Medical Writer
$124,800–$124,800 year
On-siteNew Milford, New Jersey, United States
Job Summary
Prepare, edit, and finalize high-quality clinical and regulatory documents including protocols, Investigator's Brochures, and summaries for IND, NDA, and BLA submissions. Manage the full document development lifecycle from drafting to final approval, ensuring scientific integrity, accuracy, and adherence to Good Publications Practice Guidelines. Serve as the medical writing representative on cross-functional study teams, providing guidance on strategy, timelines, and resource needs while collaborating with internal and external contributors. Monitor regulatory findings to ensure key messages remain consistent across deliverables and participate in necessary meetings to align stakeholders. Maintain familiarity with US and international regulations to support submissions within agreed-upon timelines.
Required Qualifications
- Minimum of 5 years of relevant medical writing experience in a pharmaceutical, biotechnology, CRO, or related environment
- Bachelor's degree in life sciences or related disciplines
- 5+ years of clinical research experience
- Strong attention to detail
- Ability to multi-task
- Unquestionable integrity and highest ethical standards
- Excellent written and verbal communication skills
- Self-motivated, assertive, and driven
- Basic knowledge and adherence to GCPs
- BA, BS, RN, BSN or equivalent
Desired Qualifications
- advance degree preferred (MD, PhD, PharmD, etc.)
- Experience in supporting the publication of meeting abstracts or journal manuscripts is a plus
- Bilingual in Mandarin and English is not required, but will be a plus
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