Medical Writer

  • location: Princeton, NJ
  • type: Permanent
  • salary: $100,000 - $110,000 per year
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job description

Medical Writer

job summary:
**IMMEDIATELY SEEKING a Medial Writer that will assist in preparing complex clinical documents, such as: study protocols/amendments, clinical study reports, investigator's brochure, abstracts/manuscripts and sections of regulatory submission documents.**

 
location: Princeton, New Jersey
job type: Permanent
salary: $100,000 - 110,000 per year
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Authorize clinical documents that include clinical protocols/amendments, investigator's brochures, clinical study reports, and sections of regulatory submission documents BLA/NDA/MAA. Other documents may include health authority briefing books, and scientific publications, abstracts/presentations.
  • Produce high quality and on-time writing deliverables ensuring scientific consistency between related documents or studies in a clinical program
  • Oversee internal and external deliverables with respect to document quality and develop medical writing timelines, processes, standards, and innovative initiatives
 
qualifications:
  • Bachelor's Degree in a relevant scientific field, Master's or Doctorate Degree preferred
  • A minimum of 5 years medical writing experience in a pharma, biotech, or CRO setting
  • In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.
  • Experience with regulatory submissions and knowledge of eCTD highly desired
  • Technical expertise in Word, Excel, PowerPoint, Adobe Acrobat, document management systems, common templates of clinical regulatory documents
  • Excellent written and verbal communication skills, with the ability to clearly present clinical data
  • Strong organizational skills with the ability to effectively multi-task and prioritize
 
skills: Editing, NDA, Maa
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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