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Pharmaceutical Regulatory Content Specialist

1 month ago


Bengaluru, Karnataka, India VCLS Full time

Compensation: $120,000 - $180,000 per year

About VCLS

VCLS 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 Description

The 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.
Required Skills and Qualifications

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.
Benefits

We offer a competitive compensation package, opportunities for professional growth, and a collaborative work environment.

Apply Now