Principal Medical Writer
Location: United States
Job Category: Medical Writing
Time Type: Full-time
Posted on: 8 Days Ago
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About ProPharma:
ProPharma is dedicated to advancing patient health and wellness, offering consulting solutions for biotech, med device, and pharmaceutical organizations. Our mission is to help our partners accelerate high-profile drug and device programs while ensuring compliance with industry standards, leveraging over 20 years of expertise in regulatory sciences, clinical research, and medical writing.
Position Overview:
The Principal Medical Writer will take a lead role in managing clinical program documents, including protocols, study reports, regulatory submissions, and more. This role demands advanced writing skills, cross-functional coordination, and the ability to mentor junior writers while ensuring compliance with regulatory standards and client expectations.
Key Responsibilities:
Lead communication on project-related matters with medical writing leadership and internal teams.
Manage the creation of complex clinical and regulatory documents (e.g., protocols, study reports, PBRER, IND, NDA, BLA, MAA, eCTD submission documents).
Coordinate resources and manage medical writing and QC deliverables across internal and external teams.
Independently write, edit, and finalize high-quality documents for clinical, safety, regulatory, and device/diagnostic-related projects.
Supervise, train, and mentor less experienced medical writers.
Ensure all documents comply with regulatory standards, including ICH E3, EU MDR/IVDR, and client-specific templates.
Manage timelines, budgets, and client expectations, and communicate effectively with clients during meetings.
Collaborate with subject matter experts in clinical operations, data management, and biostatistics to deliver accurate and complete documents.
Conduct QC reviews of documents and maintain detailed audit trails of changes.
Lead and perform peer reviews of documents written by other medical writers.
Assist with administrative tasks related to projects, including timelines and deliverable trackers.
Stay up-to-date with industry best practices, regulatory requirements, and medical writing guidelines.
Support multiple projects simultaneously, ensuring efficient time management.
Qualifications:
Educational Requirements:
Bachelor’s degree or higher, preferably in a medical or scientific discipline.
Experience Requirements:
Minimum of 7 years of experience writing clinical and/or regulatory documents in the pharmaceutical, biotech, or CRO industry.
Necessary Skills and Abilities:
In-depth knowledge of clinical research principles and regulatory requirements.
Proficiency in MS Word, including tables, graphs, and figures.
Strong project management and communication skills.
Experience with FDA and other regulatory bodies’ submission processes.
Ability to think proactively, manage multiple projects, and work independently.
Workplace Commitment:
ProPharma values diversity, equity, and inclusion, offering a supportive environment where each employee can thrive. We encourage innovation, collaboration, and entrepreneurial thinking, providing a safe space where everyone is empowered to succeed.
Additional Information:
ProPharma does not accept unsolicited resumes from recruiters or third-party agencies.
No phone calls or emails regarding this posting, please.
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