Astrazeneca

Actively Hiring

Medical Writer

Bangalore, India

Full time

Role Overview

The role holders provide strategic leadership and communications expertise to clinical drug programs, authoring clinical-regulatory documents and providing critical review to achieve high-quality standards.

About Astrazeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines targeting some of the planet's most serious diseases.

Key Responsibilities

Independently manage clinical regulatory writing across a complex portfolio
Serve as lead author for the most complex clinical-regulatory documents in a program
Drive the clinical Submission Communication Strategy (cSCS) when acting as submission lead
Provide strategic communications leadership as part of clinical delivery and submission teams
Partner closely with clinical, biostatistics, regulatory, safety, and operations teams
Lead internal and external authoring teams, including vendor medical writers
Operate proactively at the program level, shaping clinical narratives across studies
Support the development of Clinical Regulatory Writing Managers

Requirements & Eligibility

Life Sciences degree in an appropriate subject area
Minimum 10+ years of significant medical writing experience in the pharmaceutical industry or CRO
Ability to advise and lead communication projects
Understand drug development and communication process from development, launch through life cycle management
In depth knowledge of the technical and regulatory requirements related to the role

Required Skills & Tech

Medical WritingRegulatory RequirementsClinical DevelopmentLife SciencesPortfolio Management