Medical Writing Science Senior Manager Vertex · Boston, MA Posted yesterday

QuickCruit, Inc.; Boston (MA); Hybrid; USD 137,000 - 206,000; Full time

Benefits offered by this job

Hybrid work model

Boston office-based

Job summary

QuickCruit, Inc. in Boston, MA seeks a Medical Writing Science Senior Manager to author complex clinical study documents and contribute to regulatory submissions across all development phases.

You will lead cross-functional teams, review study-level documents, shape regulatory strategy, and support advisory committee presentations, with a hybrid schedule of two remote days.

Qualifications

• Outstanding written and oral communication skills.
• Extensive experience writing and editing clinical regulatory documents.
• Ability to analyze, interpret, and summarize highly complex data.

Responsibilities

• Author complex clinical regulatory documents (protocols, CRFs, SARs, IBs, regulatory meeting documents) with stakeholders.
• Lead Medical Writing Scientist for pivotal studies across programs/therapeutic areas.
• Provide expert review of study-level documents and contribute to regulatory strategy and messaging.

Skills

Written and spoken communication

Clinical regulatory writing

Data interpretation & summarization

Job description

# Medical Writing Science Senior ManagerVertex · Boston, MATailor My ResumeStart free. No credit card.### About the roleThe Medical Writing Science Senior Manager is responsible for independently authoring complex clinical study documents and sections of regulatory submissions to support all phases of clinical drug development. This role may represent Medical Writing Science as a cross-functional team member for study-level and program-level activities.This is a hybrid role which allows for 2 days per week remote work and 3 days per week in the Boston Fan Pier office.### Responsibilities* Authors complex clinical regulatory documents (e.g., clinical study protocols, clinical study reports, investigator’s brochures, documents to support meetings with regulatory agencies, and sections of marketing authorization applications) in partnership with key stakeholders* Serves as the lead Medical Writing Scientist for complex or pivotal clinical studies for multiple programs or therapeutic areas* Provides expert review of study-level and program-level documents* Participates in developing key messages for complex clinical regulatory documents* Provides leadership on teams responsible for defining the direction and regulatory strategy for a clinical development program* Provides strategic and scientific contributions to regulatory documentation in support of the clinical development pipeline* Contributes to content and strategy of presentations for regulatory agency advisory committee meetings; may prepare advisory committee briefing documents* Ensures document preparation is compliant with company and industry standards* Strong contributor on cross-functional teams working on standard operating procedures, process improvements, and integration of new tools and technologies### Qualifications* Outstanding written and oral communication skills* Extensive experience writing and editing clinical regulatory documents* Ability to analyze, interpret, and summarize highly complex data* Advanced understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminologyPosted2 days agoJob TypeFull-timeSalary$137,200 – $205,800 USDLocation* Boston, MA