Jobs at Aspen Pharma Group

OBJECTIVE OF ROLE

• To support the SA Commercial Business to realise the commercial strategy and to achieve the annual targeted growth and revenue through successful new product introductions and maintenance of current product portfolio in the South Africa and South African Development Community (SADC) region, by ensuring successful Marketing Authorisation and variation approval from the SAHPRA and  Regulatory Authorities of the SADC member states within the committed timeframe.
• To ensure Aspen Pharmacare’s SA product portfolio complies with the related Acts and guidelines to support and maintain registration in South Africa.  To ensure growth and sustainability of Aspen Pharmacare’s SA product portfolio within the legislative framework of the country and in compliance with the company strategy.
• The role undertakes responsibility for compliance with the Regulatory Medical Information and Compliance requirements for the New Product Launch Pipeline and the existing  product portfolio in the region, through the successful completion of assigned activities according to the South African and SADC Regulatory plan.
• To perform Medical Information and Compliance monitoring activities for Aspen in accordance with procedural documents and relevant governing group policies.
• To meet the needs of healthcare providers and patients/consumers through collaboration with internal customers to ensure delivery of accurate and scientifically balanced medical information, and promotional and non-promotional material, and to respond to unsolicited inquiries from regulatory authorities,  including clients and managed healthcare organisations in a manner that will help them make a decision regarding therapy for a patient or product selection.

KEY RESPONSIBILITIES
FINANCIAL 

• Effective utilisation of resources to keep processes cost effective.
• Adhering to Regulatory Affairs budget and forecasts.

MEDICAL INFORMATION (MI)

• Providing support within the MI function in responding to labelled and off-label medical information enquiries for Aspen and contractual partners.
• Providing compliant responses to internal and external customers.
• Creating and maintaining standard responses (SRs) and Objection Handlers (OHs).
• Ensuring that the relevant department/s are informed in a timely manner (at receipt or at least within 24 hours) following the receipt of adverse events or product quality complaints/potential counterfeit medicines.   This include performing a daily check on the dedicated medical information inbox and MAfax inbox.
• Ensuring that Affiliate/Distributor/MI is adhering to Aspen’s Policy in providing scientific support to internal and external customers.
• Identifying gaps and suggesting ways of process improvement in MI.
• Ensuring that the reconciliation between the Medical Information function and Pharmacovigilance and the Quality department is effective by performing ad hoc reviews on reconciliation files.
• Ensuring that any suggested improvements within the professional information and/or patient information leaflets are communicated to the PV Lead at the point of identification.
• Supporting the line manager in generation of medical information reports showing trends in medical information enquiries received.
• Managing after hour MI enquiries on a rotational basis.
• Ensuring telephony system testing documents are completed as per allocation.
• Ensuring compliance to Key Performance Indicators (KPIs) response timelines.  
• Ensuring a professional attitude is displayed when responding to a customer’s needs.

PROMOTIONAL MATERIAL, SCIENTIFIC MATERIAL REVIEW AND COMPLIANCE MONITORING

• Reviewing and approving promotional material relating to the advertising and promotion of medicines and related products for the SA and SADC markets in compliance with applicable legislation, codes of practice and any other applicable regulations/guidelines and corporate requirements.
• Reviewing and approving educational, scientific and other non-promotional material for the SA and SADC markets in compliance with applicable legislation, codes of practice and any other applicable regulations/guidelines and corporate requirements.
• Liaising with marketing divisions regarding advice, queries, and timelines in relation to the above. 
• Assisting with the review of information relevant to each product. 
• Attending promotional campaign concept presentations at the request of the marketing teams to provide regulatory support and input.
• Ensuring that compliance monitoring is performed on all territories and non-compliances are escalated in a timely manner to the line manager as per Aspen group policies.
• Supporting the line manager in developing and maintaining procedural documents for compliance monitoring.
• Supporting the training department in providing recommendations for improvement and compliance with Aspen group policies following compliance monitoring review.
• Supporting the line manager in generating reports associated with compliance monitoring activities.

REGULATORY AUTHORITY SUBMISSIONS (INCLUDING SECTION 21/36):

• Performing clinical due diligence for new intellectual property as received from the regulatory function.
• Creating Professional Information (PI) and Patient Information Leaflets (PILs) for new IP.
• Creating company core data sheets.
• On time responses to clinical evaluation recommendations (CERs) and clinical screening enquiries.
• Accurate compilation and filing of the electronic submission documentation.
• Accurate completion of all tasks pertaining to submissions as specified in the relevant procedural documents.
• Maintaining tracking tools to ensure on time submission and reporting.
• Identifying process enhancements.
• Ensuring accurate uploading of the current approved PIs and PILs to the SA Regulatory Portal and submission to SAHPRA for uploading to the PI/PIL Repository (and relevant platforms).
• Managing Section 21 and 36 submissions.

IMPLEMENTATION OF RISK MANAGEMENT PLAN (RMP) MATERIAL:

• Ensuring that RMP material is created, maintained and rolled out to market.
• Ensuring that the relevant sales force team is adequately trained, and training records are filed.
• Ensuring that tracking tools are in place to ensure logging of material distribution and reporting to SAHPRA. 

PRINTED PACKAGING/ARTWORK 

• Reviewing and approving concept of new or updated artwork/printed packaging material for medicines and related products for the SA and SADC markets in compliance with applicable legislation and corporate requirements. 

AFRIKAANS TRANSLATION OF PROFESSIONAL INFORMATION (PI) AND PATIENT INFORMATION LEAFLETS (PILs) 

• Assisting with the translation and/or validation of Afrikaans PIs (where required) and PILs for both new and existing products.
• Ensuring that translations are undertaken accurately and timeously.

PROJECT MANAGEMENT 

• Providing assistance with any specific projects and operational support for the MI and Compliance team

MAINTENANCE OF THE ASPEN MEDICALLY CRITICAL LIST

• Initiating and finalising a bi-annual review of the Aspen medically critical list.

QUALITY MANAGEMENT SYSTEMS

• Maintaining procedural documents for the Medical Information and Compliance function as specified in the individual KPAs (as per identified     subject matter expert/s).
• Ensuring accurate and ‘real-time’ filing of training records.
• Ensuring ‘real-time’ maintenance of TrackWise/QAlign records. 
• Ensuring that relevant documentation requested by auditors is provided in a timely manner during internal and external audits.
• Ensuring that training records are up to date to ensure audit readiness.
• Ensuring that the commercial team members are trained on those RA:SQC procedures where there are shared responsibilities.

GENERAL

• Ensuring systems and procedures are in place in accordance with the RA QMS and that these are maintained according to the relevant SOPs.
• Adherence to agreed Key Performance Indicators (KPIs).
• Supporting the continuous development and improvement of the Medical Information and Compliance function while upholding Aspen core values.
• Ensuring relevant records are maintained as soft copies and hard copies, as per Pharmacare filing structure/instructions.
• Adherence to Company Health & Safety procedures.
• Participation in training programmes. 
• To provide a leadership role as required by taking responsibility for specified areas and coaching of staff.
• Any other duties as assigned by Manager.

Requirements
EDUCATIONAL REQUIREMENTS

• Bachelor of Pharmacy Degree and registration with the South African Pharmacy Council

KNOWLEDGE AND EXPERIENCE REQUIREMENTS

• Minimum 1 to 2 years’ pharmaceutical experience
• Experience in Medical Information is an advantage
• Ability to work with multi geographical locations & time zones
• Experience in medicine legislation and related guidelines and codes of practice preferable
• Regulatory Authority requirements/legislation
• Understanding of the laws and requirements governing the marketing of medicines and printed packaging Guidelines and codes of practice
• Understanding requirements of medical information and information management
• Terminology – understanding the jargon
•  Understanding business processes
•   Product knowledge
•   Industry knowledge
•   Dossiers and requirements
•   Multilingualism (including Afrikaans) would be an advantage

SOFT SKILLS REQUIREMENTS

• Integrity, good work ethic and ability to meet deadlines
• Self-starter
• Analytical and planning skills
• Accuracy and attention to detail
• Effective organisational skills and ability to prioritise
• Ability to work under pressure and to tight deadlines
• Ability to work in a fast-paced international environment
• Ability to manage projects in a matrices team environment and  with both internal and external partners
• Willing to travel if required
• Presentation skills
• Time management skills
• Service orientation
• Decision making skills
• Customer focused
• Self-confidence
• Organisational awareness
• Information seeking
• Excellent interpersonal and communications skills
• A solutions provider
• Manage evolving deadlines effectively with regular feedback  and updates
• Enthusiasm and drive to take ownership and drive process  initiatives
• Logical thinking
• Positive ‘can – do attitude’
• Work autonomously and have good problem-solving skills
• Honest and trustworthy
• Respectful and highly personable
• Possess cultural awareness and sensitivity
• Flexibility and confidentiality
• Empathy, patience, influence
• Sense of urgency
• Positive and pro-active approach to business tasks
• Business process analysis
• Report writing
• Information gathering and monitoring
• Projects (advantage)

 COMPUTER SKILLS REQUIRED

• Effective use of appropriate IT systems and programs 

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Description

• Fine Chemicals Corporation requires the services of a Project Technician for our Engineering Department.

Requirements
Overview

• To provide planning, project co-ordination and execution in support of engineering and capex project activities.

Responsibilities

• Assist, plan and co-ordinate designated engineering projects or sub-sections of designated engineering projects. This includes coordinating with FCC Departments and relevant project consultants and other service providers/ contractors.
• To manage, control and co-ordinate project activities (including contractor management) and ensure continued compliance with project schedules and company procedures and relevant standards.
• Create, plan and monitor project schedules including regular reporting.
• Control of drawings, specifications and documents related to projects.
• Assist with the RFQ and procurement process for projects.
• Control and report on relevant project expenditure within CAPEX approvals.
• Assist in developing and preparing engineering plans, diagrams and layouts.
• Ensure sustained adherence to cGMPs and OHSE regulations during design and implementation of project activities.

Skills Required

Background/Experience

• N-Dip Engineering (Mechanical, Chemical Engineering or relevant mechanical or structural drafting qualification.
• Project Management qualification would be advantageous.
• Min 2 - 3 years’ experience within the engineering field in the chemical/pharmaceutical/FMCG industries with specific focus on project engineering and drawing office management.

Competencies/Personal Attributes

• An assertive individual with good communication and interpersonal skills who thrives under pressure.
• Must be able to train and develop trainees and build capacity.
• Ability to work independently as well as a team.
• Ability to prioritize and multitask, however, must be systematic and analytical in reasoning.

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OBJECTIVE OF ROLE

• To manage, lead and develop Public Healthcare for Aspen in South Africa 

KEY RESPONSIBILITIES

FINANCIAL 

• Manage and control budgets:
• Public Healthcare ± R1 billion 

COMMERCIAL 

STRATEGIC AND BUSINESS PLANS

• Determine strategy within the framework of the company to ensure growth and development
• Compiling of Annual Business Plans to ensure the implementation / control / achievement of these
• Ensure communication and understanding of Business Plan throughout the division
• Ensure optimal operational and strategic alignment with manufacturing sites 

FINANCIALS

• Achievement of Sales / Growth vs Budget
• Gross margin and operating income
• Control of expenses within Budget
• Forecasting, close co-operation and communication with Supply Chain
• Ensure Stock Level policy and controls in place
• Collection / compilation / maintenance of a market database for the responsible markets
• Compilation of Product Target Costs for future action to communicate with all
• To constantly work towards a balance between Turnover / Margin and Volumes for factory recoveries
• Strategy and pricing of Tenders 

NEW BUSINESS DEVELOPMENT

• Market / Product needs should be researched / analysed, communicated / motivated / activated and mentored
• Develop and responsible for information sharing programs 

COMPANY IMAGE

External

• Responsible to broaden and strengthen the value and role of the company / product as a preferred customer and product.
• Improve the perception of the department within the division, the people and the corporate image.

Internal

• Promote / develop company / division strategies and values
• Develop the image / perception of division and people 

CORPORATE SOCIAL DEVELOPMENT PROGRAMS

• Projects – initiate and launch programs
• To interact with opinion leaders / competitors and organizers
• To lead and influence Health Care initiatives at all levels 

STRATEGIC ALLIANCES

• Have professional body interaction
• Political contact
• Competitor contact 

STRATEGIC PROJECTS

• To project plan for strategic projects
• Costs
• Obtain / communicate approval for plans 

HR

• Have performance management systems / contracts and company requirements in place and ensure they are operational
• People development program in place
• Succession plan in place
• Competency / Oblique Personnel Development Training
• CSI targets are compiled and met 

LEARNING AND GROWTH 

Provide ongoing assessment and feedback of development.

• Learning achievements are acknowledged to improve staff performance and motivation.
• Team effectiveness is facilitated and assessed against standards and contingencies applied when required.
• On the job assessment and feedback occur timeously. 

Resolve IR issues

• Performance issues are accurately identified and action is instituted.
• Potential conflict is resolved according to IR procedures.
• Disciplinary action is taken according to the IR policy – in cases of extreme poor performance and inappropriate behaviour by staff. 

Identify development / training needs of self and team. 

• Staff performance is monitored against standards and regular feedback is provided.
• Individual goals are developed and aligned to team goals and roles are clearly defined as per role profile.
• Performance discussions are held regularly to identify learning requirements.  

Requirements
EDUCATIONAL REQUIREMENTS

• Post graduate Commerce or related degree 

KNOWLEDGE & EXPERIENCE REQUIREMENTS

• 5 - 10 years’ experience within the public sectors
• 5 - 10 years’ experience managing a business unit
• Knowledge and experience in aspects of : Finance, Legal
• Exposure and knowledge of local and international Tender process
• International exposure
• Regulatory exposure
• Networking at all Government levels related to Health i.e. Tender Board / State Treasury / Medical Control Board /Department of Health / Trade and Industries
• Knowledge of Business
• Knowledge of processes
• Recruitment and selection
• Policy and procedure
• Finance knowledge
• System knowledge
• Product knowledge
• Industry knowledge
• Legal Knowledge
• Tender knowledge
• Career pathing 

COMPUTER SKILLS REQUIRED

• The applicant must be proficient in the various applications (Word, Excel and PowerPoint) within the Microsoft Office bundle.

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OBJECTIVE OF ROLE

• Heading up the Independent Key Accounts division by developing the strategy and business plans. Driving strong business relationships within the independent channels to ensure sales is a high priority, with sustainable and profitable growth.

KEY RESPONSIBILITIES

• Develop business plans
• Negotiate with independent customers the SLA for the financial year.
• Create Service level agreements
• Remediation and Compliance to contracts
• Accurately Forecast sales and data fees.
• SOH report with Forecast landing projector
• Strategic relationship with customers (Customer Services)
• Report the performance of the business unit at an executive level.
• Developing and Driving the people strategy.
• Financial Objective
• Performing additional work outputs and Cross Collaboration related to the role as required:
• Authorisations and sign-offs
• Identify, initiate, and create requirements for the divisions QlikView models to be developed via business intelligence.

Requirements

EDUCATIONAL REQUIREMENTS

• Sales and marketing bachelor’s degree.
• Post bachelor’s degree preferred 

KNOWLEDGE & EXPERIENCE REQUIREMENTS

• Min 5-10 years Sales / Marketing experience.
• Min 5 years Strong Management experience.
• 3-5 Years’ experience in setting and strategizing of departmental budgets including Forecasting
• 3-5 Years’ experience in customer negotiations i.e., Contracts
• Computer literate (MS Office, Word, PowerPoint)
• The suitable candidate for the position will also have substantial expertise in Customer Relationship Management in Pharmaceutical Key accounts.

Computer skills:

• Ms Office:  Advanced Excel (Formula calculations)
• PowerPoint, which are necessary for the creating reports and communicating internally and externally to all stakeholders.
• A solid understanding of the Pharma Industry (competitors and market positioning)
• Knowledge of finance and budget handling.
• Knowledge of different data sources
• Deep technical knowledge of project management, data analysis, and business intelligence
• Ability to interpret financial modelling
• Vast experience on managing of Independent Key Accounts channel.
• Understanding of the Marketing code, ensure compliance is adhered to.
• Vast understanding of Independent contracts negotiating contracts ensuring they comply to legislation and that services are received. 

SOFT SKILLS REQUIREMENTS

• Results driven
• Influencing capabilities.
• Independent and self-directed individual that can drive execution.
• Highly numerate, strong analytical skills
• Project management skills; Commercial implementations in Key account
• Ability to think strategically and innovatively
• Strong capabilities to learn quickly
• Effective problem solving and decision making
• Commercial and strategic awareness
• The ability to communicate effectively (written and verbal) is essential.
• Strong sales track record and sound organizational skills.
• Ability to lead and mentor KAM’s.
• Proven leadership competencies. Able to make difficult decisions.
• Commercial and strategic awareness
• Well-developed negotiation skills and competencies 

COMPUTER SKILLS REQUIRED

The applicant must be proficient in the various applications (Word, Excel and PowerPoint) within the Microsoft Office bundle. 

The successful candidate must have a valid driver’s license and be able to travel as per the expectations of the role.