Scientific Content Specialist
3 days ago
At VCLS, we are seeking a highly skilled Scientific Content Specialist to join our team.
About the Role:
We are looking for an experienced medical writer to lead client programs and ensure the highest quality of deliverables. The ideal candidate will have a strong understanding of ICH guidelines and regulatory requirements.
Key Responsibilities:
- Lead client programs as the primary medical writer, ensuring accurate and timely documents meet regulatory standards.
- 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 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.
- 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.
About You:
- You have a deep understanding of regulatory requirements and guidelines in medical writing.
- You are an excellent communicator with strong written and verbal skills.
- You possess attention to detail and can prioritize tasks effectively.
- You are proficient in MS Office and have experience working with reference management tools.
What We Offer:
- A competitive salary of $80,000 - $110,000 per year, depending on experience.
- A dynamic and collaborative work environment.
- The opportunity to work with a variety of clients and projects.
- Ongoing training and professional development opportunities.
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