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:

1. Act as the lead medical writer on client programs, ensuring the highest quality of deliverables.
2. Review draft and final documents prepared by VCLS consultants or clients, ensuring accuracy, consistency, and adherence to regulatory standards.
3. Draft and/or review clinical and regulatory documents, including study protocols, investigator brochures, clinical study reports, and clinical overviews.
4. Contribute to the writing of other regulatory documents, such as Orphan Drug Designation applications and Pediatric Investigation Plans.
5. Ensure that all documents comply with VCLS or client SOPs and style requirements.
6. Provide input into project scope and cost estimates.
7. Stay updated on relevant regulations and guidelines in medical writing.
8. Collaborate closely with cross-functional teams, including scientists, researchers, and regulatory affairs professionals.
9. Participate in client meetings and support business development activities as needed.

Minimum Requirements:

1. Minimum of 5+ years of experience as a Medical Writer in the pharmaceutical or biotech industry.
2. Bachelor's degree or higher in a scientific discipline.
3. Regulatory expertise.
4. CRO experience is preferable.
5. Strong understanding of ICH guidelines and regulatory requirements.
6. Experience with authoring clinical and regulatory documents, including study protocols, investigator brochures, and clinical study reports.
7. Excellent written and verbal communication skills.
8. Attention to detail and ability to prioritize tasks to meet deadlines.
9. Proficient in MS Office (Word, Excel, PowerPoint).
10. Ability to work independently and collaboratively within a team.
11. Knowledge of reference management and publication planning tools is a plus.