Senior Medical Writer

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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.

Requirements

• 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
• eCTD
• 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.