Senior Medical Writer

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

📋 Description

• Conduct critical evaluations, analyses, and interpretations of medical literature to identify primary resource materials for effective study design.

• Draft and revise clinical development documents, which may include clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, as well as Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials, and publications aimed at medical journals.

• Complete writing tasks within specified deadlines.

• Manage timelines and workflows associated with writing assignments.

• Uphold excellent internal and external customer service standards.

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

• Engage directly and independently with clients to coordinate all aspects of projects.

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

⛳️ Requirements

• A minimum of 3 years of prior experience in the pharmaceutical industry.

• Must possess at least 3-5 years of experience in industry regulatory writing and clinical medical writing.

• The ideal candidate should have a Bachelor’s, Master’s, or Ph.D. in a scientific, medical, or clinical discipline.

• Significant experience as the lead author of clinical study protocols is required.

• Proven experience 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 essential.

• Outstanding writing skills are mandatory.

• Excellent organizational abilities and multitasking skills are critical prerequisites.

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

• Experience in a project lead role or managing a project team is preferred.

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

• Although not required, familiarity with orphan drug designations and PSP/PIPs is beneficial.

🏝️ Benefits

• Innovative, data-focused Contract Research Organization (CRO).

• Global presence spanning four continents.

• High-quality service and advanced technology solutions.