Medical Writer

Updated: Today

Location: Barcelona, Spain

Job :

Medical writer on clinical study or regulatory project teams. Writes, edits, and coordinates content for clinical/regulatory documents to ensure high-quality completion of all assigned writing projects.

• Compiles, writes, edits, and coordinates medical writing deliverables that present scientific information clearly and accurately, and works as a medical writer within and across departments with moderate supervision.
• Completes a variety of documents that may include clinical study protocols and protocol amendments; clinical study reports; patient narratives; and investigator brochures.
• Adheres to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, company and/or client-approved templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget.
• Coordinates quality and editorial reviews. Ensures source documentation is managed appropriately. Leads document reviews, reviews documents as needed, and resolves comments from client.
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content and for grammar, format, and consistency.
• Interacts and builds good working relationships with clients, department head, and peers, as necessary, to produce writing deliverables.
• Performs online clinical literature searches and complies with copyright requirements.
• Identifies and proposes solutions to resolve document issues, escalating as appropriate.
• Continues professional development to grow awareness of industry standards and best practices to improve ability to meet client expectations.
• Aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to medical writing leadership.
• Completes required administrative tasks within the specified time frames.
• Performs other work‑related duties as assigned.
• Minimal travel may be required (less than 25%).

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion, and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.

Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed to brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to recruitment and employment of its employees.

The Company is committed to compliance with the Americans with Disabilities Act, including provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.