Senior Medical Writing Manager Job at System One, Inc. in Plainsboro

Overview 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)
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.
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System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services 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 full-time 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.

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