Senior Medical Writer – Early Phase, Single Sponsor Support

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

📋 Description

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

• Manages medical writing tasks related to individual studies, coordinating activities within and across departments with minimal supervision.

• Takes the lead in addressing comments from the client.

• Produces a wide range of documents, including 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.

• 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, ensuring medical writing projects are completed on time and within budget.

• Coordinates quality and editorial reviews.

• Ensures proper management of source documentation.

• Leads team document reviews and evaluates documents as necessary.

• Serves as a peer reviewer for the internal team to verify scientific content, clarity, consistency, and correct formatting of documents.

• Assesses statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency.

• Provides feedback to clarify statistical output requirements and document needs.

• Cultivates positive working relationships with clients, department heads, and colleagues in data management, biostatistics, regulatory affairs, and medical affairs, as needed, to produce writing deliverables.

• Conducts online clinical literature searches while adhering to copyright regulations.

• Identifies and suggests solutions to resolve issues, escalating matters when necessary.

• Offers technical support, training, and consultation to the department and other company staff.

• May assist in the development of internal materials and presentations or adjustments to internal processes, standard practices, and capabilities.

• 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 impacting medical writing.

• Remains aware of budget constraints for assigned projects, working within allocated hours and communicating status and changes to medical writing leadership.

• Completes necessary administrative tasks within set timeframes.

• Performs additional work-related duties as assigned.

• Minimal travel may be required (less than 25%).

⛳️ Requirements

• 3-5 years of relevant experience in regulatory writing.

• Required experience in the biopharmaceutical, device, or contract research organization sectors.

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

• Experience in writing relevant document types is required.

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

🏝️ Benefits

• We are dedicated to the development of our employees through career advancement opportunities, supportive line management, technical and therapeutic area training, peer recognition, and a total rewards program.

• We are committed to fostering an inclusive culture where you can genuinely be yourself.