Aspen has a proud heritage dating back more than 160 years and is committed to sustaining life and promoting healthcare through increasing access to its high quality affordable medicines and products. Aspen has a market capitalisation of approximately US$10 billion, is the largest pharmaceutical company listed on the JSE Limited (share code: APN) and rank...
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Description
Overview
- Lead supplier development, supplier negotiations, RFQs, and CMO category strategy for major suppliers.
- Identification of continuous improvement opportunities.
Responsibilities
Supplier management
- Communicate and negotiate with suppliers
- Monitor quality standards and identify performance failures
- Conduct supplier audits and report on supplier performance
- Manage supplier communications and documents and process flow, including RFIs, RFP, RFQ, and RFB’s
- Resolve supplier issues; maintain working relationships with key suppliers
- Set up new vendors and coordinate with legal to support new contracts; maintain/ update existing contracts
- Identify new suppliers and products in the marketplace
- Vet potential suppliers’ capabilities (delivery, quality, services)
- Review insourcing and outsourcing opportunities
- Negotiate with suppliers to carry stock for fast moving items
- Assist in the drafting of specifications as required, and provide advice and guidance to customers on procurement processes
- Review and approve price variances (Order vs Invoice Prices)
- BBBEE and procurement administration
Risk management
- Maintain and report on adherence to internal and external compliance requirements
- Actively reduce third-party risk exposure
- Carry out risk management processes within CMO category
Quality and qualifying products
- Assist quality teams to obtain products needed to conduct finished product testing
- Schedule product trials and coordinate samples.
- Reporting and record-keeping
- Maintain repository of procurement-related knowledge
- Maintain complete, compliant documentation of purchasing activities
- Maintain standards and update SOPs for documentation and filing requirements
Budgeting
- Manage and optimise use of Category budget
- Provide input into required changes in resources to enable achievement of objectives
- Monitor, track and report on expenditure against budget
Planning and coordination
- Optimise processes, identify gaps in policies, procedures and legislation, and propose changes or improvements to management
- Provide technical advice to internal stakeholders
Requirements
Background/experience
- 6 years' relevant experience
- Experience in a manufacturing procurement environment, and preferably with significant experience in a CMO environment
- National Diploma in relevant field (Procurement, Logistics, Supply Chain Management, Finance), or a related discipline
Specific job skills
Competencies
- Customer Awareness
- Meeting Deadlines
- Making Decisions
- Planning and Organising
- Interrogating Information
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Description
- Monitor manufacturing compliance to GMP and statutory requirements
- Monitor adherence to guidelines, procedures, and document controls
- Deliver expected productivity targets as per business requirements
- Related administrative tasks
- Serve as back up to Team Leader on shift
Requirements
Planning and Procedures
- Plan and prioritise daily, weekly, and monthly activities
- Determine, request, and use resources/ assets optimally
Inspections and Verifications
- Verify schedule 5 products
- Verify certified clean status of rooms and equipment
- Verify, review, and approve verification of measuring equipment performance, calibrations, and sampling, and dispensing of materials
Line & Production processing
- Perform, review, and approve line sign on’s, closures and clearance authorisations
- Perform, review, and approve batch reconciliations to product specifications and quality
- Ensure production process adherence to standards and specifications
Process and system improvements
- Manage, review, and approve change control programs and deviations/ concessions comply to standards and specifications
- Manage and resolve customer complaints
- Optimise processes and identify gaps in policies/ procedures
- Drive CAPA investigations in area of focus
Compliance & Auditing
- Perform and review shift GMP checks, environmental checks, and agent expiry dates, and ensure continued compliance
- Verify good document practice as per SOP and regulation
- Verify the identity of bulk product and printed packaging materials, and conduct intermix checks to assess uniformity
- Verify IPCs are in line with product quality and specifications
- Review and approve preliminary batch records
- Audit logbooks and systems
Troubleshooting
- Investigate deviations and concessions, and assess risk
- Raise deviations and implement corrective action
- Raise maintenance notifications as and when required
Training and technical expertise
- Train new Pharmacists and PMAs on SOPs in transition period
- Identify refresher or awareness training needs
Administration & Record keeping
- Complete batch records and labels
- Complete deviation forms as required
- Query documents and sign off declarations
- Perform and verify calculations in BMR
- Maintain and update records and systems as required
- Retrieve supporting documentation and records to facilitate and support query resolution
Skills required
Background/experience
- BPharm Degree
- 1-3 years’ related work experience
- Pharmaceutical manufacturing experience
Specific job skills
- Comprehensive knowledge of pharmaceutical manufacturing, standards, and compliance requirements
- Ability to interpret and implement policies, processes, and objectives
Competencies
- Information gathering
- Interrogating information
- Meeting deadlines
- Finalising output
- Taking action
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Description
- Operate equipment in the manufacturing and packing of products.
- Prepare, clean, and inspect work areas and equipment.
- Troubleshoot machines and raise maintenance issues.
- Carry out required training and administrative tasks.
Requirements
Operational Support
- Identify gaps in current policies and procedures
- Optimise and facilitate implementation of processes
- Operate equipment as per standards and expected efficiency, and ensure compliance to GMP and SHE standards
Inspections & Verifications
- Perform pre-production checks such as environmental, scale and equipment pre-checks as per BMR, SOP and product specifications
- Verify scale and measuring equipment performance
Production Preparation
- Ensure availability of materials and equipment for manufacturing
- Perform Type-A and Type B changeovers; Clean and prepare the area and equipment before and after processing
- Prepare solutions for production activities as per SOP
Production Processing
- Clear and feed the manufacturing line
- End of line packing and inspections
- Perform central lining review to establish optimal production settings
Routine Support Tasks
- Clean area and equipment before and after processing of materials
- Perform equipment pre-checks and facilitate transfer of equipment
- Sort defected product and dispose of according to procedures
- Provide information to assist with campaign preparation
- Train new Assistants and Operators and transfer of skills
- Operate manufacturing and packaging lines as per requirements
- Resolve minor - and assist with major breakdowns/ maintenance
- Perform change overs, settings, and minor maintenance as per autonomous maintenance standards
Troubleshooting
- Conduct root cause problem analysis on machines
- Raise maintenance issues with management for resolution
- Perform adjustments and preventative maintenance on machines
Reporting & Record Keeping
- Complete batch record labels and OEE sheets
- Perform half-hourly inspections of production area(s)
- Record manufacturing/ machine down time
- Attend shift meetings
- Perform IPQC or quality inspections per responsible areas
- Provide information for reports; consolidate standard documents
- Maintain and update records and systems as required
Skills required
Background/experience
- National Certification (N3)/ Matric/ National Senior Certificate (NSc)/ NQF 4 with 0-2 years’ related experience
- Manufacturing experience
Specific job skills
- Basic technical knowledge of pharmaceutical production processes, procedures, systems, and equipment.
- Basic understanding of pharmaceutical standards and compliance requirements
Competencies
- Finalising outputs
- Following procedures
- Taking action
- Information gathering
go to method of application »
Description
Overview
- Lead supplier development, supplier negotiations, RFQs, and CMO category strategy for major suppliers.
- Identification of continuous improvement opportunities.
Responsibilities
Supplier management
- Communicate and negotiate with suppliers
- Monitor quality standards and identify performance failures
- Conduct supplier audits and report on supplier performance
- Manage supplier communications and documents and process flow, including RFIs, RFP, RFQ, and RFB’s
- Resolve supplier issues; maintain working relationships with key suppliers
- Set up new vendors and coordinate with legal to support new contracts; maintain/ update existing contracts
- Identify new suppliers and products in the marketplace
- Vet potential suppliers’ capabilities (delivery, quality, services)
- Review insourcing and outsourcing opportunities
- Negotiate with suppliers to carry stock for fast moving items
- Assist in the drafting of specifications as required, and provide advice and guidance to customers on procurement processes
- Review and approve price variances (Order vs Invoice Prices)
- BBBEE and procurement administration
Risk management
- Maintain and report on adherence to internal and external compliance requirements
- Actively reduce third-party risk exposure
- Carry out risk management processes within CMO category
Quality and qualifying products
- Assist quality teams to obtain products needed to conduct finished product testing
- Schedule product trials and coordinate samples.
- Reporting and record-keeping
- Maintain repository of procurement-related knowledge
- Maintain complete, compliant documentation of purchasing activities
- Maintain standards and update SOPs for documentation and filing requirements
Budgeting
- Manage and optimise use of Category budget
- Provide input into required changes in resources to enable achievement of objectives
- Monitor, track and report on expenditure against budget
Planning and coordination
- Optimise processes, identify gaps in policies, procedures and legislation, and propose changes or improvements to management
- Provide technical advice to internal stakeholders
Requirements
Background/experience
- 6 years' relevant experience
- Experience in a manufacturing procurement environment, and preferably with significant experience in a CMO environment
- National Diploma in relevant field (Procurement, Logistics, Supply Chain Management, Finance), or a related discipline
Specific job skills
Competencies
- Customer Awareness
- Meeting Deadlines
- Making Decisions
- Planning and Organising
- Interrogating Information
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Description
- Fine Chemicals requires the services of a highly competent Regulatory Affairs Administrator for the Regulatory Affairs Department. To qualify for this position, the most suitable candidate must fulfil the following requirements:
Requirements
JOB REQUIREMENTS:
- A minimum of Grade 12 with mathematics and science
- Must have or be studying towards a National Diploma in Chemistry or equivalent
- Demonstrable enthusiasm for working in a highly regulated and technical environment related to the chemical manufacturing of Active Pharmaceutical Ingredients (APIs).
- Knowledge of local and international pharmaceutical regulations and guidelines would be advantageous.
- Excellent written and verbal communication skills and the ability to interact well with internal and external customers.
- Proficiency in MS Office, particularly the following applications: Word, Excel, Outlook, Teams, Access, Project, and PowerPoint. Adobe Acrobat Pro, Adobe Sign, Veeva Vault, and EXTEDO proficiency would be highly advantageous
JOB FUNCTIONS
- Daily issuing, archiving, and retrieving batch production records to support production and other department activities.
- Compilation, update, and/or amendment of internal documentation relating to the testing and manufacture of intermediates and/or APIs in accordance with the established Change Control Procedure.
- Implementation and withdrawal of production and quality documentation in accordance with established procedures.
- Responding to customers (both internal and external) and regulatory authority queries promptly and proactively.
- Providing the appropriate support to colleagues to ensure compliance with regulatory commitments.
- Independently formatting Word and PDF documents to ensure compliance with current regulatory requirements.
- Ensuring that all regulatory documentation is appropriately archived.
- Maintenance of documentation stored in the electronic document management system.
PERSONAL ATTRIBUTES
- Good interpersonal skills.
- Good organisational and systems implementation skills.
- Exceptional attention to detail and accuracy.
- Good communication (written and verbal).
- Ability to perform tasks concurrently.
- Self-motivated.
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Description
- Fine Chemicals requires the services of a highly competent Human Resources Manager. To qualify for this position suitable candidates must fulfill the following requirements:
Requirements
JOB REQUIREMENTS:
- Tertiary qualification in Human Resources Management/Industrial Psychology or relevant Behavioural Science.
- A minimum of 5 years HR generalist experience within a pharmaceutical /manufacturing and unionised environment.
- A minimum of 3 years in a Business Partner or Managerial role, preferably within a pharmaceutical or manufacturing environment
- Sound Employee and Industrial Relations experience
- Experience working with bargaining councils and trade unions would be advantageous
- Sound knowledge and experience of the application of the relevant Acts and regulations (LRA, BCEA, Skills Development, Employment Equity Act)
- SA Labour Legislation knowledge and understanding.
- Remuneration and Benefits experience.
- Diversity and Change Management.
- Proficiency in HRIS, SAP SuccessFactors, VIP Premier, and MS Office suite.
- Strong understanding of labour legislation, GMP/GLP, EE, BBBEE, and HR best practices.
BASIC JOB FUNCTIONS
- To plan, direct, and coordinate human resource management activities for FCC in order to maximise the strategic use of human resources and maintain functions such as Recruitment, Employee Relations, Employment Equity, Talent Management, Performance Management, Reward and Recognition, Change Management, and Regulatory Compliance in line with the business strategy.
- Develop and train staff, manage employee performance, timekeeping, recruitment of staff, and maintain staff discipline.
Financials:
- Management of business unit within parameters, including ensuring remuneration, benefits structures, annual increases, incentives, are in line with unit/group budgets and structures, and policies are executed according to legal and statutory requirements.
- Monitor head count and related costs.
- Monitor recruitment costs
Talent Acquisition:
- Drive and support recruitment activities within EE targets, business objectives, budget, and SOP.
- Manage the facilitation of staff movement.
Performance & Talent Management
- Collaborate with business to identify critical skills and current skills pool; and develop and implement succession plans to address current and future talent and development needs.
- Manage the Mid-Year and Final KPA reviews in line with Aspen/FCC policy and timelines.
- Manage the performance management process by ensuring consistent application.
- Coach the Line Manager in conducting KPA reviews. Check that departmental KPA's are S.M.A.R.T
- Facilitate all poor performance cases.
Corporate Culture:
- Execution of wellness, CSI, and transformation initiatives.
- Foster a culture and environment of inclusivity and employee well-being.
- Facilitate employee engagement initiatives and enhance employee experience.
- Communicate and educate line managers on HR policies and processes.
Employee Relations:
- Develop Structures and relationships that promote interdependence and reduce workplace conflict.
- Ensure that all FCC/Aspen policies and procedures are understood, implemented, and applied consistently.
- Monitor internal disciplinary processes by ensuring ongoing training, HR support, and correct implementation.
- Maintain effective correspondence with the Union/s in line with management consultations.
- Oversight role on CCMA and Labour Court Referrals
- Serve as a representative at CCMA, Labour Court, union negotiations, and related forums
HR Administration
- Ensuring that HR administration is always in an audit-ready state.
- Oversee accurate employee record keeping and system administration.
Health & Safety & GMP
- Carry out any duty or requirement imposed on the company by the OHS Act and in accordance with your specific SHE appointment.
- Ensure all sections within the department maintain compliance with company GMP standards.
PERSONAL ATTRIBUTES:
- Excellent planning and organising skills.
- Advisory skills.
- Good coaching, facilitation and presentation skills.
- Ability to interpret and implement policies, processes and objectives.
- The ability to navigate complex matters.
- Translate and execute HR strategy.
- Exercise interpersonal, communication, training, and problem-solving skills to optimise team performance
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Description
Overview
- Place and follows up on purchase orders and supplier payments
- Manage returns to suppliers
- Maintain positive working relationships with suppliers
- Keep records of all purchasing transactions carried out
Responsibilities
Strategic and ad-hoc ordering
- Contact suppliers and submit orders
- Direct informal negotiations, in case of ad hoc orders
- Conduct price checks
- Source products in line with business requirements within minimum lead times
- Ensure delivery of products in line with business requirements
- Check on missing/ rejected goods
- Communicate delays or quality issues to internal stakeholders to ensure inventory levels are maintained and risk to production is minimal
- Provide procurement input into supplier change notifications and new product introductions.
Supplier purchase and payment
- Oversee purchase approval process
- Generate purchase orders
- Manage the processing of invoices and effecting of payments
- Manage financial documents in accordance with financial controls (e.g. invoices and delivery notes are sent to finance to ensure payment takes place on time)
Returns
- Ensure all non-conforming materials are returned for credit and actions are put in place to prevent or reduce future quality issues
Reporting and record keeping
- Keep complete records for all purchase transactions
- Maintain filing and record keeping of all financial documents
- Ensure compliance with SOPs and organisation policies relating to Purchasing and Finance
- Provide detailed reports on work activities to supervisor, as required
Requirements
Skills Required
Background/experience
- At least 4 years’ relevant experience
- Experience in a Procurement environment in a highly regulated industry
- 2-year diploma in Logistics, or a related field
Specific job skills
- Computer literacy, including proficiency in the use of MS Excel and MS Word
Competencies
- Meeting Deadlines
- Capturing Facts
- Following Procedures
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OBJECTIVE OF ROLE
- To manage allocated territory sales activities to achieve sales targets and ensure adequate and equitable product supply in the region. Coordinate customer and market development activities to optimize on the sustainable volume demand and responsible use of the products.
KEY RESPONSIBILITIES
The successful candidate will be responsible for the following:
- Optimizing volume demand at Depo level through effective operational effort.
- Facilitate the supply of products into the territory through coordination of orders across health care facilities in the territory.
- Achieve and exceed monthly sales objectives as discussed and agreed with line manager.
- Establish strong business relationships with all key customers to maximize sales growth
- Ensure optimal territorial coverage in line with divisional needs
- Information gathering and dissemination / understanding and prescribing trends
- Regular updating of usage of major products
- Analyzing trends and changes, using facility data and reports from company BIS.
- Disseminate information on all new tenders to the respective facilities to plan and gather forecasting data.
- Track demand pattern and inform demand planning timeously.
- Initiate quotation business, secure stock and coordinate direct deliveries
- Support stock allocation efforts with CLOs and NSM on DDVs for stock in short supply.
- Coordinate customer tea room meetings, CMEs and conference in the region.
- Prepare and submit reports for various aspects of the business as per the instructions from the NSM.
- Prepare and present professional presentations to account on the performance and territory as and when required by management.
- Maintain and manage records connected to the company compliance policy.
- Maintain updated market databases.
- Establish contacts with industry leaders, policy-makers and influencers to provide value added solutions.
- Ensure customers have adequate stock holding of all products in line with provincial stock holding policies.
- All queries are followed up and resolved in shortest possible time within divisional policy framework
- Responsibility taken for credit returns, expired stock and damages at wholesalers.
- Ensure optimal stock levels at facilities and seek to maximize the ROI.
- Minimize and manage stock write off risk.
- Customer issues are dealt with according to customer needs.
Strategic Negotiations
- To achieve and exceed key sales objectives as discussed and agreed with line manager.
- Ensure that Depots are optimally stocked in line with their stock holding policy.
- Ensure that stock replenishment is done responsibly considering stock holding policy.
- Drive replenishment at DDV sites as well as at Depot Institutions through bottom up data management
- Ensuring all strategic engagements and negotiations become operationally visible through daily interaction and communication with territorial colleagues and management.
- Ensuring adherence to new legislations, the marketing code and Aspen’s values.
STOCK MANAGEMENT
- Review QlikView for stock levels and manage stock write off risk by offering short dated stock.
- Ensure that short dated stock gets offered first
- Manage customer stock queries by reviewing stock on QlikView/Power BI model
- Liaise with the CLO and NSM on stock queries and stock accepted by customers for releases.
- Manage product recalls within the company SOP.
Requirements
EDUCATIONAL REQUIREMENTS
- Matric / Grade 12
- B Com/Diploma in/ Certificate in – Marketing/Finance/Project Management/B Pharm, or any other relevant management qualification.
- Completed Inhouse sale/management training programme
KNOWLEDGE & EXPERIENCE REQUIREMENTS
- 1-2 years pharmaceutical or medical sales or business development experience within the public or private hospital environment is advantageous.
- Successful experience /understanding of the state tender business processes.
- Computer literate
- Presentation skills
- Decision making, commercially astute, self-driven, Teamwork, planning and organizing, project management, presentation skills, strategic thinking, leadership skills, analytical thinking, influencing, innovative, relationship savvy
- Knowledge of Business
- Knowledge of processes
- Recruitment and Selection
- Policy and procedure
- Finance knowledge
- System knowledge
- Product knowledge
- Industry knowledge
- Legislation and marketing code
SOFT SKILLS REQUIREMENTS
- Commercial acumen
- Project Management
- Analytical skills and ability to prepare presentation slides.
- Ability to mine information from company BIS
- Ability to perform under pressure and meet deadlines
- Verbal and written communication skills
- Aptitude for continuous learning
- Influential and impactful presentation skills
- Adaptability and flexibility in a changing environment
- Planning skills
- Time management
- Service orientation
- Interpersonal skills
- Communication skills
- Selling skills
- Team player
- Initiative
- Confidentiality
- Empathy
- Customer focused
- Interpersonal sensitivity
- Patience
- Influence
- Cultural sensitivity
- Attention to detail
- Logical thinking
- Information seeking
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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 multiple geographical locations & time zones
- Experience in medicine legislation and related guidelines, and codes of practice is 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 the 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 the 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 matrix 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 communication 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 ‘ccan–doattitude’
- 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 proactive approach to business tasks
- Business process analysis
- Report writing
- Information gathering and monitoring
- Projects (advantage)
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Description
JOB PURPOSE
- To take responsibility for and ensure efficient and effective secretarial and administrative support to the Deputy Company Secretary, Governance and Communications teams for maximum output in the delivery of quality business aligned services by the Company Secretariat and Governance Team, including facilitating and acting as an intermediary between the Company Secretariat / Governance Team and internal / external stakeholders including non-executive directors on all administrative and logistical matters. To undertake substantive company secretarial work including preparation of first drafts for the Deputy Company, documenting and taking responsibility for workflow of company secretarial matters generally through the electronic file management system (“FMS”). To take responsibility for and manage allocated matters from inception to resolution under supervision from the Deputy Company Secretary. Preparing and managing efficient and accurate reporting.
KEY PERFORMANCE AREAS
- Attend to various administrative duties as required, including processing of expense claims, stationery orders (board-specific and general), filing, etc.
- Assist the Deputy Company Secretary with secretarial and compliance-related duties including but not limited to statutory filing, maintenance of statutory records (electronic and hard copy), statutory/ secretarial queries, copy document requests, etc.
- Assist the Company Secretary and Deputy Company Secretary with administration requirements for the integrated reporting process, including maintaining the distribution database/ contact list and the distribution of reports.
- Efficient co-ordination of meeting rooms and MS Teams requirements for departmental meetings (internal and external), whilst maintaining the highest degree of confidentiality.
- Attend to the printing, binding and distribution of Aspen Board and Committee packs.
- Coordinate the requirements for all Board and Committee meetings, as well as arranging lunches, MS Teams meetings, etc.
- Collaborating with the Holdings Travel Desk to arrange travel (local and international) for non-executive directors.
- Processing of requisitions and purchase orders for all invoices for the Company Secretariat team and checking actual expenditure to budget.
- Ensure an efficient system is in place to record and track the process of requisitions (generate, submit for signature, ensure returned with signature and submit for payment).
- Handle all supplier/service provider queries and respond timeously, under the guidance of the Deputy Company Secretary.
- Attend to/ redirect company secretarial and communications queries appropriately, as and when necessary.
- Attend to any other team-related administrative tasks for the Company Secretariat as requested by the Company Secretary from time to time.
Requirements
EDUCATION:
- Matric / Grade 12 and recognized professional paralegal qualification, or university degree or sound progress towards a university degree, which is preferable
CERTIFICATIONS/REGISTRATIONS:
- National diploma Chartered Institute of Secretaries (CIS I / CIS II) or equivalent qualification an advantage
OVERALL EXPERIENCE:
- 3 to 5 years’ Legal Secretarial; Administrative and Coordination experience
SKILLS AND ATTRIBUTES:
- Verbal and written proficiency in English
- Effective administrative, project management and organisational skills
- Ability to juggle multiple tasks with accuracy
- Ability to communicate with senior level executives / directors (local & international)
- Diligent (or equivalent) platform administrator skills
- Essential to have expertise in Microsoft Office, particularly advanced MS Word including document security & protection, etc.; digital signatures, advanced Excel such as formatting, headings, filters, linking between sheets and workbooks, conversions, etc.; and advanced PowerPoint
- Electronic database establishment and management
- Ability to decide, action and assess priorities within area of responsibility, and when to execute Methodical implementation skills
- Co-ordination / monitoring of deliverables and trackers
- High attention to detail
- High levels of initiative and accountability
- Stakeholder focus and Outcomes-based
- Self-motivated
- Actions items allocated to completion
- High level of integrity, ethical values and confidentiality
Method of Application
Use the link(s) below to apply on company website.
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