Principal Medical Writer – Publications

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the precise and timely completion of intricate medical writing assignments.

• Manage medical writing processes for individual studies, outlining document strategies, and coordinating efforts across various departments.

• Lead the resolution of client feedback.

• Produce documents for clinical, regulatory, safety, publication, and scientific meetings, such as protocols, clinical study reports, investigator brochures, informed consents, submissions, manuscripts, abstracts, posters, and presentations.

• Implement regulatory standards, company SOPs, client specifications, templates, authorship requirements, and style guides.

• Provide guidance to clients and study teams regarding data presentation and production techniques.

• Facilitate document reviews and manage quality and editorial evaluations.

• Act as a subject matter expert in peer reviews, evaluating statistical analysis plans and table/figure/listing specifications.

• Cultivate professional relationships with clients and teams in data management, biostatistics, regulatory affairs, and medical affairs.

• Conduct online searches of clinical literature and adhere to copyright regulations.

• Identify and address issues, act as a technical expert, and contribute to internal resources and process enhancements.

• Mentor and guide less experienced medical writers.

• Enhance knowledge in industry topics and regulatory standards while engaging with industry organizations.

• Monitor project budgets, assist in bid forecasts, communicate project statuses, and negotiate timelines.

• Represent the medical writing team on clinical study groups, at conferences, meetings, and during client presentations.

• Complete administrative responsibilities and other assigned tasks.

⛳️ Requirements

• Proven experience and extensive knowledge in medical writing and clinical study documentation.

• Capability to deliver clear, precise, and complex medical writing outputs.

• Familiarity with ICH E3 guidelines and relevant regulatory standards.

• Ability to adhere to SOPs, client standards, approved templates, authorship requirements, and style and formatting guidelines.

• Experience in reviewing statistical analysis plans and table/figure/listing specifications.

• Proficient in conducting online clinical literature searches and complying with copyright laws.

• Skilled in advising clients and study teams on data presentation and production methodologies.

• Competent in leading document, quality, editorial, and peer reviews.

• Ability to identify, suggest, and escalate solutions for issues encountered.

• Capable of mentoring less experienced medical writers.

• Proficient in managing budgets, timelines, and deliverables.

• Some travel may be necessary (less than 25%).

• Equivalent experience, skills, and/or education will also be taken into account.

🏝️ Benefits

• Opportunities for career advancement and growth.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• An inclusive company culture.

• Provision of a company car or car allowance.

• Comprehensive Medical, Dental, and Vision health benefits.

• Company-matched 401k contributions.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Potential to earn commissions or bonuses based on individual and company performance.

• Flexible paid time off (PTO).

• Sick leave.

• Reasonable accommodations provided when appropriate.