What are the responsibilities and job description for the Associate Director Medical Writer Job at IQVIA in Durham position at IQVIA?
IQVIA Associate Director Medical Writer - Durham, North Carolina
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 (e.g., 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.
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 processes needed for the completion of regulatory documents.
- Review other documents associated with the assigned project(s) (e.g., 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.
- Mentor more junior medical writing staff.
Qualifications :
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.
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).
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Salary : $118,400 - $220,000
