FSP Medical Writer (NA)

Thermo Fisher Scientific • Morrisville, NC

9d • Onsite

About The Position

This requirement is within Biogen FSP. The Medical Writer provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. The role involves collaborating with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence. What You'll Do: Serve as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, and summarizes data from clinical studies. May assist with more complex clinical and scientific and program level documents, including IBs, INDs, and MAAs. Ensure compliance with quality processes and requirements for assigned documents. May assist in determining best practices, methods and techniques for achieving optimal results. May assist in program management activities. Duties could include assisting with developing timelines, budgets, and forecasts for assigned deliverables. Represent the department at project launch meetings, review meetings, and project team meetings.

Requirements

• Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
• Solid medical writing skills, including grammatical, editorial, and proofreading skills
• Ability to interpret and present complex data accurately and concisely
• Effective administrative, organizational and planning skills; attention to detail and quality
• Ability to work on own initiative and effectively within a team
• Effective oral and written communication skills
• Good knowledge of regulatory documentation and drug development process
• Great judgment and decision-making skills
• Good computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)

Nice To Haves

• Experience in neurology preferred.
• Experience working in the pharmaceutical/CRO industry preferred
• Experience in scientific writing advantageous

Responsibilities

• Serve as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, and summarizes data from clinical studies.
• May assist with more complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
• Ensure compliance with quality processes and requirements for assigned documents. May assist in determining best practices, methods and techniques for achieving optimal results.
• May assist in program management activities. Duties could include assisting with developing timelines, budgets, and forecasts for assigned deliverables.
• Represent the department at project launch meetings, review meetings, and project team meetings.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees