Latest Opportunities at Aspen Pharma Group

MAIN DUTIES:

• Tender Contract Price Adjustment Oversight.
• Tender Preparation Activities.
• Customer Service Performance Reporting
• Debtor’s Query Validation
• Administrative Sales Support

Outputs

• Monthly tracking and submission of tender contract price adjustments.
• Oversight on the tender preparation platform and data integrity of the platform.
• Completion of tender specific qualitative and quantitative details on NDoH documentation.
• Proactive engagement with internal/external stakeholders to ensure compliance with all NDoH/National Treasury requirements.
• Validation invoice short-payments and customer payment queries received from finance team.
• Review of data capture accuracy for the customer service team and monthly report compilation to ensure customer service deliverables are met.
• Monthly review of customer service team queries related to 3rd party stakeholders.
• Periodic assistance with order capture (sales support).

QUALIFICATION AND EXPERIENCE:

• Matric
• Degree in Finance / Economics related fields.
• Project Administration experience.
• Computer literate (Microsoft Excel and Word).
• Prior exposure to Public Health Business operations. 
• Exposure to SAP.

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JOB REQUIREMENTS:

• Degree in Chemistry/Pharmaceutical Sciences or equivalent qualification.
• Good knowledge of chemistry (Analytical and Organic).  Knowledge of local and international pharmaceutical regulations and guidelines would be highly advantageous.
• Excellent written and verbal communication skills and the ability to interact well with internal and external customers.
• Minimum of 3 years’ experience in the pharmaceutical, cGMP, or chemical manufacturing environment.
• Proven technical documentation compilation skills, with the ability to critically evaluate and interpret data.
• MS Office computer literacy, particularly the following applications: Word, Excel, Outlook, Teams, Access, and PowerPoint.  Minitab and/or EXTEDO proficiency would be advantageous.

JOB FUNCTIONS (Brief Summary)

• Compilation and update of documents to be submitted to Regulatory Authorities.  This includes the compilation of Common Technical Documents (CTDs) in accordance with relevant guidelines and regional requirements.
• Compilation, update, and/or amendment of internal documentation relating to the testing and manufacture of Active Pharmaceutical Ingredients (APIs).
• Responding to customer (both internal and external) and regulatory authority queries.
• Ensuring that annual product quality reviews are compiled according to cGMP standards and adverse trends and potential process improvements identified.
• Implementing changes according to established company procedures relating to the testing and manufacturing process.
• Compilation and/or update of manufacturing and cleaning instructions according to internal procedures and in line with regulatory expectations.
• Compilation of process qualification protocols and reports.
• Ensuring that related databases are updated to allow for the capturing of API data. 

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MAIN DUTIES:

The successful candidate will be responsible for the following:

• Working with Key Account Managers in optimizing volume demand at DepotSub-Depot/DDV/Demander 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 stock systems 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 stock systems
• Liaise with the KAM,CLO and NSM on stock queries and stock accepted by customers for releases.
• Manage product recalls within the company SOP.

QUALIFICATIONS & EXPERIENCE:

• Matric / Grade 12
• National Diploma in Marketing/Public Relations/Humanities etc. or B Com – Marketing/Finance and/or B Pharm, and/or BSc Medical qualification essential
• Post graduate qualification in Marketing would be an added advantage
• 1-2 years of pharmaceutical sales/customer services/business development experience within the public or private hospital environment is advantageous
• Demonstrated experience /understanding of the state tender business processes
• Computer literate
• Presentation skills
• Decision making, commercial astute, self-driven, Teamwork, planning and organizing, project management, presentation skills, strategic thinking, leadership skills, analytical thinking, influencing, innovation, relationship savvy.

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KEY RESPONSIBILITIES

Strategic Decision making

• Develop promotional and advertising strategies that grow brand market shares against competitors in all channels (Doctor, Pharmacy, Wholesale & Retail)
• Strategies need to create demand for Brands in portfolio’s by ensuring the necessary support to the sales teams with high levels of energy, motivation, integrity, and urgency to help them achieve sales targets.
• Market analysis and gathering insights to arrive at strategic intent.
• Develop succinct portfolio/brand strategies with supporting tactical plans in form of a Brand Plan to drive the strategic intent.
• Successful roll out and lead the implementation of tactical plans and monitor the roll out.
• Implementation, monitoring, and measurement of the success of the developed strategies and to ensure that they are flexible to adapt to a dynamic environment.
• Anticipate future trends in disease management and the market environment. 

Commercial capability

• Ability to set sales budgets agreed in the business.
• Managing advertising budget and spend for the portfolio.
• Ability to manage the cross functional networks and channel resources for the portfolio to drive profitable growth.
• Ability to interpret and implement insights drawn from a variety of internal and external data sources.

Sustainable business growth and profitability

• Forecasting accuracy and stock management which entails minimizing write-off costs and returns, monitoring and managing distributor and wholesaler’s stock holding as well as backorders.
• Effectively manage and monitor sales as well as promotional budgets
• Effectively manage and initiate the required Advertising and promotional campaigns to support execution excellence and maximize ROI.
• Effectively manage and initiate the required Advertising and promotional campaigns to support execution excellence and maximize ROI.
• Initiate robust measurements for tactical execution outcomes to maximize ROI and future commitment decision making.
• Assess market potential of opportunities/pipeline with NPL team to successfully implement new products once launch ready.
• Pipeline management to secure future portfolio assets with NPL team.

Innovation

• Innovative way of thinking to secure a competitive advantage.
• Solution orientated Provide creative direction for brand/ portfolios strategies.

Internal and external customer interaction

• Enthusiastically communicate plans and results with the Sales force, business leadership and relevant teams within the business regularly
• Drive cross functional efficiencies and collaboration with key stakeholders to deliver on quantitative and qualitative targets and achieve brand/portfolio priorities through engagements.
• Sense of urgency in resolution of customer queries
• Quality assessments of portfolio/ brand strategy and tactical implementation through customer interactions / infield visits to obtain required intelligence and insights.
• Optimize Training department engagements to ensure field force is fully equipped and aligned with strategic and execution requirements.

SKILLS AND ATTRIBUTES

• Enthusiasm, passion, high energy are key requisites
• Commercial acumen
• Analytical skills
• Project management
• Networking ability
• Interpersonal skills
• Ability to perform under pressure
• Self-starter and self -motivated
• Sense of urgency
• Prioritizing and planning
• Verbal and written communication skills
• Aptitude for continuous learning
• Influential and impactful presentation skills
• Adaptability and flexibility in a changing environment 

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MAIN DUTIES:

Strategy Delivery

• Develop and Implement demand management and inventory holding strategy with Business unit head 
• Contribute to Marketing strategy sessions and translate outcome into future planning actions

Monthly IBP Cycle

• Implementation of IBP in accordance with latest business requirements 
• Facilitate monthly demand reviews
• Consolidate and ensure sound understanding of Volume, Value & Assumption movement 
• Consolidate and quantify future Opportunity & Risks
• Drive Gap closing actions and drive decision making on key demand drivers impacting future forecasts 
• Drive demand shaping actions/decisions using existing excess inventories
• Responsible for coordination & total aggregation of Demand Review for the respective portfolio

Monthly Operations – Statistical/Baseline Forecasting 

• Ensure historical data is relevant and reviewed to enable the use of statistical forecasting 
• Manage market demand through monthly forecasting meetings in collaboration with Marketing
• Drive the use of statistical forecasting to derive baseline demand
• Make adjustments to statistical forecasts based on market intelligence and insights on future drivers of demand

Monthly Operations – Consensus Forecasting 

• Continuously collaborate with Marketing to ensure forecasts are based on sound assumptions
• Engage with Marketing & Sales to unpack risks and opportunities and gap closing initiatives
• Collaborate with Marketing & Sales to unpack latest demand drivers and events and agreed on necessary changes in forecast & assumptions
• Conduct necessary analytics where required to support decision making on forecast

Monthly Operations – Replenishment Forecast

• Lead a monthly review of the supply plan highlighting supply risks and potential excess stock risks
• Drive effective communication with suppliers to mitigate the supply and excess stock risks
• Collaborate with Marketing and Supply to optimize stock holding to achieve service and inventory objectives
• Facilitate aggregation of total SKU level replenishment requirement for SKU’s crossing State & Export

Continuous Improvement 

• Track sales vs actual to unpack latest demand movements. Drive improvement in forecast accuracy by understanding reasons for deviations from forecasts driving remediation plans
• Explore & Adopt various forecast methodologies to improve forecast accuracy
• Proactively drive planning excellence through people, process and tool and process streamlining
• Implement and drive SKU segmentation to allow business product prioritization
• Work in collaboration with Supply and finance to adjust stock policies and planning parameters to optimise inventory holding
• Support planning-related project implementation

Other Planning Team Activities

• Ensure item master data integrity is maintained for all portfolios
• Liaising and building relationships with sites and commercial BU Heads
• Build and develop a high-performance team through active coaching and clearly defined development plans 
• Support Demand & Supply manager with strategic and operational needs

EDUCATION & EXPERIENCE: 

• Bsc Engineering, Bcom Finance, Bcom Supply Chain relevant categories
• Planning experience 8+ years with Demand Management experience 5+ years
• Team management experience 5+ years
• Planning experience in FMCG or Pharmaceutical experience a must
• Import/Export and Supply Chain knowledge a must 
• Statistical & Consensus Forecasting experience 
• Supply Planning understanding a must 
• Understanding of ERP systems and strong MS office working knowledge
• Preferable experience: Working knowledge of Qlikview, Power BI and SAP

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KEY PERFORMANCE AREAS

• Prioritises areas for quality improvement by considering the strategy, wider business objectives and results from internal and external audits.
• Initiates the application of appropriate quality management techniques in these areas.
• Initiates improvements to processes by changing approaches and working practices, typically using recognised models. 
• Achieves and maintains compliance against national and international standards, as appropriate.
• Identifies and plans systematic corrective action to reduce errors and improve the quality of the systems and services, by examination of the root causes of problems.
• Leads, develops and is accountable for an organisational approach and commitment to quality assurance. 
• Ensures that quality assurance processes and activities are robust and based on industry best practice.
• Considers the implications of emerging technology, approaches, trends, regulations and legislation. 
• Plans and resources the organisational quality assurance activities.
• Monitors and reports on quality assurance activities, levels of compliance and both organisational and project risks.
• Reviews and analyses results from audit activities and identifies improvement opportunities for the organisation.
• Plans, organises and conducts formal independent audits of complex projects, major programmes or functional areas. 
• Evaluates, appraises and identifies non-compliances with organisational standards, and determines whether appropriate quality control has been applied. 
• Prepares and reports audit findings and determines the risks associated with those findings and ensures that corrective actions are carried out. 
• Reviews and analyses audit reports to identify common areas of non-compliance and identifies opportunities to improve the effectiveness and efficiency of the organisational control mechanisms. 
• Performs audits throughout the supply chain. Plans and oversees the assurance activities of others.
• Advises on the application of appropriate quality management techniques and standards. 
• Ensures that projects, teams and functions have appropriate practices in place and are meeting required organisational quality levels. 
• Determines areas where existing processes should change from analysing audit findings.
• Takes responsibility for controlling updating and distributing organisational standards. Facilitates improvements to processes by changing approaches and working practices, typically using recognised models.

JOB REQUIREMENTS

EDUCATIONAL QUALIFICATIONS & EXPERIENCE:

• Matric / Grade 12
• B.Com / BSc Computer Science degree or equivalent work experience 

CERTIFICATIONS/REGISTRATIONS:

• Current industry certification in architecture and quality (i.e., TOGAF, GxP, ISO 9000)
• Business Process Management Methodology (i.e., BPM, SDLC, ITIL, DevOps, Agile, COBIT)

OVERALL EXPERIENCE:

• 10+ years’ experience of managing relationships with internal business customers

SPECIFIC EXPERIENCE, KNOWLEDGE AND REGISTRATIONS:

• Experience and sound knowledge of Business processes, quality management and auditing and assurance practices and improvement practices
• 10+ years’ experience managing customer relationships in an operational and global services and automation in a large complex/matrix global organisation

WORK-SPECIFIC SKILLS & EXPOSURE:

• 10+ years’ experience leading and influencing customers and matching needs to solutions

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KEY RESPONSIBILITIES

Key Accountabilities

• Delegated tasks from RA Manager or PV Lead on a defined and ad hoc basis with the flexibility of mind-set and time resource this entails. This will include representation at meetings when required.
• Functional reporting: Mentoring of the Pharmacovigilance Officers and Medical Writers.
• Review and advice regarding relevant local and global guidelines, policies, internal procedures and SOPs across Aspen Pharmacare.
• Maintain awareness of Pharmacovigilance regulatory requirements and developments.
• Manage outsourced data collection, organisation and preparation with vendors. 
• Act as Subject Matter Expert (SME) in designated area (e.g. literature, signal management, aggregate reports, labelling etc.) responsible for oversight and coordination of tasks related to the area of expertise.
• Preparation of annual as well as ad-hoc and scheduled aggregate safety reports.
• Ensure Good Documentation Practice.
• Contribute to agreed PV Team quality and compliance targets.
• Serve in a leadership capacity for complex and strategically important Pharmacovigilance developmental programs.
• Direct interaction with Regulatory Authorities.

Financial

• Identification of project challenges to departmental line management and the financial impact thereof.
• Project management of contractual and financial aspects of all medical writing projects and the effective utilisation of resources to keep processes cost effective.

Medical Writing Accountabilities

• Work in collaboration with Medical Writers to write clinical documents for submission to regulatory authorities, including but not limited to:
• clinical overviews and summaries
• integrated summaries of safety and efficacy
• Clinical Expert Statements
• Provide medical editing review of draft and final documents prepared by other team members before internal or external distribution. This includes both copy editing and content review.
• Ensure document content and style adheres to SAHPRA/FDA/EMA or other appropriate regulatory guidelines and complies with Aspen SOPs and style guidelines
• Perform literature searches/reviews as necessary to obtain background information and training for development of documents.

Safety

• ICSR (Individual Case Safety Reports)
• Ensure all cases are processed, medical reviews completed, and cases submitted to Health Authorities as per the timelines specified in the guidelines.
• Ensure quality checks are performed on weekly, monthly, quarterly and bi-annual reconciliations with internal and external stakeholders.
• Labelling
• Updating and reviewing Product Information in line with the Company Core Data Sheets, and other tasks as designated.
• Aggregate Reporting
• Preparation of aggregate safety reports including but not limited to PSURs, PBRERs and Addendum Safety Reports.
• Risk Management System
• Preparation of Risk Management Systems including but not limited to Risk Management Plans and Risk Communication Plans.
• Request for Information (RFI) from Competent Regulatory Authority (CRA) and Safety Communication (Dear Healthcare Professional Letter (DHCPL)
• Manage safety related requests from regulatory agencies and Aspen Affiliates to ensure any requests are answered fully and promptly.
• Literature Reviews
• Monitor local literature for designated products and identify safety issues/ ICSRs in a timely manner.
• Signal detection
• Coordinate and prepare appropriately for signal management meetings.
• Signal Management Activities including compilation of Signal Assessment Reports/ Case 
• Series Reviews for potential signals.
• Safety Data Exchange Agreements (SDEAs)
• Creation and update of Safety Data Exchange Agreements (SDEAs).

Training

• Oversee training and mentoring of other Pharmacovigilance staff, and prepare training materials 
• Lead initiatives to develop, implement and conduct appropriate training in all aspects of Pharmacovigilance Safety activities
• Maintain a high and up-to-date level of product and therapy area knowledge by attending conference, training courses, reading relevant medical and scientific literature

QMS

• Ensure systems and procedures are in place in accordance with the RA QMS and that these are maintained according to the relevant SOPs
• Creation and update of SOPs/WIs for all pharmacovigilance activities related to the job role in line with Pharmacovigilance regulations/guidelines (EU, ZA and other territories applicable), within specified/SOP timelines.

General

• Adhere to agreed Key Performance Indicators (KPIs)
• Support the continuous development and improvement of the PV function while upholding Aspen core values
• Effective management and utilisation of resources to keep processes cost effective
• Collating data for ad hoc requests
• Adherence to Company Health & Safety procedures
• Participate in training programmes
• Any other duties as assigned by your Manager

SKILLS AND ATTRIBUTES

• Results and performance driven – deliver results that meet or exceed expectations
• Integrity
• Work ethic
• Ability to meet deadlines
• Sense of urgency – responding to issues and opportunities in a timely manner
• Intellectual curiosity – willing to suggest and try new ideas
• Positive and pro-active approach to business tasks
• 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
• Service orientation
• Customer focused
• Logical thinking
• Information seeking
• Positive ‘can – do’ attitude
• Be able to work autonomously and have good problem-solving skills
• Able to cope with evolving deadlines effectively with regular feedback and updates
• Honest and trustworthy
• Respectful and highly personable
• Possess cultural awareness and sensitivity
• Flexibility & confidentiality are key requirements for this role.

KNOWLEDGE

• Strong knowledge of regulatory and medical authorities in South Africa
• Strong understanding of regulations, ICH guidelines, and GCP
• Extensive medical writing and expertise in submission

EDUCATION & EXPERIENCE

• Matric
• Biological/life Sciences Degree or equivalent
• B. Pharm would be advantageous.
• Documented experience in all aspects of pharmacovigilance is an inherent requirement and not negotiable.
• 3-5 yrs. pharmaceutical experience with specific focus areas in PV/Drug Safety
• Experience working with safety databases.
• Experience writing large safety reports e.g., DSURs, PADERs, PSURs, PRBRERs is preferable.
• Experience in writing RMPs is desirable.
• Experience working with MedDRA coding dictionary.

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MAIN DUTIES:

FINANCIAL

•  Effective utilization of resources to keep procedures cost effective.

CUSTOMER

• Display a professional attitude when responding to customers.
• Propose, develop, and update methods to improve customer services.
• Effective liaison and communication with internal and external customers, including but not limited to Regulatory Authorities, External consultants and Agents, Quality Assurance, Project managers, Artwork, New Product Launches, Manufacturing Sites, Pharmacovigilance, Medical Information and Compliance, AGI, APTL,

QUALITY MANAGEMENT

• Ensure systems and procedures are in place in accordance with the RA QMS and that these are maintained according to the relevant SOP’s.

DUE DILIGENCE

• Perform due diligence on new IP identified for licensing/acquisition to identify deficiencies in the IP relating to SAHPRA and SADC member states laws and regulations, in compliance with timelines in licensor/purchaser agreements.
• Raise all risks and critical issues with line manager at DD stage before issuing DD report.
• Request CCDS/PI, frills, samples, etc. from the relevant departments as per process, within specified timelines.
• Follow up with stakeholders on DD requests until finalization of outstanding matters, ensuring a quality and compliant submission

NEW REGISTRATION APPLICATIONS

• Use Veeva RIM and dedicated secure drive to compile quality dossiers which are compliant with country specific requirements, guidelines, regulations, and internal departmental procedures, within the allocated timelines, ensuring smooth progression to Marketing Authorisation.
• Raise any minor additional data requirements identified at compilation stage so as not to compromise proposed submission date.
• Ensure required fee is paid to the Authority.
• Ensure relevant support personnel are asked timeously to prepare the submission, over-see and review such activities.
• Ensure proof of receipt from relevant Authority is received and recorded.
• Update and maintain all appropriate trackers, databases and systems as required to ensure visibility and accurate reporting.
• Attend to action items in the eQMS to ensure compliance with completion/closeout timelines.

RESPONSE TO SCREENING OUTCOMES AND RECOMMENDATIONS

• Compile and submit compliant responses to screening outcomes from regulatory authorities by requesting additional data/frills/samples.
• Over-see completion of administrative functions as per departmental procedures.
• Compile and submit compliant responses to recommendations from the Authority Units (including renewals), being aware of communicating risks to line manager.
• Action and close out eQMS items

REGISTRATION

• Ensure new Marketing Authorisations are up to date with all pre-registration activities, including recommendations from all relevant Authority committees or units.
• Ensure that all labelling components are updated with the registration details as per departmental procedures.
• Ensure that translated labelling text is available if required as per country specific requirements.
• Ensure that accurate labelling text is provided to the Artwork Department via the Pulse system, for implementation in the market.
• Consider impact of registration details on shared packs.
• Receive and review registration certificate for errors and arrange correction.
• Check for post-registration variations and notify line manager of these as per process.
• Action and close out eQMS items
• Over-see completion of administrative functions as per departmental procedures.

DOSSIER MAINTENANCE (VARIATIONS)

• Submit Variations to regulatory authorities in accordance with laws and regulation.
• Ensure required fee is paid to the Authority.
• Receive and distribute approval documentation from regulatory authorities as per departmental procedures.
• Update and maintain all relevant trackers, databases and systems.
• Action and close-out eQMS items.
• Over-see completion of administrative functions as per departmental procedures.

PROJECTS

• Coordinate and manage projects as required.

TRAINING

• Provide technical and procedural training to the department in line with development needs
• Provide one on one training and coaching to less experienced staff and reviewing their work as required.

QUALIFICATION AND EXPERIENCE:

• Matric
• Bachelor of Pharmacy degree or equivalent
• Registered with the South African Pharmacy Council as a practicing Pharmacist.
• 1 to 2 years’ experience within the Pharmaceutical Industry in a Production/Quality/Clinical environment.
• Minimum 2 years’ experience in a Regulatory Affairs environment, including compilation and submission of variations and new products in accordance with the latest regulatory authority requirements.

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MAIN DUTIES

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.
• Ensuring that Affiliate/Distributor/MI is adhering with 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 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 PI 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.

EDUCATION & EXPERIENCE:

• Matric
• Bachelor of Pharmacy Degree and registration with the South African Pharmacy Council
• Multilingualism (including Afrikaans) would be an advantage
• Minimum 1 to 2 years’ pharmaceutical experience
• Experience in Medical Information is an advantage
• Effective use of appropriate IT systems and programs
• Ability to work with multi geographical locations & time zones
• Experience in medicine legislation and related guidelines and codes of practice preferable

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MAIN DUTIES

FINANCIAL

• Project management of contractual and financial aspects of all medical writing projects and the effective utilisation of resources to keep processes cost effective.
• Identification of project challenges to departmental line management and the financial impact thereof.

PROJECT MANAGEMENT

• Act in the capacity of project manager/lead for medical writing projects. This may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues, and other duties as assigned.
• Project management of contractual and financial aspects to be performed with management where necessary.
• Serve as the Medical Writing representative to provide proactive support for planning efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Identify any potential project challenges to departmental line management and project leader, including changes in project plan, timeline or out of scope requests, and suggest possible resolution options.
• Coordinate and conduct interdepartmental team review and sign-off of document deliverables according to Pharmacare guidelines/SOPs.
• Coordinate production and distribution of draft and final documents to regulatory teams. Ensure that all work is complete and of high quality prior to team distribution.
• Attend internal and technical team meetings as required.
• Assist management as needed with preparation of resourcing estimates for potential new medical writing projects
• Proactively engage with other departmental resources where necessary to ensure that information/documentation requests are delivered in a professional and timeous manner.

MEDICAL WRITING ACCOUNTABILITIES

• Ensure defined framework as set by PV Lead, RA Manager: Safety, Quality and Compliance, or Head of Department are executed within the specified timelines.
• Write clinical documents for submission to regulatory authorities, including but not limited to:
• clinical overviews and summaries
• clinical expert statements
• interim and final clinical study reports
• integrated summaries of safety and efficacy
• nonclinical overviews and summaries
• Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.
• Ensure document content and style adheres to FDA/EMA/SAHPRA or other appropriate regulatory guidelines, and complies with departmental and corporate SOPs and style guidelines
• Perform literature searches/reviews to obtain background information and training for development of documents
• Prepare country specific packs for submission of safety variations within ZA and other territories 
• Assist in the assessment of clinical and nonclinical documentation with regards to its suitability for supporting new marketing authorisation applications (MAA) or new indications.

SAFETY

• Aggregate reporting
• Preparation of aggregate safety reports including but not limited to PSURs, PBRERs and Addendum Safety Reports.
• Risk Management System
• Preparation of Risk Management Systems including but not limited to Risk Management Plans, Healthcare Professional Letters and Risk Communication Plans.
• Request for Information from Competent Regulatory Authorities (CRAs)
• Manage safety related requests from regulatory agencies and Aspen Affiliates to ensure any requests are answered fully and promptly.
• Signal Management
• Assessment of local PI/PIL for inclusion of the validated signal.
• Data analysis of signals and feedback to the Safety Review Team (SRT) during the Signal Management meetings.

TRAINING

• Provide training and guidance and act as a mentor to less experienced departmental members.
• Initiate and participate in departmental or interdepartmental process improvement and training initiatives.
• Initiate and manage development of formats, templates and general guidelines for clinical documentation and workflow procedures.
• Assist in the development of departmental SOPs/WIs.
• Keep abreast of professional information and technology through workshops and conferences and ensure the appropriate transfer of that information to the department. 

GENERAL

• Ensure systems and procedures are in place in accordance with the RA QMS and that these are maintained according to the relevant SOPs
• Adhere to agreed Key Performance Indicators (KPIs).
• Support the continuous development and improvement of the PV function while upholding Aspen core values.
• Maintain rigorous adherence to written procedures, e.g. SOPs/WIs.    
• Adherence to Company Health & Safety procedures.
• Participate in training programmes.
• Any other duties as assigned by your Manager.

KNOWLEDGE:

• Strong knowledge of regulatory and medical authorities in South Africa
• Strong understanding of regulations, ICH guidelines, and GCP
• Extensive medical writing and expertise in submission

EDUCATION & EXPERIENCE: 

• Matric/ Grade 12
• B.Pharm (preferred); B.Sc. (Hons) or equivalent scientific or clinical qualification
• 4yrs experience in pharmaceutical industry (clinical expertise)