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Medical Writer

2+ years
Not Disclosed
10 April 25, 2025
Job Description
Job Type: Full Time Education: MD/PhD/PharmD 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

Medical Writer
Location: Bangalore, India, 5600664
Company: Teva Pharmaceuticals
Job ID: 61562
Date: April 23, 2025


About Teva Pharmaceuticals:
Teva Pharmaceuticals is on a mission to make good health more affordable and accessible, aiming to help millions around the world enjoy healthier lives. With a presence in nearly 60 countries, Teva is the world’s leading manufacturer of generic medicines and a proud producer of many products on the World Health Organization’s Essential Medicines List. Teva’s products reach at least 200 million people daily, and they are constantly seeking new ways to make a difference.


About This Role:
Teva Pharmaceuticals is seeking a Medical Writing Associate II in their Global Regulatory Medical Writing team. This individual will be responsible for writing and editing clinical regulatory documents used in drug development and product registration. The Medical Writer will primarily work at the project level and support the development of clinical research documentation for regulatory submissions.


Key Responsibilities:

  • Clinical Document Writing and Editing:

    • Write and edit clinical regulatory documents, including study reports, protocols, briefing books, and other submission documents (e.g., aggregate reports, post-authorization safety studies).

    • Compile, analyze, and summarize data from various sources.

    • Conduct proofreading, editing, document formatting, and comment resolution to ensure accuracy and completeness.

    • Ensure clear and consistent medical/scientific messaging in documents, adhering to applicable regulatory guidelines and departmental editorial standards.

  • Document Templates and SOPs:

    • Participate in the preparation and revision of document templates and Standard Operating Procedures (SOPs).

  • Training and Support:

    • Train and support other medical writers or external vendors/contractors in document planning, processes, and content development.


Qualifications:

  • Education:

    • Bachelor’s, Master’s, MD, PhD, PharmD in life sciences or a related field.

    • Minimum of 2+ years of relevant experience; an advanced degree is preferred.

  • Experience:

    • Experience writing clinical regulatory documents such as narratives, aggregate reports, and investigator brochures (IBs).

    • 2+ years of experience authoring protocols, clinical study reports, and submission documents.