Medical Writer I, II or III
Mitsubishi Tanabe Pharma AmericaJersey City, New Jersey, United States
Posted March 30, 2017
Full Time
About the Company
Entrepreneurial spirit, rooted in tradition. Mitsubishi Tanabe Pharma Development America is a research-driven pharmaceutical company with global reach.
Job Description
Medical Writer I, II or III at Mitsubishi Tanabe Pharma Development America. Provide regulatory documents support to clinical teams, researching and writing high-quality documents for submission to FDA and EMEA. Collaborate with cross-functional teams and projects, developing project timelines and guidelines for clinical documentation.
Requirements
- BA/BS in a related scientific discipline
- Advanced scientific degree (MS, Pharm D, PhD) preferred
- 2-8 years of medical writing experience in a pharmaceutical or clinical/contract research organization
- Ability to analyze and interpret complex clinical and non-clinical statistical reports
- Expertise in clinical research documentation and regulations (FDA, EMEA, ICH) and GCP
- Project management skills and attention to detail
- Excellent written and oral communication skills
Benefits
- Medical/Dental Life Insurance
- Supplemental Life Insurance/Dependent Life Insurance
- Accidental Death & Dismemberment Insurance
- Business Travel Accident Insurance
- Short-Term Disability
- Long-Term Disability
- Flexible Spending Accounts
- Employee’s Savings Plan (401K Plan)
- Competitive Paid Time Off