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

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