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Senior Medical Writer

3 months ago

Aurangabad, India SciVoc™ Consulting Inc. Full time

SciVoc Consulting Inc. is a rapidly emerging medical and scientific writing consultancy that aims to impact patient lives through meaningful communications - medical, scientific and commercial.


Our growing team is looking for a Senior Medical Writer (only Regulatory) with over 7-8 years of working experience in a pharmaceutical organization, a clinical research organization, or a medical writing agency.


Responsibilities

  • Leads medical writing assignments independently and can communicate effectively across teams and clients with minimal supervision.    
  • Ability to interpret and present clinical data and other complex information across all phases of clinical trials in a concise, accurate, and simplified manner. 
  • Develops, coordinates, or supports documents that include, but are not limited to:


  1. Clinical study protocols and protocol amendments;
  2. CSRs;
  3. Patient narratives;
  4. IBs and ICFs;
  5. Clinical development plans;
  6. IND submissions and annual reports;
  7. Integrated summary reports;
  8. CTD, ACTD, conversion of non-CTD to eCTD;
  9. NDA and (e)CTD submissions;
  10. Dossiers;
  11. PSUR, DSUR, Safety Update Reports.


  • Ability to work across complex therapy areas with minimal support. Demonstrates advanced knowledge of current industry practices, regulatory environment, and relevant guidelines.
  • Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client-approved templates when completing medical writing projects on time and budget.
  • Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency.
  • Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
  • Completes required administrated tasks within the specified timeframes, within budget, and with high quality.


Qualifications

  • Master of Science degree with relevant writing experience or Pharm D, or PHDs or any relevant medical degree with appropriate scientific and/or medical knowledge and expertise.
  • Advanced knowledge of English grammar and FDA and ICH regulations and guidelines.
  • Excellent communication skills - written and oral; proactive and problem-solving aptitude.
  • Demonstrated a high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensured a team-oriented approach.