Principal Medical Writer

Overview

Principal Medical Writer who leads complex medical writing deliverables and manages document strategy for individual studies, serving as a key technical subject matter expert and mentoring less experienced medical writers.

What you'll do

• Lead the clear and accurate completion of complex medical writing deliverables, ensuring scientific information is presented clearly and accurately.
• Manage medical writing activities associated with individual studies, defining document strategy and coordinating medical writing activities within and across departments with minimal supervision.
• Lead the resolution of comments from the client.
• Complete a variety of documents that may include clinical study protocols and amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; plain language summaries; periodic safety update reports; clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; and abstracts, posters, and presentations for scientific meetings.
• Adhere to established regulatory standards, including ICH E3 guidelines, as well as company standard operating procedures, client standards, approved templates, authorship requirements, and style and formatting guides, on time and on budget.
• Advise clients and study teams on data presentation and production strategies to ensure client objectives are met and quality standards are maintained.
• Lead team document reviews and review documents for technical issues; coordinate quality and editorial reviews and ensure source documentation is managed appropriately.
• Serve as expert peer reviewer for the internal team, providing review comments for clarity, accuracy, and relevance.
• Review statistical analysis plans and table, figure, and listing specifications for appropriate content, grammar, format, and consistency, and provide feedback to further define statistical output and document needs.
• Interact and build working relationships with clients, department heads, and team members in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables.
• Perform online clinical literature searches and comply with copyright requirements.
• Identify and propose solutions to resolve issues, escalating as appropriate; serve as a key technical SME and contribute to internal materials, presentations, process changes, and standard practices.
• Mentor and lead less experienced medical writers on complex documents.
• Develop deep expertise on key industry topics and the regulatory requirements and guidelines that affect medical writing; engage externally with industry groups on industry initiatives.
• Track budget specifications for assigned projects, communicate status and changes to medical writing leadership, negotiate timelines and deliverables, and contribute to bid projections.
• Represent the medical writing department on clinical study teams, at conferences, meetings, and client presentations regarding writing projects.
• Complete required administrative tasks within specified timeframes.
• Perform other work-related duties as assigned.

What you'll need

• Advanced degree in a scientific discipline (MS, PhD, PharmD, MD, or equivalent).
• Minimum 5 years of relevant experience within the pharmaceutical, biotechnology, medical communications, or consulting industries.
• Demonstrated experience leading publication planning, publication strategy, and publication execution programs.
• Proven track record developing and executing integrated publication plans across multiple studies and assets.
• Strong hands-on scientific writing and content development experience, including manuscripts, congress abstracts, posters, and presentations.
• Experience utilizing AI tools and technologies to support publication development.

Nice to have

• PhD or PharmD (strongly preferred).

Details

• Preferred location: U.S. East Coast.
• Minimal travel may be required (less than 25%).