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About the Role
Develops clinical documents for global regulatory submissions, providing strategic direction to cross-functional teams. Ensures timely delivery of high-quality, scientifically rigorous documents with accurate data presentation and interpretation.
Responsibilities
- Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and client's authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
- Manage medical writing projects, including developing timelines and communication with cross-functional team members to maintain awareness of review cycles and expectations.
- Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
- Review other documents associated with the assigned project(s), as appropriate.
- Participate in cross-functional process improvement initiatives.
- Participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents.
- Manage internal and contract medical writing resources as required to ensure timely completion of assigned projects.
Requirements
- At least 5 years of medical writing experience in the biopharmaceutical/CRO industry required or comparable experience within clinical or preclinical development.
- Proficiency in organizing and communicating clinical information required with minimal oversight.
- Strong organizational, time management, and project management skills are required.
- Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment.
- Proficient understanding and knowledge of global regulatory requirements needed and knowledge of therapeutic areas in all phases of clinical development desired.
Skills
- Medical writing
- Clinical document development
- Regulatory submissions
- Project management
- Communication
- Organization
- Time management
Experience Level
- Principal
Education Level
- Bachelor's degree required
- Advanced degree in a relevant scientific/clinical/regulatory field preferred
About the Company
- 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
Equal Opportunity
- IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud.
- All information and credentials submitted in your application must be truthful and complete.
- Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law.
- We appreciate your honesty and professionalism.