Senior Medical Writer

Role Overview: You will assist in writing, editing, and compiling written deliverables in the disciplines of chemistry, manufacturing, and controls (CMC), nonclinical, clinical, medical, and regulatory for submission to regulatory agencies at Allucent Regulatory Consulting. As an Associate Medical Writer, you will develop skills in scientific discussions related to the planning, production, and review of written deliverables. Additionally, you will be a member of the medical writing staff. Key Responsibilities: - Assist with writing, editing, and compiling written deliverables in various disciplines for submission to regulatory agencies, sponsor use, or for publication - Contribute to scientific discussions regarding the planning, production, and review of written deliverables - Develop knowledge of regulatory agency requirements, International Council on Harmonization (ICH) Guidelines, and industry best practices - Familiarize yourself with company templates, requirements, and resources for producing written deliverables - Aid in developing templates and guidelines for regulatory and other written deliverables - Perform literature searches when necessary Qualification Required: - Candidates with a B. S., M.S., Ph.D., Pharm. D., M.D., or equivalent degree in a scientific area strongly preferred - Minimum of 1 year of directly relevant work experience in drug, biologic, or device development post-degree, including some medical writing experience - Proficiency with computer applications such as Word, Excel, and PowerPoint - Good interpersonal, written, and verbal communication skills - Ability to work effectively in a matrix team environment - Familiarity with regulatory requirements and guidance, as well as applicable ICH Guidelines Additional Details: You will apply company policies and procedures to resolve various issues, contribute to the evaluation and improvement of processes within the Quality Management System, and maintain good communication with clients. Additionally, you may be involved in other areas of business as required. The office environment may involve lifting up to 25 pounds, with rare travel required. Note: The Allucent Talent Acquisition team manages the recruitment process, and unsolicited resumes will not obligate Allucent to future employment or remuneration.,