Stratacuity: Proven Scientific Placement

  • Watertown, MA, United States
Stratacuity: Proven Scientific Placement Watertown, MA, USA
Location : Watertown, MA (Remote) Science/ Focus: Small Molecule Therapeutic Area(s): Viral infections and liver diseases Job Overview: This individual will lead medical writing activities for clinical documentation preparation to support the advancement of clinical-stage programs. Responsibilities: Coordinate the preparation and timely delivery of high-quality documents for domestic and international regulatory filing and clinical programs Produce documents to support clinical trials and regulatory submissions, in accordance with domestic and international regulations and guidelines Prepare detailed timelines of writing activities for assigned documents and validate dates with all impacted document production team members Research and recommend external partners, and monitor the quality and progress of subcontracted writing activities Lead the development of clinical protocols and amendments, investigator’s brochures (IBs), clinical study reports (CSRs),...