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 advantageAbility to integrate, interpret, and summarize data from a variety of sources in a clear and concise mannerCompetence 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 supervisionGood understanding of common statistical methods used in clinical studies and interpretation of their resultsAbility to give a simple presentation to a project team and/or customer, e.g. on Medical Writing processesAbility to identifying consistencies and deficiencies in statistical output/sAbility to work on several projects at once while balancing multiple and overlapping timelinesDemonstrated abilities in collaboration with clients and internal stakeholdersKnowledge of regulations relevant to regulatory framework/sAbility to work with cross functional teamExperience in grooming /training junior writers and review their workExperience in leading small project team

Education & Experience:

Master’s 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 Years

IQVIA 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 https://jobs.iqvia.com