What are the responsibilities and job description for the Associate Director Medical Writer position at IQVIA, Inc.?
The Associate Director, 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. Mentors less experienced writers. Reports to a Director of Medical Writing or above.
Essential Functions of the Job (Key responsibilities)
- Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and Incyte authoring standards, as applicable, in adherence with study / project timelines and corporate objectives.
- Lead, manage, and coordinate all internal and external clinical medical writing activities associated with the preparation, compilation, and submission of applications to regulatory authorities globally for the assigned programs / compounds.
- 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.
- Lead or participate in cross-functional process improvement initiatives.
- Lead or participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents.
- Mentors more junior medical writing staff.
Qualifications (Minimal acceptable level of education, work experience, and competency)
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 proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https : / / jobs.iqvia.com / eoe
The potential base pay range for this role, when annualized, is $118,400.00 - $220,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and / or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and / or other forms of compensation may be offered, in addition to a range of health and welfare and / or other benefits.
Salary : $118,400 - $220,000
