The Medical Writer is responsible for authoring, reviewing, and coordinating the development of high-quality clinical and regulatory documents that support global clinical development programs.
Compensation
The hourly rate for this position is between $XX-XX per hour.
Responsibilities
Author, edit, and review clinical and regulatory documents, including Clinical study protocols and protocol amendments, Investigator Brochures (IBs), Clinical Study Reports (CSRs), Briefing Book support, IND and NDA summary documents and other regulatory submission materials
Develop documents that are consistent with regulatory requirements, internal standards, and medical writing plans, while supporting the overall clinical development lifecycle and program objectives for one or more clinical development programs
Collaborate with cross-functional teams, including Clinical Development, Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Pharmacovigilance, and Medical Affairs, to gather, interpret, and integrate scientific and clinical information into clear, accurate, and submission-ready documents
Negotiate document deliverable milestones and timelines with cross-functional teams to ensure alignment across functions and adherence to medical writing plans and program objectives
Facilitate document review cycles, resolve reviewer comments, and drive consensus among stakeholders while maintaining quality and schedule commitments
Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. Leads the resolution of comments from the client.
Compensation
Salary Range:
$70,100.00 - $145,000.00
Responsibilities
Leads the clear and accurate completion of medical writing deliverables
Manages medical writing activities associated with individual studies
Completes clinical study protocols, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, NDA and eCTD submissions, journal manuscripts, and abstracts/posters
Adheres to established regulatory standards (ICH E3 guidelines, SOPs, client standards)
Support global clinical development programs through the hands-on authoring, editing, and review of clinical and regulatory documents.
Compensation
$95-110.73/hr
Responsibilities
Author and review clinical and regulatory documents, including clinical study protocols, protocol amendments, Clinical Study Reports (CSRs), Investigator Brochures (IBs), briefing books, and IND/NDA submission materials.
Collaborate with Clinical Development, Clinical Operations, Biostatistics, Regulatory Affairs, Pharmacovigilance, and other cross-functional teams.
Coordinate document review cycles, incorporate stakeholder feedback, and ensure deliverables meet established timelines.
Ensure documentation aligns with applicable regulatory requirements, ICH guidelines, Good Clinical Practice (GCP), and internal standards.
Develop high-quality complex clinical and regulatory documents from planning and coordination through to final delivery, ensuring they meet all regulatory requirements and company standards.
Responsibilities
Researches, writes, and edits clinical study reports and study protocols, and summarizes data from clinical studies
May serve as primary author who writes and provides input on complex clinical and scientific and program level documents, including IBs, INDs, and MAAs
Provides senior level review of routine and complex documents
Provides training and mentorship for other writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge
Ensures compliance with quality processes and requirements for assigned documents
Requirements
Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification
Lead and deliver high‑quality medical writing for complex clinical and regulatory projects.
Responsibilities
Lead authoring and strategic planning for clinical and regulatory documents, including protocols, clinical study reports, briefing documents, and submission dossiers.
Manage end‑to‑end writing projects, coordinating contributors, timelines, and quality checks to meet regulatory and internal standards.
Translate complex clinical and statistical data into clear, accurate, and well‑structured scientific narratives for diverse audiences.
Act as a subject matter expert on medical writing standards, document structure, and regulatory expectations.
Drive process improvement initiatives, support KPI tracking, and contribute to audit readiness and compliance activities.
Requirements
Bachelor’s degree in life sciences, health sciences, or a scientific field
Nice to have: Advanced degree (PhD, PharmD, MPH, MS)
Nice to have: Experience leading regulatory submission projects
Nice to have: Statistical concepts
Nice to have: Multicultural or remote team settings
Provide end-to-end regulatory support for pharmaceutical and biotechnology development and commercialization programs, including IND/NDA submission management, lifecycle maintenance, health authority interactions, and regulatory intelligence.
Compensation
We offer competitive compensation and a comprehensive benefits package to eligible employees, including paid time off, a 401(k) match, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans. Some roles may also be eligible for additional incentives, bonuses, or other compensation programs.
Responsibilities
Lead or support IND and NDA submission management
Maintain detailed tables of contents and submission trackers
Coordinate with regulatory publishing and document management
Draft and coordinate FDA forms and supporting documentation
Support major regulatory submissions
Requirements
Bachelor’s degree in a scientific, technical, or related discipline required; advanced degree preferred
The Senior Medical Writer - Safety Focus is a major contributor to document authorship for a variety of aggregate safety reports within the safety service line, acting as project lead on smaller projects and supporting larger, more complex engagements.
Responsibilities
Document authorship for a variety of aggregate safety reports
Project lead on smaller projects, interfacing directly with the client
Support larger, more complex engagements as a member of a larger delivery team
The Principal Medical Writer independently plans and prepares regulatory documents and medical communications to support all phases of product development.
Compensation
The estimated hiring range for this role is $132K to $151K plus applicable bonus. This hiring range is specific to the US and will vary for other regions based upon local market data.
Responsibilities
Plan and prepare regulatory documents and medical communications
Organize, analyze, interpret, and present scientific and statistical information
Collaborate with cross‑functional internal and external document production teams
Lead internal project teams and anticipate regulatory effects of writing practices
Develop submission‑level documents and provide subject‑matter guidance
Write copy for resort and gaming brands, including scripts, headlines, and multi-format copy across TV, radio, OOH, print, digital, and experiential channels.
Responsibilities
Concept integrated campaigns with art director partner
Develop platforms and campaign lines across placements
Pressure-test ideas against brief and brand
Write broadcast and streaming scripts, radio, OOH, print, digital display, paid and organic social, web, on-property and experiential copy
Medical Writer - Senior Regulatory Writing SpecialistNewMed Communications, Inc. · Remote, Italy