Senior Medical Writer
Skills
Analytical SkillsBiotechnologyGood Clinical PracticeHealthcareIndustry StandardsInternational RegulationsLeadership
What the job involves
The main requirements, responsibilities and hiring steps.
Requirements
- Bachelor’s degree in science or a health profession
- Required 5+ years medical writing experience in pharma or biotechnology
- 3+ years experience with electronic documents and submissions
- Required experience writing CSR IBs and protocols
- Experience managing writing activities for major international regulatory submissions
- Strong understanding of clinical development across all phases
- Knowledge of ICH guidelines international regulations and CTDs
- Excellent oral and written communication skills
- Demonstrated problem solving and interpersonal skills
Nice to have
- Independent
- Detail-oriented
- Collaborative
- Analytical
- Proactive
- Leadership-minded
Day to day
- Leads the preparation of complex regulatory and clinical documents with strong scientific accuracy and clear structure.
- Coordinates writing assignments reviews and substantive edits while developing timelines and resource plans for major submissions.
- Provides expert guidance on clinical development regulatory strategy and document standards across cross functional project teams.
Hiring process
- Submit application
- Reasonable accommodation available on request
- Equal consideration for qualified applicants