Principal/Associate Principal Medical Writer

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

📋 Description

• Serve as the primary writer responsible for creating clinical regulatory documents, such as Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, and scientific publications.

• Collaborate with client authoring teams and other writers to ensure cohesive document development.

• Guarantee that documents are completed within established timelines, oversee and manage project budgets, comply with relevant SOPs, and fulfill Trilogy and client expectations.

• Offer document-specific guidance to clients as needed.

• Supervise and coordinate the efforts of writers and QC specialists involved with assigned documents.

• Manage project timelines and review cycles for document preparation.

• Operate within clients’ regulatory document management systems.

⛳️ Requirements

• A minimum of 5 years of experience in actively writing regulatory documents.

• Lead writer experience on CTD documents is essential.

• Proven track record as a lead writer for Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, and scientific publications.

• Experience managing multiple-document projects with global, multinational teams, including team leadership, project oversight, review management, and budget supervision.

• Capability to handle several projects concurrently.

• Comprehensive knowledge of relevant regulatory guidelines, including ICH, FDA, and EMA standards for clinical trial execution.

• Background in various therapeutic areas.

• Advanced comprehension of statistical, regulatory, and medical communication principles.

• Proficiency in using document management systems and review tools.

• Bachelor’s degree in science or pharmacy is required; a Ph.D. is not necessary.

• Fluent in written and spoken English.

• Strong appreciation for well-crafted documents and meticulous attention to detail.

• Excellent interpersonal skills with a proven record.

• Ability to adapt and maintain focus under tight deadlines.

🏝️ Benefits

• Competitive base salary.

• Opportunity for annual bonuses.

• A generous allocation of paid time off.

• Comprehensive benefit plans tailored to your region.

• Full EMWA membership and coverage for annual conference attendance provided by Trilogy.

• Ongoing personal and professional development opportunities.

• Complimentary weekly yoga sessions.

• Additional fun and engaging events that promote team bonding and growth.