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Manager, Medical Writer

  • Job type: Permanent
  • Location: Boston
  • Salary: $100000 - $120000 per annum
  • Job reference: 332659
  • Sector: Medical Affairs, Pharmacology, EPM Scientific
  • Date posted: 02/02/2018
One of the leading companies in Pharmaceuticals is in search for a talented Manager, Medical Writing. 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. The Medical Writing Manager will work closely with Research, Clinical Operations and Regulatory Affairs to manage all document submissions for both clinical and regulatory documents.

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: SOPs, GCP and ICH, and meet the requirements of assigned client(s)
  • Responsible for providing document-specific advice to clients
  • Ability to interpret and present clinical and non-clinical data objectively in a clear, concise format
 


Skills Required 


  • BA/BS within a scientific discipline, advanced degree preferred
  • At least 3-5 years of clinical and regulatory writing experience within the pharmaceutical/biotechnology or CRO 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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