Senior Medical Writer/Principal Medical Writer - Regulatory Writing

Thermo Fisher Scientific • Morrisville, NC

1d • Onsite

About The Position

The Senior Medical Writer provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients and demonstrates subject matter and therapeutic area expertise. The Senior Medical Writer may assist program manager. The role involves collaborating with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.

Requirements

• Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
• Experience working in the pharmaceutical/CRO industry preferred
• Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
• Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
• Strong project management skills
• Excellent interpersonal skills including problem solving
• Strong negotiation skills
• Excellent oral and written communication skills with strong presentation skills
• Significant knowledge of global, regional, national and other document development guidelines
• In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
• Great judgment and decision-making skills
• Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)

Nice To Haves

• In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

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 research, write or edit complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
• Review routine documents prepared by junior team members. May provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge.
• Ensure compliance with quality processes and requirements for assigned documents. Provide input on and independently develops best practices, methods and techniques for achieving optimal results, including various client specific processes.
• May assist in program management activities. Identify and resolve out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications.
• Represent the department at project launch meetings, review meetings, and project team meetings.

Benefits

• Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior