Pharmaceutical Regulatory Content Specialist
5 days ago
Compensation: $120,000 - $180,000 per year
About VCLSVCLS is a reputable pharmaceutical company seeking an experienced Pharmaceutical Regulatory Content Specialist to join our team. Our organization is dedicated to delivering high-quality medical documents for various client projects.
Job DescriptionThe primary goal of this role is to deliver accurate and timely documents that meet regulatory standards and guidelines. Key responsibilities include:
- Drafting and reviewing clinical and regulatory documents, such as study protocols, investigator brochures, and clinical study reports.
- Acting as the lead content specialist on client programs, ensuring the highest quality of deliverables.
- Providing input into project scope and cost estimates.
- Staying updated on relevant regulations and guidelines in medical writing.
- Collaborating closely with cross-functional teams, including scientists, researchers, and regulatory affairs professionals.
To succeed in this role, you will need:
- A 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.
- Strong understanding of ICH guidelines and regulatory requirements.
- Excellent written and verbal communication skills.
- Attention to detail and ability to prioritize tasks to meet deadlines.
We offer a competitive compensation package, opportunities for professional growth, and a collaborative work environment.
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