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Principal Regulatory Writer

  • Job type: Permanent
  • Location: Chicago
  • Salary: $120000 - $135000 per annum
  • Job reference: 3356852
  • Sector: EPM Scientific, Regulatory
  • Date posted: 26/01/2018
One of the leading companies in Pharmaceuticals is in search for a talented Principal Regulatory Writer to support their Immunology and Oncology teams. This is the perfect fit for a skillful regulatory writer who is looking to join a rapidly growing team and a company that prides itself on high-quality work and employee satisfaction. 

Job Overview 
  • Lead the preparation of all clinical and regulatory deliverables including but not limited to CSRs, Protocols, IBs, DSURs/PSURs, in collaboration with members of client authoring teams
  • Act as head project manager of assigned client deliverables and documents
  • Review all regulatory/clinical documents composed by outside sources
  • Ensure that all documents are aligned with agreed timelines, manage project budgets, adhere to relevant SOPs, and meet the requirements of assigned client(s)
  • Responsible for providing document-specific advice to clients
Skills Required 
  • BA/BS within a scientific discipline, advanced degree preferred
  • At least 3-5 years of clinical and regulatory writing experience within the pharma/biotech industry
  • Has acted as the lead writer on >3 of at least 3 of the following: Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications
  • Exceptional written and verbal communication skills
  • Competency in the using document management systems
  • Knowledgeable in ICH, EMEA and FDA guidelines.
 




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