Principal Medical Writer

Job Overview

Responsible for preparation and coordination of complex clinical study protocols and clinical study reports (CSRs), and other documents as needed. Responsible for preparation of submission level documents. Provide review and feedback on documents prepared by the department. Performs the scientific review of clinical study outlines, protocols, statistical analysis plans, tables, figures and listings, and CSRs, ensuring high scientific integrity and correct data interpretation where applicable for all of these products. Act as leader of Medical Writing team on large-scale (multiple document) writing projects, as appropriate. Production of scientific publications and other documents (e.g., abstracts, posters, manuscripts, etc.). Provides technical leadership with responsibility for delivering Medical Writing Services to clients and internal Fortrea project teams. Ensure timely delivery of high-quality documents to internal customers and Sponsors. Scientific presentations both internally within Fortrea and externally (e.g., conferences). Represents the company at scientific meetings and meetings with clients. Works with the management team to provide project leadership, guidance, mentoring and training to Medical Writers to ensure best working practices are maintained. Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time. Medical Writers in the Early Clinical Services Medical Writing (MW) group would typically work on clinical documents for studies in the early phases of clinical development (e.g., Phase I through IIa studies focused on pharmacokinetics and pharmacodynamics). Medical Writers in the Late Stage MW group would typically work on clinical documents for studies in later stage of clinical development (e.g., Phase II through IV studies focused on efficacy and safety). The activities described below are to be considered in the context of the MW group in which the MW position is located.

Summary Of Responsibilities

• Write and coordinate the development of protocols, CSRs, ICF, ORSR, IB update and CTD module 2 documents or other clinical documents of any complexity.
• Takes the lead in preparing submission level documents.
• Act as leader of Medical Writing team on large-scale (multiple document) writing projects, as appropriate, with support from management. Influence teams to adhere to the relevant medical writing requirements for projects.
• Produces scientific papers, abstracts and/or posters, and presentations.
• Effectively manage multiple assignments in parallel, ensuring adherence to quality, timelines, and budget requirements.
• Prepare documents in accordance with Fortrea/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines.
• Act as medical writing lead and liaison for major clients and partners.
• Represent company at scientific and medical writing forums.
• Keep up to date with developments in Medical Writing.
• Demonstrate detailed knowledge of Medical Writing industry requirements such as ICH and regulatory agency guidelines.
• To regularly demonstrate initiative and ability to deal with medical writing situations independently. Present solutions and convince management and teams to adopt recommended strategies.
• Lead Medical Writing initiatives to develop and improve processes, including new technologies. Persuade other department staff to accept and embrace new working practices.
• Mentor staff and provide guidance and training to department.
• Provide support for Business Development opportunities such as time and cost estimates, attendance at client bid defense meetings, industry conferences.
• Write and review Fortrea SOPs and associated documents.
• Represent department in audits and inter-department working groups.
• Comply with Fortrea internal processes and procedures.
• Performs other duties as assigned by Management.
  
  

Qualifications (Minimum Required)

• Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred.
  
  

Experience (Minimum Required)

• Typically, minimum 8+ years medical writing experience, including 3 years as medical writing project lead.
• Excellent command of written and spoken English.
• Excellent written and verbal communication skills.
• In-depth knowledge of MS Word.
• Excellent organizational and time management ability.
• Excellent knowledge of ICH guidelines applicable to medical writing and other regulatory guidance.
• Excellent understanding of medical/scientific terminology, data analysis and interpretation.
• Appreciation of the business requirements of a contract research organization.
  
  

Physical Demands/Work Environment

• % of time dedicated to travel 5%.
• % of the above that requires overnight stay 50%.
• Travel is primarily to where, variable.
• Office environment.
• Regularly required to sit.
• Overtime and weekend work as required.
  
  

Learn more about our EEO & Accommodations request here.