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Medical Writer-SOA (State-Of-the-Art)

Full-Time

Bengaluru, India

Hyderabad, India

Primary Job Responsibilities :

  • Participates in planning and executing the SOA outline/library
  • Perform literature activities, such as, screening, data extraction, analysis, and synthesis for the SOA libraries
  • Extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries highlighting any new findings
  • Identifies new adverse events
  • Review the risk/benefit data to update SOA

 

Secondary Job Responsibilities :

In preparation for the SOA activities, the SOA Medical Writer is expected to perform general CER medical writing tasks – plans and executes general medical writing activities and systematic literature reviews primarily for the generation of Clinical Evaluation Reports (CER) for assigned therapeutic area and projects. The high-level activities may include:

  • Participates in the planning and execution of general medical writing activities and systematic literature reviews for assigned therapeutic area.
  • Prepares, writes, and edits creditable systematic literature reviews through the creation of protocols and reports in order to synthesize and analyze the clinical data from medical and scientific publications reporting on a range of medical devices.
  • Participates in core process steps for systematic literature reviews including search, screen, data extraction, analysis, and synthesis of the literature for CER processes.
  • Performs data extraction of included studies into a data collection tool (e.g. Microsoft Excel, Distiller).
  • Utilizes software to support the core process steps for systematic literature reviews including statistical analysis tools (e.g. Distiller, QUOSA, SAS) 
  • Extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports.
  • Organizes clinical data from literature into references, graphics, tables, and data listings. 
  • Critically synthesizes clinical data being considered for presentation in the final report. 
  • Performs scientific writing of the synthesized literature using templates.
  • Interprets and summarizes complex results from the medical and scientific literature and present them in clear, concise, and scientifically accurate manner to various end users requiring the ability understand and interpret statistical results of clinical studies.  
  • Presents the results of systematic literature reviews at internal meetings.

 

Candidate Profile :

  • Candidate must be MDS / M.Pharm / PhD.
  • 2-3 years of relevant training or quality experience with 5 years overall business experience required. 
  • Experience working in a highly matrixed, global organization is preferred. 
  • Excellent organizational, verbal and written communications skills are required.
  • Demonstrated problem solving skills and proven ability to develop and maintain effective business partnerships is a requirement. 
  • Candidate should have experience in MS Office Suite (Word, PowerPoint, Excel, Outlook).
  • Knowledge of SharePoint administration.
  • Process and detail-oriented.
  • Managing achievement of competing priorities and deadlines.

 

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