Medical Writer II – Publications

This is a fully remote position, open to applicants in Arizona, +3 more states.

📋 Description

• Guides the precise and thorough completion of medical writing deliverables, ensuring that scientific information is conveyed clearly and accurately.

• Oversees medical writing tasks related to individual studies, coordinating writing efforts within and across departments with minimal oversight.

• Produces a variety of documents, which may include clinical study protocols and their 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 conferences.

• Complies with established regulatory standards, including but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved templates, authorship requirements, and style and formatting guides, delivering medical writing projects on time and within budget.

• Organizes quality and editorial reviews.

• Ensures that source documentation is appropriately managed.

• Serves as a peer reviewer for the internal team to validate document scientific content, clarity, overall consistency, and correct format.

• Provides insights to further clarify statistical output requirements and document needs.

• Engages and fosters positive relationships with clients, department heads, and colleagues in data management, biostatistics, regulatory affairs, and medical affairs, as required, to deliver writing outputs.

• Mentors and guides less experienced medical writers on complex projects, as needed.

• Develops in-depth expertise on key industry topics and the regulatory requirements and guidelines influencing medical writing.

⛳️ Requirements

• 3-5 years of relevant experience in scientific, technical, or medical writing

• Experience in the biopharmaceutical, device, or contract research organization industry is required

• Strong knowledge of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices is essential

• Experience in writing relevant document types is mandatory

• Extensive knowledge of English grammar and the ability to communicate clearly; strong familiarity with the AMA Manual of Style

🏝️ Benefits

• Health benefits including Medical, Dental, and Vision

• Company-matched 401k

• Eligibility to participate in the Employee Stock Purchase Plan

• Opportunity to earn commissions/bonuses based on company and individual performance

• Flexible paid time off (PTO) and sick leave