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Associate Director, Principal Medical Writing II
vor 5 Stunden
Overview
Job Summary (Primary function)
The Associate Director, Principal Medical Writer II 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)
- Lead or participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents. Provides guidance and support to less experienced medical writing staff.
- Lead or participate in cross-functional process improvement initiatives.
- Review other documents associated with the assigned project(s) (eg, Protocols and Statistical Analysis Plans), as appropriate.
- Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
- 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.
- 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.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- Strong communication skills, including verbal, written, and interpersonal, needed to work effectively in a team environment.
- Excellent project management skills including in depth understanding of clinical timelines (study and submission level) and working knowledge of roles of other functional areas and the interdependencies among groups.
- Demonstrated ability to understand and interpret clinical and scientific data with minimal oversight; ability to define data presentation to meet key messages developed by the clinical team.
- Significant experience in medical writing within the biopharmaceutical/CRO industry or comparable experience in clinical or preclinical development is required.
- Bachelor's degree or equivalent experience required. Advanced degree in a relevant scientific/clinical/regulatory field preferred.
- Ability to interact effectively with colleagues and leaders at all levels within Incyte, proactively facilitating effective information exchange and communication, including problem-solving and issue resolution.
- Proficient in MS Word or similar word processing software. Experience with an electronic document management system and templates is preferred.
- Demonstrated ability to independently lead the development, review, and approval of clinical documents and the ability to identify any new or unique document types that may require a different approach.
- Proficient understanding and knowledge of global regulatory requirements is needed, and familiarity with therapeutic areas in various phases of clinical development is desired.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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