Accessibility Links

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.
 




Similar jobs
Medical Director
  • Job type: Permanent
  • Location: Parsippany-Troy Hills, New Jersey
  • Salary: US$120000 - US$160000 per annum
  • Description Job description: High performing agency located in New Jersey is looking for a full time Medical Director to help impact the success of the agency. As Medical Director
Senior Medical Writer - Medical Communications
  • Job type: Permanent
  • Location: Yardley, Pennsylvania
  • Salary: US$80000 - US$100000 per annum
  • Description Summary of Job: A top tier Medical Communications agency focused on publication planning is looking for a Senior Medical Writer to join the team as a lead content creator
Freelance Medical Writer
  • Job type: Contract
  • Location: England
  • Salary: Competitive
  • Description ***A Global Medical Device Company is looking for 3X Home-based Freelance Medical Writers to take part in a 12 Month Project, starting in September*** Responsibilities: 0
Director of Regulatory Affairs
  • Job type: Permanent
  • Location: Massachusetts
  • Salary: US$180000 - US$200000 per annum
  • Description A leading global pharmaceutical company is looking to build out a brand new regulatory affairs team for a promising new project. Director of Regulatory Affairs| Regulatory Affairs | Oncology
Commercial Product Planning Associate Director: Liver Fibrosis
  • Job type: Permanent
  • Location: San Francisco, California
  • Salary: 401k + Bonus
  • Description Associate Director Global New Product Planning, Liver Fibrosis San Francisco Biotech