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Senior Specialist/Expert Medical Writer

0-2 years
Not Disclosed
10 Jan. 3, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Title: Senior Specialist/Expert Medical Writer
Location: Bangalore, India

About the Role:

As a Senior Specialist/Expert Medical Writer, you'll play a key role in supporting Medical Writing efforts for Marketed Products and Lifecycle Management, both globally and regionally. You will independently prepare critical clinical and regulatory documents, such as Protocols, Clinical Study Reports, and Investigator Brochures, while contributing to market approval submissions and line extensions.

Your responsibilities will also include:

  • Supporting the development and implementation of best practices in Medical Writing (MW).
  • Overseeing external writers, ensuring all documents meet company standards and regulatory requirements.
  • Ensuring timely production of documents while adhering to Standard Operating Procedures (SOPs).
  • Participating in meetings related to MW, quality control, and compliance activities.

Who You Are:

  • Qualifications: Graduate/Post-graduate degree in BPharm/MPharm, PhD, BDS, BSC/MSC, or equivalent job experience.
  • Experience: 4 to 9 years of regulatory medical writing experience.
  • Skills: Strong command of written and spoken English (including medical terminology) and knowledge of the AMA style guide.
  • Expertise: Familiarity with Clinical and Regulatory documents.

What We Offer:

  • A diverse and inclusive workplace where your unique perspective drives innovation.
  • Opportunities for career development and growth at your own pace.
  • A culture of belonging that supports both individual and collective success.
  • Competitive compensation and comprehensive benefits.

We are an Equal Opportunity Employer committed to creating an inclusive environment where everyone can thrive and make meaningful contributions.