Sr. / Principal Medical Writer
New
J
JobgetherLife Sciences
Remote opportunity also open across the United States, United Kingdom, and CanadaFull-TimeSenior
Salary$80,600–$175,700 annual base salary range
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Job Details
- Experience
- Minimum of 5 years of lead regulatory medical writing experience.
- Required Skills
- Project Management
Requirements
- Minimum of 5 years of lead regulatory medical writing experience.
- Proven experience as lead writer for Phase 2 and 3 clinical development programs.
- Demonstrated lead-writing experience for protocols, regulatory submissions, CTD Modules 2.7.3 and 2.7.4, CSRs, and IBs.
- Strong understanding of regulatory medical writing principles, clinical development processes, and ICH E3 guidelines.
- Excellent scientific writing, editing, and proofreading skills with a focus on accuracy.
- Strong project management capabilities to coordinate multiple deliverables and stakeholders.
- Excellent client-facing and communication skills.
- Ability to work independently in a remote environment.
- Experience with safety aggregate reports, briefing books, ISEs, and ISSs is preferred.
Responsibilities
- Lead the preparation and delivery of clear, scientifically accurate, and regulatory-compliant medical writing deliverables.
- Develop and oversee documents including clinical study protocols, CSRs, patient narratives, investigator brochures, and informed consents.
- Lead writing activities for CTD Modules 2.7.3 and 2.7.4, ISE/ISS, and NDA/eCTD submissions.
- Coordinate medical writing activities across departments and manage document reviews.
- Review statistical analysis plans and table, figure, and listing specifications.
- Mentor less experienced medical writers and provide technical guidance.
- Monitor assigned project budgets and timelines.
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