About the role
- Prepare and lead the medical writing team on Phase I-IV study documents
- Work with other departments in Worldwide preparing and leading the development of Pre-IND documents
- Responsible for key documents template management
- Serve as publishing point-of-contact in conjunction with the Publisher for CTRs or other documents
Requirements
- University/college degree (life science or related allied health profession)
- Minimum of 4 years of experience as a Medical Writer or equivalent role
- Excellent written and spoken English
- Ability to accurately interpret data and express findings in a clear manner
- Excellent project/time management and organizational skills
- Flexibility in meeting challenging deadlines and changing requirements
- Comprehensive Microsoft Office skills, especially Word
- Thorough knowledge of applicable regulatory requirements and guidelines (in particular ICH E3, E6, and E9)
- Ongoing training and career development
- Cohesive and supportive teams
- Diverse and inclusive environment
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
medical writingPhase I-IV study documentsPre-IND documentstemplate managementdata interpretationregulatory requirementsICH E3ICH E6ICH E9
Soft skills
excellent written communicationexcellent spoken communicationproject managementtime managementorganizational skillsflexibilityability to meet deadlines