Senior Medical Writer/Medical Writer

Senior Medical Writer/Medical Writer VCLS is seeking a highly skilled Senior Medical Writer/Medical Writer to join our team. In this role, you will be responsible for authoring high-quality medical documents for various client projects, including drugs, biologics, and Advanced Therapy Medicinal Products (Cell-, Gene- and Tissue therapies). Your primary goal will be to deliver accurate and timely documents that meet regulatory standards and guidelines. Responsibilities: • Act as the lead medical writer on client programs, ensuring the highest quality of deliverables. • Review draft and final documents prepared by VCLS consultants or clients, ensuring accuracy, consistency, and adherence to regulatory standards. • Draft and/or review clinical and regulatory documents, including study protocols, investigator brochures, clinical study reports, and clinical overviews. • Contribute to the writing of other regulatory documents, such as Orphan Drug Designation applications and Pediatric... Investigation Plans. • Ensure that all documents comply with VCLS or client SOPs and style requirements. • Provide input into project scope and cost estimates. • Stay updated on relevant regulations and guidelines in medical writing. • Collaborate closely with cross-functional teams, including scientists, researchers, and regulatory affairs professionals. • Participate in client meetings and support business development activities as needed. • Minimum of 5+ years of experience as a Medical Writer in the pharmaceutical or biotech industry. • Bachelor's degree or higher in a scientific discipline. • Regulatory expertise • CRO experience is preferable • Strong understanding of ICH guidelines and regulatory requirements. • Experience with authoring clinical and regulatory documents, including study protocols, investigator brochures, and clinical study reports. • Excellent written and verbal communication skills. • Attention to detail and ability to prioritize tasks to meet deadlines. • Proficient in MS Office (Word, Excel, PowerPoint). • Ability to work independently and collaboratively within a team. • Knowledge of reference management and publication planning tools is a plus Apply Job!