Instagram
youtube
Facebook

Comw-0 Principal Medical Writer

10+ years
Not Disclosed
10 Feb. 4, 2025
Job Description
Job Type: Full Time Education: BPharm/MPharm/PHD/BDS/BSC/MSC/ MD/PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Principal Medical Writer – Bangalore, India (principal-medical-writer-bangalore)

Job ID: 282829
Location: Bangalore, Karnataka, India
Job Type: Full-time

About the Role:

As a Principal Medical Writer, you will take a leadership role in medical writing for Marketed Products and Lifecycle Management at both global and regional levels. You will be responsible for independently preparing and overseeing the development of critical clinical and regulatory documents, ensuring compliance with regulatory requirements and company standards.

Key Responsibilities:

  • Lead medical writing efforts for marketed products and lifecycle management.
  • Independently prepare clinical and regulatory documents, including Protocols, Clinical Study Reports, Investigator Brochures, and Clinical Summary documents.
  • Support submissions for market approval and line extensions with minimal supervision.
  • Oversee and coordinate external writers, ensuring clarity, consistency, and adherence to quality standards.
  • Serve as a subject-matter expert in clinical study teams, leading document-related discussions and reviewing study-related documents.
  • Ensure all documents comply with agreed timelines, SOPs, regulatory requirements, and company guidelines.
  • Contribute to best practices and process improvements within Medical Writing.

Who You Are:

  • Graduate/Postgraduate degree in BPharm/MPharm, PhD, BDS, BSc/MSc, or equivalent with extensive medical writing expertise.
  • 10+ years of experience in the pharmaceutical industry, including 5–8 years in regulatory medical writing (postmarketing studies experience preferred).
  • Excellent English writing and speaking skills, including medical terminology.
  • Familiarity with the AMA style guide and regulatory documentation standards.

Why Join Us?

At our organization, we celebrate diversity and believe in fostering innovation through a culture of inclusion and belonging. We offer opportunities for personal and professional growth, empowering our team to lead in science and technology while making a meaningful impact on millions of lives.

Apply Now!

Be part of a dynamic and diverse team where you can work your magic and champion human progress!