Job Description

Senior Medical Writer - Contract - Basking Ridge, NJ

We are on the hunt for bold, innovative thinkers who are ready to help push the boundaries of science and make a tangible difference in the world.

Proclinical is seeking a Senior Medical Writer to join our client's team in Basking Ridge, NJ.

Primary Responsibilities:

The successful candidate will be responsible for crafting clinical documents such as CSRs, protocols, ICFs, narratives, and IBs across various therapeutic areas, with a focus on oncology. You will have the opportunity to contribute to regulatory documents and lead projects, ensuring compliance with regulatory guidelines and document standards.

Skills & Requirements:

• Strong understanding of the clinical research process and relevant regulations/guidelines.
• Experience in reading, writing, and editing clinical documents.
• Excellent organizational, interpersonal, and communication skills.
• Proficiency in MS Word, Adobe Acrobat, PowerPoint, and electronic document management systems.
• Ability to manage multiple projects effectively.
• Familiarity with ICH GCP guidelines.
• Bachelor's degree required; advanced degree preferred.
• Relevant medical writing experience, including knowledge of biostatistics.

The Senior Medical Writer's responsibilities will be:

• Collaborate with clinical teams to develop content for clinical documents including CSRs, protocols, ICFs, narratives, and IBs.
• Represent medical writing at meetings and drive document development discussions.
• Participate in process improvement initiatives and working groups within medical writing and global development.
• Manage processes, organize priorities, solve problems, and foster collaboration.
• Review work of junior and outsourced medical writers.
• Evaluate CSR-related documents like Statistical Analysis Plans and TFLs for appropriate content.
• Write in plain language style for documents intended for lay or patient audiences, explaining complex medical/scientific concepts.

If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at [email protected]

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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