Senior Medical Writer Remote at PharmiWeb.

Senior Medical Writer - Bloemfontein, South Africa
Office-based or remote

Who We Are

Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of "Bringing Clinical Trials to Life," we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare.

Specific Tasks Would Include

• Interprets clinical study results and write, review and/or edit clinical study documents.
• May translate clinical study documents.
• Performs QC reviews on documents developed by other writers.
• Prepares scientific manuscripts, abstracts, posters.
• May review scientific literature, product information and evaluate product data.
• Assists in the development of formats and guidelines for clinical documents.
• Trains other medical writers.
• Reviews of work products of junior staff.
• May cross-train individuals from other departments in QC review of CSRs.
• Assists with writing and/or reviewing of SOPs.
• May serve as the primary point of contact for MW on project teams.
• Keeps abreast of professional information and technology, industry practices and regulatory guidance affecting medical writing through attendance at conferences or professional meeting.
• Archives clinical documents prepared by the medical writing group.
• Conducts activities within budget requirements as instructed by the Project Manager.

 

Qualifications

• Advanced degree in a scientific, medical or statistical discipline and at least 5 years experience or equivalent combination of education and experience.
• Familiarity with relevant ICH, CTD/eCTD and FDA guidances, and GCP
• Familiarity with medical terminology.
• Excellent Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, Internet Explorer and Adobe Acrobat.
• Effective verbal and writing skills; English + local language, if relevant