Senior Associate, Report Publishing

Senior Associate, Report Publishing

Location: Northern NJ (Bergen County)

DIRECT HIRE

Industry: Pharma

Must haves:

  • eCTD experience, bookmarking hyperlinking, utilizing ISI toolbox
  • Expert with templates and the ability to convert document to quick capture
  • Ability to communicate effective with various groups – CRO’s, Reg Affairs, Med Affairs
  • Understanding of ICH guidelines
  • Solid knowledge of report publishing processes and requirements in the global market place
  • Strong background in the various report types (e.g. DSUR, PSUR, IMPD, CSR, etc.)

 

The role:

  • Provide report publishing expertise and general back up support to the global Report Publishing group.
  • Provide expertise for Report Publishing in archiving and maintenance of departmental documentation.

 

Responsibilities include:

  • RP global report publishing activities
  • RP process management
  • Back-up assistance as required by RP global publishing team
  • Provide cross functional support

 

Job Qualifications

  • BS (Life Science or related discipline) with minimum 3 years of industry experience, or BA with minimum 5 years of report publishing experience in pharma industry
  • Excellent knowledge of written and spoken English
  • Good knowledge (or capability) of electronic software programs and processes applied by Regulatory Operations as well as key processes of Regulatory Affairs
  • In-depth understanding of ICH guidelines and eCTD submissions
  • Excellent working knowledge of Word, Excel and PowerPoint software
  • High attention to detail, strong organizational/project management skills, work independently, self-motivated and proactive
  • Strong customer focus
  • Strong communication skills
  • Strategic thinker
  • Accepted file types: doc, pdf, txt, docx.