Medical Writer

Aspen Pharma Group; Johannesburg; On-site; ZAR 500,000 - 650,000; Full time

Job summary

A global pharmaceutical company is seeking a Medical Writer in Johannesburg to support the commercial strategy. The role involves managing medical writing projects, preparing clinical documents for regulatory authorities, and coordinating interdepartmental reviews. Ideal candidates possess a B.Pharm or equivalent, extensive medical writing experience, and strong knowledge of regulatory guidelines. The position offers full-time employment and involves collaborating with various departments to ensure timely and high-quality submissions.

Qualifications

• 4 years of experience in the pharmaceutical industry.
• Strong knowledge of South African regulatory and medical authorities.
• Extensive medical writing experience.

Responsibilities

• Manage medical writing projects including timelines and quality.
• Write clinical documents for regulatory submissions.
• Coordinate interdepartmental reviews and document deliveries.

Skills

Regulatory knowledge

Medical writing

Project management

Attention to detail

Communication skills

Education

B.Pharm

B.Sc. (Hons)

B.Sc. Pharmacology

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Overview

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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 diversified 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 Group’s 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 Responsibilities

• 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 potential project challenges and suggest 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 to ensure information/documentation requests are delivered professionally and timely.
• Medical Writing Accountabilities
  • Ensure defined framework as set by PV Lead, RA Manager: Safety, Quality and Compliance, or Head of Department is 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, including copy editing and content review.
  • Ensure document content and style adheres to regulatory guidelines (FDA/EMA/SAHPRA or other) and complies with SOPs and style guidelines.
  • Perform literature searches/reviews to obtain background information for development of documents.
  • Prepare country-specific packs for submission of safety variations within ZA and other territories.
  • Assess documentation for suitability in support of new marketing authorisation applications (MAA) or new indications.
  • Prepare aggregate safety reports (e.g., PSURs, PBRERs) and Risk Management Plans.
  • Manage safety-related requests from regulatory agencies and Aspen Affiliates, ensuring timely responses.
  • Support training and mentoring within the department; participate in process improvement initiatives.
  • Develop formats, templates and guidelines for clinical documentation and workflows; assist in SOP/WI development.
  • Keep abreast of professional information and ensure transfer of knowledge to the department.
  • Maintain adherence to RA QMS and SOPs/WIs; participate in training programs.
  • Adhere to KPIs and uphold Aspen core values; ensure health & safety and confidentiality.
  • Any other duties as assigned by your Manager.

Educational Requirements

• Matric/ Grade 12
• B.Pharm (preferred); B.Sc. (Hons), B Sc. Pharmacology or equivalent scientific or clinical qualification

Knowledge & Experience Requirements

• 4 years of experience in pharmaceutical industry (clinical expertise)
• Strong knowledge of regulatory and medical authorities in South Africa
• Strong understanding of regulations, ICH guidelines, and GCP
• Extensive medical writing experience and expertise in submissions

Soft Skills Requirements

• Results and performance driven; integrity; strong work ethic
• Ability to meet deadlines; sense of urgency; curiosity; proactive ownership
• Excellent interpersonal and communication skills; problem-solving; autonomous work
• Customer focus; service orientation; flexible and confidential

Computer Skills Required

The applicant must be proficient in Word, Excel and PowerPoint within the Microsoft Office suite.

Preference will be given to previously disadvantaged groups. Suitably qualified applicants are invited to submit their CVs online on or before 1 June 2025. If you have not heard from HR within 30 days of the advert closing, your application has been unsuccessful. Internal applications must be completed using an Aspen mailing address after informing your direct line managers.

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Seniority level

• Associate

Employment type

• Full-time

Job function

• Health Care Provider

Industries

• Pharmaceutical Manufacturing

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