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Principal/Lead Medical Writer

2 months ago

Nellore, India SIRO Clinpharm Pvt. Ltd. Full time
  • Advanced degree in a relevant scientific/clinical/regulatory field preferred; Bachelor’s degree is required.
  • At least 7 years of experience writing clinical/regulatory documents for a pharmaceutical or biotechnology company is required.
  • Experience as lead writer for key documents included in major US and/or international regulatory submissions required.
  • Experience managing writing activities for a major US or international regulatory submission (project or people management) preferred.
  • Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products.
  • Understanding of FDA/international regulations, ICH guidelines, and applicable US/interna-tional regulatory processes related to document preparation and production (including CTDs).
  • Well-developed oral and written communication skills; ability to clearly present technical in-formation within and across functional areas.
  • Demonstrated problem-solving and interpersonal skills that facilitate effective interactions within functional and cross-functional teams and with external providers.
  • Knowledge of team dynamics and ability to function as a team leader.