MMS Hiring Safety Writer

MMS Hiring Safety Writer

16 June, 2022

MMS Hiring Safety Writer

Roles and Responsibilities

  • Responsible for writing safety documents intended for submission to regulatory agencies.
  • Responsible for writing patient CSR narratives and producing high quality documents
  • Practices excellent internal and external customer service
  • Good understanding of MS Word for advanced writing techniques
  • Address client comments during document lifecycle, manage revisions, and review deliverables with limited mentor oversight prior to releasing to client
  • Ensure documents comply with appropriate ICH and regulatory guidelines
  • Interact directly and independently with client
  • Ability to follow MMS and sponsor processes
  • Practices internal and external leadership skills

Job Requirements (Minimum Education / Experience / Training / Skills)

  • Experience in CSR narratives and aggregate reports
  • University graduate in scientific, medical, clinical discipline or related field, or related experience
  • Prior medical/ narrative/ safety writing experience preferred; Interested in expanding knowledge of drug development as it pertains to narrative writing
  • Master’s or PhD in a scientific, medical, or clinical discipline preferred
  • Min 4 years’ experience with regulated scientific/clinical or pharmaceutical, biotech or clinical research environment 
  • Understands ICH guidelines, as applicable to medical writing for clinical studies
  • Excellent written English skills
  • High degree of organization and able to manage multiple projects at any given time
  • Attention to detail and committed to excellence in all aspects of their work
  • Excellent communication and interpersonal skills
  • Proficient in Microsoft Word and Adobe Acrobat
  • Experience in the use of an Electronic Document Management system

Apply Here

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