Assistant Submission Manager (Editor)

South San Francisco, California 94080 | Contract

Post Date: 04/16/2018 Job ID: 4125 Industry: Regulatory Affairs & Compliance

Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.

 

Duties:
  • The Assistant Submission Manager in the Submission Management Group, Pharma Technical Regulatory (PTR), supports PTR product managers by managing the flow of CMC regulatory documents through preparation and review with adherence to applicable regulatory and Roche documentation standards.
  • Responsibilities include document editing, proofreading, and formatting submissions to the FDA and other regulatory agencies.
  • Additionally, the Assistant Submission Manager may be expected to format detailed data tables and figures and apply document formats using customized Word templates.
  • Other responsibilities include  facilitating adjudication meetings, compiling regulatory dossiers and formatting them for publishing, handing over dossiers for publishing, and maintaining regulatory documents in document-management systems and document-sharing systems.
  • The position requires strong project coordination skills and close collaboration with authors (scientists and other subject matter experts), regulatory affairs specialists, and the publishing group.

 

 

Skills:

  • Strong track record as an editor, including at least three years of professional editing experience, preferably in a scientific or technical field.
  • Tenacious attention to detail and consistency, especially with respect to grammar, usage, spelling, punctuation, and style; familiarity with standard style guides.
  • Thorough knowledge of eCTD and CTD filing requirements, as well as global filing requirements. In-depth knowledge of document management best practices
  • Proficiency in a broad range of IT skills, including expert-level use of Word, Excel, and Acrobat and experience with document-management systems (e.g., Documentum/IDM) and document-sharing systems (e.g., SharePoint) and knowledge of global collaborative IT solution products.
  • Knowledge of publishing systems and requirements is beneficial Ability to manage multiple, often lengthy documents simultaneously and meet demanding deadlines.
  • Ability to work flexibly to support changing assignments and priorities.
  • Ability to communicate clearly and professionally, both orally and in writing; ability to communicate in an international environment.
  • Proficiency with Excel, Acrobat.
  • Experience with document management and sharing systems is desirable.

 

Education:

  • BS or BA in English, biology, chemistry, pharmacy, or a related field
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