MedFocus Medical Writer IV in United States

Job Description: A Medical Writer IV (Clinical Regulatory) is needed for a contract position at major pharma company in New England area.

The purpose of this job is to create, without supervision, any type of clinical regulatory document (e.g., protocol, CSR, CIB, clinical sections of IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format. This position is for an independent, proactive, experienced medical writer with demonstrated leadership preparing multiple key summary submission documents (i.e., Clinical Summary of Safety, Clinical Summary of Efficacy, Clinical Overview) for the CTD who can guide others in these processes.

As an integral part of a clinical and/or study team, the position holder ensures the quality, compliance with internal and external standards, and timely and efficient production of English-language clinical documents using an electronic document management system. The position holder must contribute scientific knowledge, analytical skills, experience, independence, and insight to the analysis of data, the preparation of reports, and the production of registration dossiers.

Education and Experience:

  • Bachelor’s degree required (advanced degree preferred)

  • Substantial experience (8-10 years) as a Medical writer, or equivalent, and presenting relevant specialist qualifications (e.g., Ph.D. in life sciences)

  • Experience preparing clinical regulatory submission documents, including CTD Module 2 summaries

  • Accurate and detail-oriented with excellent inter-personal skills

  • Good understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology

  • Native English speaker or have proven excellent spoken and written English

  • Documented excellence in advanced features of Microsoft Word and ability to work effectively with a document management system

  • Ability to work both independently and collaboratively with a team in a cross-cultural, geographically dispersed environment

  • Demonstrated leadership, problem-solving ability, sense of urgency, and ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high-quality documents according to tight timelines

Please send resume to

Min Salary: $0.00

Max Salary: $0.00

State: MA