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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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MAIN DUTIES
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 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 contento 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 authorization 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.
Requirements
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
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.
EDUCATION & EXPERIENCE:
- Matric/ Grade 12
- Pharm (preferred); B.Sc. (Hons) or equivalent scientific or clinical qualification
- 4yrs experience in pharmaceutical industry (clinical expertise).
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ROLE PURPOSE:
Strategic and tactical role in the digital technology organisation and is accountable for the provision of support and guidance on portfolio, programme and project management processes, procedures, tools and techniques. Support includes definition of portfolios, programmes, and projects; advice on the development, production and maintenance of business cases; time, resource, cost and exception plans, and the use of related software tools. Tracking and reporting of programme/project progress and performance are also covered, as is the capability to facilitate all aspects of portfolio/ programme/ project meetings, workshops and documentation. The role is accountable for establishing an approach for forecasting, planning and monitoring the emergence and effective realisation of anticipated benefits. Identifying and implementing the actions needed to optimise the business impact of individual and combined benefits. The confirmation of the achievement of expected benefits.
KEY PERFORMANCE AREAS:
- Defines the approach/policy and sets standards for the support provided for managing and monitoring portfolios, programmes, and projects.
- The governance/management of resources, directing and leading the implementation and on-going operation of an effective service organisation, ensuring delivery of effective services/resources in line with current and planned demand and reviewing the effective provision.
- Takes responsibility for the provision of portfolio, programme and project support.
- Advises on the available standards, procedures, methods, tools and techniques.
- Evaluates project and/or programme performance and recommends changes where necessary.
- Contributes to reviews and audits of project and programme management to ensure conformance to standards.
- Promotes the change programme vision to staff at all levels of the business operation, brings order to complex situations, and keeps a focus on business objectives.
- Works with other capability managers to ensure maximum improvements are made in the business operations as groups of projects deliver their products into operational use.
- Maintains the business case for funding the programme and confirms continuing business viability of the programme at regular intervals.Identifies specific measures and mechanisms by which benefits can be measured and plans to activate these mechanisms at the required time.
- Monitors benefits against what was predicted in the business case and ensures that all participants are informed and involved throughout the change programme and fully prepared to exploit the new operational business environment once it is in place.
- Supports capability managers to ensure that all plans, work packages and deliverables are aligned to the expected benefits and leads activities required in the realisation of the benefits of each part of the change programme.
EDUCATION QUALIFICATION & EXPERIENCE:
- Matric / Grade 12
- B.Com / BSc Computer Science /similar degree or equivalent work experience
- Solution and Operational Management Methodology PMP, PRINCE2, PMBOK, PfMP, MoP, PPMC,
- 10+ years’ experience of managing relationships with internal business customers
- Experience and sound knowledge of portfolio, program and project management, implementation and improvement practices
- 10+ years’ experience managing portfolio, programs and projects in a large complex/matrix global organisation
- 10+ years’ experience leading teams, internal and 3rd parties in a multivendor approach
SKILLS AND ATTRIBUTES:
- Innovation
- Visioning
- Strategic planning
- Global thinking
- Entrepreneurial thinking
- Teamwork
- Initiative
- Results oriented
- Systems thinking
- Focused
- Problem-solving and good judgment
- Responsibility and accountability
- Cooperation
- Proactive
- Resilience
- Active listening skills
- Presentation skills
- Meeting facilitation
- Organisational awareness
- Influence skills
- Pragmatic
- Empathy
KNOWLEDGE:
- Technical / professional knowledge
- Industry knowledge
ASPEN COMPETENCIES:
Business
- Create the Future
- Accountability/ Ownership
People
- Communicate Effectively
- Dealing with ambiguity Embrace Change
Self
- Contribute Special Expertise
- Take Action with Integrity
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Overview
- Implement after-market compliance systems and quality procedures, standards, and specifications
- Identify and provide solutions to systematic issues
- Create and review APQRs and PQRs
- Deal with complaints, recalls and CAPAs
Responsibilities
Process improvement and support
- Initiate, coordinate, perform and follow up on internal audits
- Provide support during external GMP audits by regulatory and other bodies and perform audit follow-up
- Review validation protocols and reports
- Review GMP-relevant technical/ engineering documentation
- Review and approve event handling and change control
- Compile and maintain SOPs
- Review and sign off change requests and validation documents APQRs and PQRs
- Perform
APQR and PQR processes/ systems
- Review compiled APQRs and PQRs
- Compile APQRs and PQRs if necessary
- Provide input into product reviews as required by health authorities
- Engage with relevant departments to address recommendations and outstanding information
Complaint resolution
- Handle customer complaints, queries and adverse drug reactions and related investigations
- Conduct complaint intake, triage and investigation
- Handle returns and recalls, as required
- Interact with health authorities, where required
Correction and prevention
- Initiate CAPAs and follow up with relevant departments related to Events, Audits, Self-inspections,
- Complaints and PQRs
- Review and approve event handling and change control
Reporting and analysis
- Categorise complaints, conduct trend analyses and report
- Conduct root cause analysis and risk assessment and report
Planning and operational support
- Provide technical and operational input during drafting of plans and procedures specific to unit
- Request, allocate and monitor the use of assets and resources for the fulfilment of work objectives
- Stay up to date on developments, trends, legislation and regulations
- Provide information for reports, as required by superior
Requirements
Background/experience
- Bachelor’s degree (B Pharm) with 4-6 years’ related work experience, or Post Graduate Degree/ Diploma with 2-4 years’ related work experience
- Pharmaceutical manufacturing experience
Specific job skills
- Protocol and technical report writing skills
- Good knowledge of local registrations and regulations and of international regulations/guidelines
concerning GDP/GMP, QA
- Advanced understanding of the pharmaceutical manufacturing and corrective action programs
- Pharmaceutical standards and compliance requirements
- Ability to interpret and implement policies, processes and objectives
Competencies
- Information Gathering
- Interrogating Information
- Managing Performance
- Offering Insights
- Endorsing Quality Standards
Accountability & Decision Rights
- Demonstrate initiative and apply advanced concepts
- Exercise interpersonal, communication, training and problem-solving skills to optimise team performance
- Integrate resources for an area
- Escalate highly complex problems or out-of-policy issues
Independent decisions relating to:
- Technical approach for project components, often in ambiguous situations, requiring advanced analytical skill, training and/ or education
- Establishing own work priorities and timelines
- Interpretation of policies, standards, requirements and approaches
Closing Date: 4th,July 2022
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Overview
- Perform QC and stability tests on raw materials, in-process and finished products, components and water to ensure quality and compliance
- Review compliance of products to GMP, quality standards, and product specifications
- Provide services according to Production plan
Requirements:
Planning and Operational Support
- Optimise and facilitate implementation of current processes
- Propose changes or improvements to processes, tools and techniques
Test Preparation
- Prepare and analyse samples according to SOP’s
- Prepare and operate laboratory equipment according to SOPs
- Perform calibration checks on equipment according to calibration procedure, to ensure accurate results
- Prepare reagents and solutions for testing
- Maintain good housekeeping
Testing
- Perform routine analysis on in-process and final products, raw materials and components
- Perform routine stability tests such as related substances, assay and dissolution to assess quality of product
- Perform routine stability tests such as related substances, assay and dissolution to assess quality of product
- Perform daily and weekly water testing according to SOP
- Support testing for OOS investigations to establish any systematic issues in process or testing
- Handle problems efficiently according to quality policy
- Report feedback on services or outputs regularly to customers
- Check HPLC/GC runs regularly during the shift
- Provide internal customers with accurate HPLC/GC results
- Propose, develop and update methods for improving customer service
- Check, document and report operational output against actuals
- Communicate deviations for production and process improvements
- Utilise technology as per qualification requirements
Reporting and Record-Keeping
- Document and store data according to SOPs and regulation
- Consolidate information for reports on weekly/ monthly
- Analyse consolidated data and provide recommendations
- Record, interpret and report testing results to management, including OOS results
Skills required
Background/experience
- National Diploma in Analytical Chemistry with 2+ years experience
Specific job skills
- Advanced understanding of pharmaceutical testing methods
- Understanding of pharmaceutical manufacturing and corrective action programs
- Knowledge of Millennium Software (HPLC) and GC Software
- Pharmaceutical standards and compliance requirements
- Ability to interpret and implement policies, processes and objectives
Competencies
- Interrogating Information
- Meeting Deadlines
- Following Procedures
- Maintaining Accuracy
- Customer Awareness
Accountability & Decision Making
Responsible to:
- Apply advanced knowledge of concepts, methods, terminology, codes, quality standards and specialised job requirements
- Provide updates to management on operational performance, work progress and quality
Decisions related to:
- Correct and/ or contain errors of significant impact
- Prioritise tasks and responsibilities within overall direction and clearly defined parameters/ schedules and established policies, practices, guidelines, and quality and safety checks
Deliverables
- Services are provided according to Production plan
- Method of analysis (MOA) is used for the analysis
- Problems are handled efficiently according to quality policy
- Feedback on outputs is reported regularly to customers
- HPLC/GC runs are checked regularly during the shift
- Products comply to GMP and quality standards, and product specifications
- Sampling and testing comply to GMP standards and SOPs
- Equipment calibrated according to procedure
- Internal customers provided with accurate HPLC/GC results
- Technology is utilised competently as per qualification requirements
- Good housekeeping maintained in lab
- Documents recorded and stored according to regulation
- Reports submitted on a weekly/ monthly basis
Reporting and Record-Keeping
- Document and store data according to SOPs and regulation
- Consolidate information for reports on weekly/ monthly basis
- Record, interpret and report testing results to management, including OOS results
Method of Application
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