Senior/Principal Medical Writer

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

📋 Description

• Compose clinical regulatory documents such as Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in CTD format, Investigator Brochures, IMPDs/INDs, and scientific publications, serving as the lead writer.

• Collaborate with client authoring teams and fellow writers.

• Ensure that documents adhere to established timelines, project budgets, SOPs, Trilogy standards, and client specifications.

• Offer document-specific guidance to clients.

• Supervise and coordinate the efforts of writers and QC specialists.

• Manage project timelines and review processes for documents.

• Operate within clients’ regulatory document management systems.

⛳️ Requirements

• Several years of professional experience in writing regulatory documents.

• Senior Medical Writer: has served as the lead writer on more than 3 documents across at least 3 specified document types.

• Principal Medical Writer: has led more than 5 documents across at least 3 specified document types.

• Principal Medical Writer: possesses experience with at least 2 different types of CTD dossiers.

• Experience in direct interactions with clients or document authors.

• Proven experience in coordinating review cycles, meetings, and project timelines.

• Principal Medical Writer: demonstrates the ability and willingness to undertake any project requiring a Lead Writer.

• Proficient in using document management systems and review tools.

• Holds a Diploma, Master’s, or Bachelor’s degree in science or pharmacy; a Ph.D. is not required.

• Fluent in written and spoken English.

• Values well-crafted documents and exhibits strong attention to detail.

• Excellent and proven interpersonal communication skills.

• Ability to adapt and maintain focus under tight deadlines.

• Must be eligible to work in Ireland.

• Must reside in Ireland.

• Freelancers are not encouraged to apply.

• Candidates should submit a cover letter detailing compliance with the stated experience requirements along with a CV.

🏝️ Benefits

• Standard Trilogy benefits.

• A supportive environment that encourages growth, flourishing, and optimal performance.

• Commitment to equal employment opportunities and non-discrimination.