Senior/Principal Medical Writer

📋 Description

• Create a range of clinical regulatory documents (including Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in CTD format, Investigator Brochures, IMPDs/INDs, and scientific publications) as the lead writer in collaboration with client authoring team members, supported by other writers as necessary.

• Ensure timely production of all documents in accordance with agreed schedules.

• Oversee and manage project budgets effectively.

• Comply with relevant SOPs and fulfill the requirements of Trilogy as well as the company’s clients.

• Provide document-specific guidance to clients.

• Supervise and coordinate the efforts of other writers and QC specialists involved with documents under your purview.

• Manage the timelines and review processes of your documents diligently.

• Operate within the client’s regulatory document management systems.

⛳️ Requirements

• Several years of professional experience in actively authoring regulatory documents.

• Experience as the lead writer on more than 3 (Senior Medical Writer) or more than 5 (Principal Medical Writer) of at least 3 of the following: Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in CTD format, Investigator Brochures, IMPDs/INDs, and scientific publications.

• For the Principal Medical Writer role, experience with at least 2 different types of CTD dossiers (e.g., full new chemical entity application, variation, generic dossier, orphan drug dossier, literature-based dossier such as a full-mixed application under Article 8(3) of Directive 2001/83/EC).

• Proven experience in direct interactions with clients or authors of the documents, coordinating review cycles, meetings, and project timelines.

• For the Principal Medical Writer position, a willingness and ability to take on any project requiring a Lead Writer.

• Proficiency in utilizing document management systems and review tools.

• Diploma/Masters/Bachelor’s degree in science/pharmacy (Ph.D. not required).

• Fluent in written and spoken English.

• A keen appreciation for well-crafted documents and strong attention to detail.

• Excellent interpersonal skills with a proactive approach to teamwork among diverse personalities.

• Adaptability and the ability to maintain focus under tight deadlines.

• Must reside in the UK, Germany, Italy, Ireland, or Portugal.

🏝️ Benefits

• Standard Trilogy benefits.