at Incyte Corporation in Wilmington, Delaware, United States
Job Description
Overview
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary(Primary function)
The Associate Director, Principal Medical Writer I Clinical Pharmacology & Pharmacometric (CPP) 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 CPP documents (eg, PK reports, PPK (population PK) and ER (exposure-response) reports, Integrated summary of immunogenicity, Summary of biopharmaceutics (module 2.7.1), and Summary of clinical pharmacology (module 2.7.2), Health authority responses) accurately and consistently present key data-driven CPP 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 CPP scientific and clinical development processes and global regulatory document standards. Mentors less experienced writers.Reports to VP, Head of CPP.
Essential Functions of the Job(Key responsibilities)
*Develop CPP related 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 CPP project timelines and corporate objectives.
*Manage medical writing projects, including developing timelines (working with the CPP/project teams, as necessary) and communication with CPP/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 CPP related regulatory documents.
*Review other documents associated with the assigned project(s) (eg, Pharmacometric 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.
*Mentor more junior medical writing staff.
Qualifications (Minimal acceptable level of education, work experience, and competency)
*Bachelor's degree required. Advanced degree in a relevant scientific/clinical/regulatory field preferred including CPP background.
*At least 5 -7 years of medical writing experience in the biopharmaceutical/CRO industry required or comparable experience within clinical development.
*Proficiency in organizing and communicating CPP 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
*Proficient in MS Word. Experience with an electronic document management system and templates is required.
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.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
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Job Posting:
1237410
Posted On:
Feb 07, 2024
Updated On:
Mar 01, 2024
