OBJECTIVE:
To provide state-of-the-art medical insight into the therapeutic area (TA) and/or specific molecules to Local and International teams.
?MAIN DUTIES:
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- 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 AST’s (Amgen sponsored studies)?
- Develops study protocols and data analysis plans for Local AST’s; supports and executes Local study protocol preparation, filing, review and approval in line with Amgen processes and policies?
- Supports Local DFO in participation and completion of international development studies in the country?
- Participates in the development of international strategies and tactics in close collaboration with the IML?
- 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 AST’s
- 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 DFO 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)?
Authority
- Signs off Local R&D plan for his/her area of responsibility?
- Approves scientific content of Local symposia/workshops/publications/ promotional materials/medical section of reimbursement files?
- Signs off Direct Outside Expenses at signature level?
Outputs
- Brand/disease-specific parts of Local R&D plan?
- Local support for medical questions, feasibility and trial strategy?
- Local Product Lifecycle Plan ?
- Protocols and other study documents for local AST?
- 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
QUALIFICATION AND EXPERIENCE:
Qualifications
- Matric/Grade12
- MBCHB, BPharm, or a specialist BSC
Minimum Requirements
- Minimum of 2 years in the 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 an advanced understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Regulatory, and Medical Affairs?
- Therapeutic area knowledge ?
- Network of customer contacts in the therapeutic area?
- Finance and budgeting experience?
Competencies
- Medical 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-based ?
- Ability to work in a cross-functional team (e.g., Commercial, Clin Development, EU teams, HE, Regulatory, Safety, etc.)?
- Role model for others in line with Amgen Values?
- Demonstrates leadership skills?
The job applicant acknowledges, agrees, accepts, and understands that the Company (Pharmacare Limited t/a Aspen Pharmacare), has a mandatory Covid-19 Vaccination Policy and Plan which, inter alia, provides for mandatory vaccination for all employees at SA Commercial. Mandatory Covid-19 vaccination applies to this job vacancy. As such, in applying for and if applicable accepting an offer of employment for this job role, the applicant warrants that s/he is fully vaccinated, and that his/her vaccination status is valid and up to date. The Job applicant’s electronic vaccination certificate, as issued by the NDOH, must be provided if the job application results in an offer and subsequent acceptance of this offer of employment. The applicant acknowledges, further, that there is no particular reason that he/she would refuse any future booster or vaccination requirements that may/should be recommended by the South African health authorities.
Aspen is committed to the principles of equal employment opportunity and suitably qualified job applicants are invited to submit their CV online on or before the 25 July 2023. Preference will be given to applicants from designated groups through a fair recruitment and selection process in accordance with laws governing employment equity, where such laws are applicable to the Aspen
