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.