Senior Medical Writing Manager

Job Title: Senior Medical Writing Manager
Location: Plainsboro, NJ
Type: Contract
Work Model: Hybrid
Hours: Monday-Friday, 9:00 AM - 5:00 PM (40 hours per week)

Overview

Responsibilities

• Author and finalize complex clinical and regulatory documents including: Clinical Trial Protocols and Amendments
• Clinical Study Reports (CSRs)
• Investigator's Brochures (IBs)
• Clinical Overviews and Clinical Summaries
• Health Authority Briefing Packages and Responses
• CTD/eCTD submission documents
• Draft scientific publications including abstracts, posters, manuscripts, and slide presentations.
• Ensure documents meet quality standards and regulatory requirements.
• Serve as lead medical writer for assigned compounds and studies.
• Represent Medical Writing on Clinical Trial Teams and regulatory submission teams.
• Manage timelines, document review cycles, stakeholder feedback, and approval processes.
• Facilitate cross-functional collaboration to ensure timely submission readiness.
• Contribute to and lead development of templates, standards, and medical writing processes.
• Support continuous improvement initiatives and knowledge-sharing activities.
• Promote consistency and quality across global medical writing deliverables.
• Maintain expertise in ICH guidelines and global regulatory requirements.
• Ensure compliance with company SOPs, regulatory standards, and industry best practices.

Requirements

• 6-8+ years of medical writing experience within the pharmaceutical or biotechnology industry.
• Strong experience independently authoring: Clinical Trial Protocols
• CSRs
• Investigator's Brochures
• Clinical Summaries/Overviews
• Briefing Documents
• Health Authority Responses
• Extensive knowledge of: CTD/eCTD structure
• Clinical development processes
• Global regulatory requirements
• ICH Guidelines
• Experience leading regulatory submission writing activities.
• Strong project management and stakeholder management skills.
• Ability to interpret complex scientific and clinical data and communicate it effectively to regulatory audiences.
• Experience developing writing templates, standards, and process improvements.
• Able to work a hybrid schedule of 2-3 days onsite weekly in Plainsboro, NJ.

System One, and its subsidiaries including Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

#LI- Ref: #558-Scientific