Job Description

IQVIA is looking for candidates who have expertise in regulatory writing to join our Real World Evidence team. The Ideal candidate will have 5-12 years of experience working as Regulatory Medical Writer, adept in developing and authoring clinical study protocols, informed consent documents, clinical study reports.Expectations:

• Familiarity with the structural and content requirements of clinical study reports, clinical study protocols, and similar documents (not safety documents like PADERs, PBRERs etc. or clinical or non-clinical overviews at the moment); experience on real world studies will be an added advantage
• Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner
• Competence in completing a good first draft clinical study report or a clinical study protocol in a routine therapeutic area within are reasonable timeframe with limited guidance and/or supervision
• Good understanding of common statistical methods used in clinical studies and interpretation of their results
• Ability to give a simple presentation to a project team and/or customer, e.g. on Medical Writing processes
• Ability to identifying consistencies and deficiencies in statistical output/s
• Ability to work on several projects at once while balancing multiple and overlapping timelines
• Demonstrated abilities in collaboration with clients and internal stakeholders
• Knowledge of regulations relevant to regulatory framework/s
• Ability to work with cross functional team
• Experience in grooming /training junior writers and review their work
• Experience in leading small project team

Education & Experience:Masters degree or PhD in the field of healthcare (e.g. Bio-medical sciences/ life sciences/ Pharmacy/ Bio-Tech, MBA in Pharmaceutical Management etc.)Experience 8 to 12 YearsIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at