Latest Jobs at Aspen Pharma Group

OBJECTIVE OF ROLE

• To support the SA Commercial Business to realize 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 Southern 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 through collaboration with internal customers to ensure delivery of accurate and scientifically balanced medical information and to respond to unsolicited inquiries from regulatory authorities, including clients and managed healthcare organizations in a manner that will help them make a decision regarding therapy for a patient or product selection.

KEY RESPONSIBILITIES

 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

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.

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.

MAINTENANCE OF THE ASPEN MEDICALLY CRITICAL LIST

• Initiating and finalizing 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:SC procedures where there are shared responsibilities.

PROJECT MANAGEMENT

• Providing assistance with any specific projects and operational support for the Medical Information and Compliance team. 

FINANCIAL 

• Effective utilization of resources to keep processes cost effective.
• Adherence to Regulatory Affairs budget and forecasts.

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).
• Support 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 staff.
• Any other duties as assigned by Manager.

Requirements

EDUCATIONAL REQUIREMENTS

• 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

KNOWLEDGE & EXPERIENCE REQUIREMENTS

• 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

SOFT SKILLS AND COMPETENCY REQUIREMENTS

• Integrity and good work ethic
• Ability to work under pressure to meet deadlines
• Flexibility
• Analytical and planning skills
• Accuracy and attention to detail
• Effective organisational skills and ability to prioritise
• 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
• Presentation skills
• Time management skills
• Decision making and logical thinking skills
• Customer focused
• Excellent interpersonal and communications skills
• Enthusiasm and drive to take ownership and drive process initiatives
• Information gathering and report writing

go to method of application »

OBJECTIVE OF ROLE

• To support the SA Commercial Business to realize 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.
• The role undertakes responsibility for compliance with the Regulatory / Pharmacovigilance 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.

KEY RESPONSIBILITIES

FINANCIAL

• Project management of contractual and financial aspects of all medical writing projects and the effective utilization of resources to keep processes cost effective.
• Identification of project challenges to be shared with the 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 Manager 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, Dear 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.

Requirements
EDUCATIONAL REQUIREMENTS

• Matric
• B.Sc. (Hons) or equivalent scientific qualification (B.Pharm is preferable)

KNOWLEDGE & EXPERIENCE REQUIREMENTS

• 4yrs experience in pharmaceutical clinical research expertise.
• 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

SOFT SKILLS AND COMPETENCY REQUIREMENTS

• Results and performance driven – deliver results that meet or exceed expectations
• Integrity with a robust work ethic
• Deadline driven
• Sense of urgency – responding to issues and opportunities in a timely manner
• Intellectual curiosity – willing to suggest and try new ideas
• Positive and proactive 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.