports Local regulatory and ethics approvals for development protocols ?
- Develops and executes better recruitment strategies in conjunction with Local clinical development team team?
- Participates in/conducts Local Advisory Board Meetings, Investigator Meetings and/or Expert Panels?
- Provides Medical expertise for pipeline products?
- Provides Medical expertise for Health Economy and reimbursement requests?
- Member of the Local Development Team (LDT)?
- Provides relevant training to internal and external stakeholders
**Authority**
- Signs off medical plans for his/her area of responsibility?
- Approves scientific content of Local symposia/workshops/publications/ promotional materials/medical section of reimbursement files
**Outputs**
- Brand/disease specific parts of medical plan?
- Local support for medical questions, feasibility and trial strategy?
- Local Product Lifecycle Plan ?
- Protocols and other study documents for local studies?
- Medical expertise for the review of promotional and scientific documents (e.g. symposia, publications etc.)?
- Local R&D brand/disease related results according to goals and metrics
- Provide relevant training to internal and external stakeholders
**QUALIFICATION AND EXPERIENCE**:
**Qualifications**
- Matric/Grade 12
- MBChB, or relevant life science qualifications i.e. B.Pharm, or a specialist BSC
**Minimum Requirements**
- Minimum of 2 years in pharmaceutical industry, or proven industry collaboration in academia ?
- Experience in affiliate Medical Department or Clinical Development?
- Experience with clinical study management and conduct?
- Knowledge of commercialization and business practices?
**Preferred Requirements**
- Knowledge of pharmaceutical product development, product lifecycle and commercialization process with advanced understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Regulatory, and Medical Affairs?
- Experience in the Oncology therapeutic area will be advantageous
- Network of customer contacts in therapeutic area??
**Competencies**
- Medical strategy and scientific expertise?
- Fluency in English, both oral and written communications?
- Strong communication and presentation skills?
- Continuously expanding medical and scientific knowledge as well as market knowledge?
- Strong clinical research knowledge (study design, study evaluation, medical writing skills, expert panel conduct, symposium and workshop management, KOL management)?
- Strong customer orientation; science-b
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