Jobs at PAREXEL

We are currently recruiting a Senior Medical Writer based in South Africa, who will work as part of the Drug Safety writing team.

• The Senior Medical Writer is responsible for comprehensive signal management, including detection, analysis, and evaluation from various sources.
• They oversee the end-to-end signal management process, collaborate with client safety science , and adhere to client-defined plans and SOPs.
• The PMW also contributes to preparing, updating, and managing various safety documents including Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), and other aggregate reports.  
• This position requires expertise in pharmacovigilance processes and the ability to manage complex safety data. 
• This role also focuses on training junior staff, and requires strong communication, and problem-solving skills, balancing mentoring  and client relation and requires expertise in pharmacovigilance, strong analytical skills, and the ability to collaborate across functions to ensure comprehensive product safety management across multiple therapeutic areas.

Knowledge and Experience:

• Relevant experience is desirable in Regulatory/ Pharmacovigilance or related field.
• Good knowledge of medical terminologies

Education:

• Science/Medicine degree: The minimum qualification required would be a university degree in life Sciences/Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.)
• A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage

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Responsibilities

• Program simple to complex data review listings, exception reports, QTL/KRIs, metrics reports and visualizations in a fast-paced environment for clinical trial data review and management purposes.
• Liaise with Clinical Data Management and/or cross functional staff to understand the needs of the end users of the listings, reports, and metrics.
• Contribute to the development of software systems and related infrastructure to generate displays of clinical study data and metrics reports that are efficient and user-friendly.
• Create and document archives of software and deliverables.
• Create any Work Instructions process and training documents needed related to clinical programming and the required deliverables.
• Provide time and resource estimates for project planning as well as accurately record time spent on multiple deliverables.

Here are a few requirements specific to this advertised role.

• Bachelor’s degree in computer science, Statistics, Mathematics, Life Sciences or other relevant scientific fields.
• Minimum of 5 years of experience in developing software in a clinical trial environment using SQL, including at least 3 years of clinical programming experience.
• Skilled in programming in a relational database setting with SQL and/or T-SQL or ETL.
• Experience with data reporting tools in a clinical trial setting.
• Experience in the Biotechnology, Pharmaceutical, or Life Sciences industries (Clinical Research Organization - CRO or Clinical Trial regulated environment preferred).
• Experience with the eClinical Solutions elluminate platform a plus; experience with Qlik Sense a plus.

Preferred additional external data transfer experience in:

• Creating external data transfer specifications, ensuring external clinical trial data are compatible with the clinical database to support data integration, analysis and reporting.
• Experience in planning, set-up, and acquisition of external clinical data at the study level
• Liaising with and reviewing work delivered by external partners (e.g. laboratories, eCOA providers, technology providers, etc.)
• Knowledge of some additional programming languages (e.g.: SAS, PL/SQL, R, Python, Java, …) a plus.
• Ability to balance and prioritize multiple assignments and respond quickly to ad hoc requests.
• Familiarity with CDISC standards, including CDASH and SDTM.
• Working knowledge of Microsoft products: Outlook, Word, Excel, Teams.
• Excellent verbal and written communication skills.
• Strong English language written and verbal communication skills.
• We care about our people and your passion, as they are the key to our success, and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers.
• In addition, you will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel.