Principal Medical Writer is responsible for the development of clinical documents for submissions to regulatory authorities globally. Provides strategic direction to cross-functional project teams with minimal oversight to ensure that clinical documents (eg, Investigators' Brochures [IBs], Clinical Study Reports [CSRs], and marketing authorization submission documents) accurately and consistently present key data-driven clinical messages in accordance with program goals and regulatory requirements. Writes or provides direction and leadership to other writers to ensure the timely delivery of high quality documents that are scientifically rigorous, logically organized, and have accurate data presentation and interpretation. Oversees the medical writing activities of multiple compounds and serves as lead writer for individual summary documents. Has a broad understanding of clinical research processes and global regulatory document standards.
Essential Functions
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 (working with the study/project teams, as necessary) 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) (eg, Protocols and Statistical Analysis Plans), 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.
Qualifications
Bachelor's degree required. Advanced degree in a relevant scientific/clinical/regulatory field preferred.
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.
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
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.