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
- 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
- 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.