Principal Medical Writer

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

📋 Description

• Conduct a thorough evaluation, analysis, and interpretation of medical literature to select primary resource materials that ensure appropriate study design, statistical significance, scientific rigor, and absence of bias.

• Draft and refine clinical development documents, which include, but are not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials, and publications for medical journals.

• Complete writing tasks within specified deadlines.

• Manage timelines and the workflow associated with writing assignments.

• Deliver excellent internal and external customer service.

• Demonstrate high proficiency in various writing styles for regulatory documents.

• Exhibit expert proficiency with client templates and style guides.

• Collaborate directly and independently with clients to oversee all aspects of projects; exhibit competent communication skills for project management.

• Make significant contributions to, or manage, the production of interpretive guides.

• Take ownership of assigned tasks, proactively seeking information or guidance from other project team members and departmental representatives when necessary.

• Provide mentorship to medical writers and other project team members involved in the writing process.

⛳️ Requirements

• A Bachelor’s, Master’s, or PhD Degree in a scientific, medical, clinical discipline, or a related field is required, along with a minimum of 6 years of prior regulatory writing experience; a Master’s or PhD degree is preferred.

• Significant experience in clinical study protocols as the lead author is essential.

• Proven ability in leading and managing teams while authoring regulatory documents under tight deadlines.

• Experience with regulatory submissions (clinical study reports) to regulatory authorities is advantageous.

• A solid understanding of clinical data is required.

• Exceptional writing skills are mandatory.

• Excellent organizational abilities and the capacity to multitask are essential prerequisites.

• Candidates must be proficient in MS Word, Excel, PowerPoint, and related word processing tools.

• Experience as a project lead or managing a project team is necessary.

• A strong grasp of federal regulations, Good Clinical Practices, and ICH guidelines is a plus.

• While not mandatory, experience with orphan drug designations and PSP/PIPs is a plus.

🏝️ Benefits

• Great Place to Work certified organization.

• Supportive and innovative team environment.

• Exceptional culture and industry-best employee retention rate.