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Manager, Medical Writing

  • Job type: Permanent
  • Location: Trenton
  • Salary: $120000 - $140000 per annum
  • Job reference: SYNK4234
  • Sector: EPM Scientific, Regulatory
  • Date posted: 04/12/2017
Our client is located near Trenton, NJ and is one of the industry leaders in the medical device field! We are looking for an experienced and highly motivated Medical Writing Manager. In this position, you will be responsible for delivering high quality regulatory documents in junction with regulatory guidelines that meet ICH standards. You will be required to prepare and coordinate clinical submissions (IND,IMPD,NDA,MAA/sNDA) and a variety of clinical documents including patient narratives, investigator brochures, CSRs and SOPs.

Did I mention this position can be worked remotely??

Basic Qualifications:
  • B.S. degree.
  • 7-10 years of experience in regulatory writing within the pharmaceutical industry, including managing global registration dossiers.
  • Understanding of electronic based document management system.
  • Practice working with regulatory affairs groups and systemizing regulatory strategies.
  • ICH guideline knowledge as well as EMEA and FDA regulatory guidelines.
  • Exhibit excellent written/oral communication skills.
  • Talented multitasker that can meet deadlines.
  • Ability to adapt and interact efficiently in team settings.
Preferred Qualifications:
  • Advanced degree in Life Sciences.
  • Background with diagnostic imaging agents.
  • Vendor/consultant management experience.
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