Job Title

Medical Writing Operations Consultant (Protocols & Clinical Reports) Location:Remote / Hybrid (India preferred, open globally) Engagement:Contract / Fractional Consultant (3–6 months, extendable) Start:ImmediateAbout MS Clinical Research MS Clinical Research (MSCR) is a fast-growing clinical research organization conducting dermatology and cosmetic clinical trials across India and internationally. We are building scalable, standardized clinical documentation systems to support our growth.Role Objective We are seeking an experiencedMedical Writing Operations Consultantto streamline and standardize protocol and report development workflows. This is not a pure writing role — the focus is ontemplate governance, operational efficiency, and scalable document systems .Key Responsibilities 1. Protocol & Report Template Standardization Redesign and implement master templates for: Clinical trial protocols Final study reports / CSRs Amendments, synopses, and appendices Build modular, reusable content blocks across studies 2. Medical Writing Workflow Optimization Develop an efficient end-to-end document workflow: Draft → QC → Medical review → Sponsor-ready final Reduce turnaround times and review burden 3. Quality Control & Consistency Create document QC checklists and style standards Ensure alignment with ICH-GCP and sponsor expectations Improve consistency across writers and projects 4. Training & Knowledge Transfer Train internal writers and managers on: Template usage Writing standards Review best practices Deliver a sustainable system, not consultant dependency Required Qualifications 10+ years of experience inCRO medical writing Strong expertise in: ICH E3 (Clinical Study Reports) ICH E6 (Protocols / GCP documentation) Proven experience building: Protocol/CSR template libraries Writing SOPs or governance frameworks Experience leading or mentoring medical writing teamsPreferred Experience Dermatology, cosmetic, or medical device clinical trials Prior work in CRO environments with experience in structuring a team of 5-10 people.Engagement & Deliverables Template overhaul + writing playbook within first 8–12 weeks Workflow + QC framework implementation Ongoing fractional oversight optional