Medical Writer - CONSULTANCY

The objectives of Competence Center for Methodology & Statistics (CCMS) are to provide high-standard statistical and data-processing support, and to maintain high ethical standards as regards to research, the reporting and analysis of statistics and the preparation of data-bases.

We are seeking candidates who are regulatory medical writers (not medical communication) to assist in the development, drafting, review, editing, and finalization of a clinical trial protocol and associated statistical analysis plan, specifically:

• Draft and edit documents used in conduct of a clinical study including protocols, protocol amendments, statistical analysis plan, and informed consent forms,
• Adhere to departmental procedures and practices and technical and industry standards during all aspects of work,
• Work effectively with cross-functional groups, including regulatory, clinical pharmacology and statistics.

Skills (one of the following)

• Medical writer in the pharmaceutical industry
• Medical or scientific writing experience as a primary job responsibility

Key Skills, Experience and Qualifications

• Bachelors degree of higher scientific degree (Master or PhD preferable)
• At least 5 years’ experience required
• Familiar with the drug development process (discovery to market), clinical study protocol design and study conduct, and documentation required for the conduct of clinical studies.
• Familiar with clinical study data collection and results reporting.
• Previous protocol development experience required.
• Intermediate to advanced applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and guidance documents that prescribe content.
• Intermediate applied knowledge of basic clinical laboratory tests.
• Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug).
• Ability to interpret basic tabular and graphical clinical data presentations.
• Intermediate to advanced knowledge of regulatory requirements and guidelines (US FDA) associated with trial protocol and statical analysis plans.
• Basic understanding of biostatistical and clinical research concepts. Proficient in Microsoft Word (including the use of templates), Excel, and PowerPoint.
• Evidence of medical writer career desirable.
  
  
  

A motivation letter is not mandatory.

Companies and individuals can apply.