[Hiring] Medical Writer - Regulatory Writing Specialist @Med Communications International

Role Description

The Regulatory Writing Associate is a professional responsible for the creation of regulatory materials for investigational and marketed products in alignment with regulatory and compliance practices. The individual will work under the guidance of a manager or trainer to support regulatory writing projects.

Essential Functions

• With support, serve as lead writer on regulatory documents (e.g., protocols, CSRs, IB updates).
• Manage timelines and communications for writing projects.
• With support, organize and lead document review meetings with cross-functional teams, clarify and incorporate feedback.
• Ensure clarity, consistency, and accuracy across all assigned deliverables.
• Perform document-level quality control review (including abbreviations, references to sources, data in text versus data in tables, figures, or graphs, etc.) and contribute to peer reviews (logical flow, sense check etc.).
• Collaborate with subject matter experts to resolve feedback and align messaging.
• Understand and comply with SOPs, templates, best practices, policies, and regulatory writing style guides.
• Develop project-level lexicons and conventions.

Qualifications

• Above average attention to detail, teamwork, and initiative.
• Ability to interact with other departments within the company and be proficient in written and verbal communication.
• Proficient in Microsoft Word, PowerPoint, and Outlook, and quickly able to learn new software.
• Ability to apply regulatory guidelines to content development.
• Self-Motivated - Ability to be internally inspired to perform a task to the best of one's ability using his or her own drive or initiative.

Requirements

• Education: Advanced degree in a scientific discipline (e.g., life sciences, pharmacy, medicine) or relevant work experience; or equivalent combination of education, training, and experience.
• Experience: Up to 1 year of related experience in scientific/medical/regulatory writing in the pharmaceutical domain.
• Computer Skills: Proficiency with Microsoft Word, PowerPoint, and Outlook.

Work Environment

• Remote or Lisbon office, Portugal.