Principal Medical Writer (Regulatory Submissions)

JR Spain; Madrid; Presencial; EUR 45.000 - 75.000; Jornada completa

Descripción de la vacante

An established industry player is seeking a Principal Medical Writer to lead regulatory submissions and mentor junior writers in Madrid. This role involves overseeing the creation of clinical study protocols and reports while ensuring compliance with regulatory standards. The ideal candidate will possess a strong background in medical writing, excellent command of English grammar, and familiarity with FDA and ICH regulations. Join a dynamic team where your expertise will help shape the future of clinical research and contribute to impactful projects. If you are passionate about writing and science, this opportunity is perfect for you.

Formación

• Bachelor's degree with relevant writing and scientific knowledge.
• Extensive knowledge of English grammar and AMA style guide.

Responsabilidades

• Lead and mentor less experienced medical writers on complex projects.
• Develop and review documents including protocols, reports, and submissions.

Conocimientos

Medical Writing

Regulatory Submissions

English Grammar

Presentation Skills

Interpersonal Skills

Educación

Bachelor of Science or Arts

Descripción del empleo

Principal Medical Writer (Regulatory Submissions), Madrid

Client: Syneos - Clinical and Corporate - Prod

Location: Madrid, Spain

Job Category: Other

EU work permit required: Yes

Job Reference: 839989153621658828832460

Job Views: 2

Posted: 31.03.2025

Expiry Date: 15.05.2025

Job Description:

Role Overview: As a Principal Medical Writer at Syneos Health, you will lead medical writing activities related to regulatory submissions, including clinical study protocols, reports, and IND submissions. You will mentor less experienced writers, represent the Medical Writing department in various forums, and ensure compliance with regulatory standards.

Responsibilities:

1. Mentor and lead less experienced medical writers on complex projects.
2. Represent the Medical Writing department on clinical study teams and at conferences.
3. Advise clients and study teams on data presentation and production strategies.
4. Manage medical writing activities for individual studies, coordinating across departments.
5. Develop and review a variety of documents, including protocols, reports, and submissions.
6. Review statistical analysis plans and ensure quality and compliance.
7. Serve as peer reviewer to ensure clarity, accuracy, and adherence to standards.
8. Adhere to regulatory standards, SOPs, and templates.
9. Perform literature searches and maintain professional development.
10. Understand and work within budget specifications.
11. Complete administrative tasks timely. Minimal travel may be required.

Qualifications:

1. Bachelor of Science or Arts degree with relevant writing and scientific knowledge.
2. Extensive knowledge of English grammar and AMA style guide.
3. Understanding of FDA and ICH regulations preferred.
4. Effective presentation, proofreading, and interpersonal skills.
5. Familiarity with principles of clinical research and data interpretation.