Job Description

COMPANY DESCRIPTION
We are a global specialty and branded pharmaceutical company, improving the health of patients across the world through our high quality and affordable medicines. Active at every stage of the value chain, we are uniquely diversi?ed by geography, product and manufacturing capability.
Aspen is a dynamic organization built on entrepreneurial strength and forward-thinking minds. We attract high performing individuals who are passionate about their career and have a desire to exceed expectations. At Aspen, not only do we source for the best talent, but we also provide a host of opportunities for continuous development.
The Groups key business segments are Manufacturing and Commercial Pharmaceuticals comprising Regional Brands and Sterile Focus Brands. We have approximately 9 100 employees at 69 established offices in over 50 countries and we improve the health of patients in more than 150 countries through our high quality, affordable medicines.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. To establish a central point of contact for all medical writing project for the Regulatory Affairs South Africa entity of the Aspen Group by liaising with other Pharmacare departments as the need arises. To undertake all research, creation and editing of all documents to comply with safety and clinical updates accordingly to the Pharmacare Company Core Datasheet (CCDS).KEY RESPONSIBILITIESFinancial
xc2xb7Project management of contractual and financial aspects of all medical writing projects and the effective utilisation of resources to keep processes cost effective.
xc2xb7Identification of project challenges to departmental line management and the financial
xc2xb7impact thereof.Project Management
xc2xb7Act 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.
xc2xb7Project management of contractual and financial aspects to be performed with management where necessary.
xc2xb7Serve 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.
xc2xb7Coordinate and conduct interdepartmental team review and sign-off of document deliverables according to Pharmacare guidelines/SOPs.
xc2xb7Coordinate 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.
xc2xb7Attend internal and technical team meetings as required.
xc2xb7Assist management as needed with preparation of resourcing estimates for potential new medical writing projects
xc2xb7Proactively engage with other departmental resources where necessary to ensure that information/documentation requests are delivered in a professional and timeous manner.Medical Writing Accountabilities
xc2xb7Ensure defined framework as set by PV Lead, RA Manager: Safety, Quality and Compliance, or Head of Department are executed within the specified timelines.
xc2xb7Write clinical documents for submission to regulatory authorities, including but not limited to:o clinical overviews and summaries
o clinical expert statements
o interim and final clinical study reports
o integrated summaries of safety and efficacy
o nonclinical overviews and summaries
o 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.xc2xb7Ensure document content and style adheres to FDA/EMA/SAHPRA or other appropriate regulatory guidelines, and complies with departmental and corporate SOPs and style guidelines
xc2xb7Perform literature searches/reviews to obtain background information and training for
xc2xb7development of documents
xc2xb7Prepare country specific packs for submission of safety variations within ZA and other
xc2xb7territories
xc2xb7Assist in the assessment of clinical and nonclinical documentation with regards to its suitability for supporting new marketing authorisation applications (MAA) or new indications.
xc2xb7Preparation of aggregate safety reports including but not limited to PSURs, PBRERs and Addendum Safety Reports.
xc2xb7Preparation of Risk Management Systems including but not limited to Risk Management Plans, Healthcare Professional Letters and Risk Communication Plans.
xc2xb7Request for Information from Competent Regulatory Authorities (CRAs)
xc2xb7Manage safety related requests from regulatory agencies and Aspen Affiliates to ensure any requests are answered fully and promptly.
xc2xb7Assessment of local PI/PIL for inclusion of the validated signal.
xc2xb7Data analysis of signals and feedback to the Safety Review Team (SRT) during the Signal Management meetings.
xc2xb7Provide training and guidance and act as a mentor to less experienced departmental
xc2xb7members.
xc2xb7Initiate and participate in departmental or interdepartmental process improvement and
xc2xb7training initiatives.
xc2xb7Initiate and manage development of formats, templates and general guidelines for clinical
xc2xb7documentation and workflow procedures.
xc2xb7Assist in the development of departmental SOPs/WIs.
xc2xb7Keep abreast of professional information and technology through
xc2xb7workshops and conferences and ensure the appropriate transfer of that information to the department.
xc2xb7Ensure systems and procedures are in place in accordance with the RA QMS and that these are maintained according to the relevant SOPs
xc2xb7Adhere to agreed Key Performance Indicators (KPIs).
xc2xb7Support the continuous development and improvement of the PV function while upholding Aspen core values.
xc2xb7Maintain rigorous adherence to written procedures, e.g. SOPs/WIs.
xc2xb7Adherence to Company Health & Safety procedures.
xc2xb7Participate in training programmes.
xc2xb7Any other duties as assigned by your Manager.EDUCATIONAL REQUIREMENTS
xc2xb7Matric/ Grade 12
xc2xb7B.Pharm (preferred); B.Sc. (Hons), B Sc. Pharmacology or equivalent scientific or clinical qualificationKNOWLEDGE & EXPERIENCE REQUIREMENTS
xc2xb74 Years experience in pharmaceutical industry (clinical expertise)
xc2xb7Strong knowledge of regulatory and medical authorities in South Africa
xc2xb7Strong understanding of regulations, ICH guidelines, and GCP
xc2xb7Extensive medical writing and expertise in submissionSOFT SKILLS REQUIREMENTS
xc2xb7 Results and performance driven deliver results that meet or exceed expectations
xc2xb7Integrity
xc2xb7Work ethic
xc2xb7Ability to meet deadlines
xc2xb7 Sense of urgency responding to issues and opportunities in a timely manner
xc2xb7 Intellectual curiosity willing to suggest and try new ideas
xc2xb7Positive and pro-active approach to business tasks
xc2xb7Excellent interpersonal and communication skills
xc2xb7A solutions provider
xc2xb7Manage evolving deadlines effectively with regular feedback and updates
xc2xb7Enthusiasm and Drive to take ownership and drive process initiatives
xc2xb7Service orientation
xc2xb7Customer focused
xc2xb7Logical thinking
xc2xb7Information seeking
xc2xb7 Positive xe2x80x98can do attitude
xc2xb7Be able to work autonomously and have good problem-solving skills
xc2xb7Able to cope with evolving deadlines effectively with regular feedback and updates
xc2xb7Honest and trustworthy
xc2xb7Respectful and highly personable
xc2xb7Possess cultural awareness and sensitivity
xc2xb7Flexibility & confidentiality are key requirements for this role.COMPUTER SKILLS REQUIRED
The applicant must be proficient in the various applications (Word, Excel and PowerPoint) within the Microsoft Office bundle.Preference will be given to previously disadvantaged groups. Suitably qualified applicants are invited to submit their CVs online on or before 1 June 2025. Please note that if you have not heard from the HR department within 30 days of this advert closing, your application has unfortunately been unsuccessful.Internal Applications must be completed using an Aspen mailing address after applicants have had informed their direct line managers of their application for this specific role.