Principal Medical Writer
Bloemfontein, South Africa
6d ago

Who We Are

Synteract®, a Syneos Health® company, is a leading full service Contract Research Organization (CRO) with a successful three-decade track record of supporting emerging biotech and pharmaceutical companies.

We provide customized Phase I through IV services globally, offering expertise across multiple therapeutic areas, including notable depth in oncology, dermatology, general medicine, infectious disease and vaccine, neuroscience, pediatrics, and rare and orphan diseases.

Position Overview As a Principal Medical Writer you will write or perform quality review of medical writing deliverables in compliance with regulatory guidelines, style templates and Standard Operating Procedures (SOPs).

Specific tasks would include :

  • Contributes to clinical study reports (CSRs) and appendices.
  • Perform quality reviews on documents developed by other writers.
  • Assists in preparation of other medical writing deliverable.
  • Maintains familiarity with current industry practices and regulatory requirements that affect medical writing.
  • May serve as the primary point of contact for medical writing on project teams.
  • Conducts activities within budget requirements as instructed by the Project Manager and alerts PM to any change in scope.
  • Reviews statistical analysis plans and table / figure / listing specifications for appropriate content, and for grammar, format, and consistency.
  • Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as company SOPs, client standards, and company and / or client approved templates when completing medical writing projects, on-time and on-budget.
  • Interprets clinical study results and writes, reviews, and / or edits clinical study documents.
  • Prepares scientific manuscripts, abstracts, and posters.
  • May review scientific literature, product information and evaluate product data.
  • Provides medical writing deliverables covering all phases of clinical research and in various therapeutic areas
  • Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
  • Trains other medical writers.
  • Reviews work products of junior staff.
  • Assists with writing and / or reviewing of Controlled Documents.
  • Keeps abreast of professional information and technology, industry practices, and regulatory guidance affecting medical writing through attendance at conferences or professional meetings.
  • Provide project management support as necessary, including managing project budgets and ensuring MW projects meet agreed timelines.
  • Leads and manages medical writing projects including the design, planning, and preparation of clinical study documents and regulatory documents.
  • Mentors and leads less experienced medical writers on complex projects.
  • Coordinates with other writers, PMs, and line management on large, complex projects, such as new drug applications (NDAs), biologic license applications (BLAs), and marketing authorization applications (MAAs).
  • Represents the Medical Writing department on clinical study teams and at conferences and meetings regarding writing project.
  • Advises clients and study teams on data presentation and production strategies and on data interpretation.
  • Compiles, writes, and edits medical writing deliverables, and serves as a medical writer on inter-department and intra-department project teams in an independent manner.
  • Serves as peer reviewer on internal review team.
  • Performs on-line clinical literature searches.
  • Qualifications

  • Advanced degree in a scientific, medical or statistical discipline or minimum 8 years of experience or equivalent combination of education and experience.
  • Adept with concepts in study design, specializing in a key therapeutic areas,
  • Ability to manage multiple medical writing deliverables simultaneously.
  • Ability to work with cross-functional teams to complete medical writing deliverables within predefined timelines.
  • Advanced proficiency in Microsoft Word, MS Project, Excel, and PowerPoint, Outlook
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