Associate Director, Principal Medical Writer
Wilmington, DE, USA | Incyte Corporation
Industry:Pharmaceutical / Biotech
Job Description:107 people have viewed this job
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 Principal Medical Writer develops clinical documents for submissions to regulatory authorities globally.The position works directly with multidisciplinary project team members with the goal of writing scientifically valid, complete, and consistent documents such as clinical study protocols and amendments, clinical study reports (CSRs), Investigator’s Brochures (IBs), clinical Module 2 summary documents, and other regulatory documents.The Principal Medical Writer oversees the medical writing activities of multiple compounds and will serve as lead writer on major submissions.
Essential Functions of the Job(Key responsibilities)
Lead, manage, and coordinate all internal and external writing activities associated with the preparation, compilation, and submission of applications to regulatory authorities globally.
Oversee and manage internal and contract medical writing resources as required to ensure timely completion of assigned projects.
Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and AMA Medical Writing styles, as applicable, in adherence with study/project timelines and corporate objectives.
Actively participate in study and/or project team meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
Administrate as appropriate, the receipt, collation, and incorporation of review comments needed for the completion of regulatory documents.
Lead or participate in defining and writing standard operating procedures and working practices which will allow the effective and efficient preparation of quality.
Lead or participate in cross-functional process improvement initiatives.
Mentor more junior medical writing staff.
Qualifications (Minimal acceptable level of education, work experience, and competency)
Bachelor's degree in a life science discipline, with Master's degree in life science discipline preferred.
At least 6 years writing experience in the biopharmaceutical/CRO industry required.
Proficient understanding and knowledge of domestic and international regulatory requirements required. and knowledge of therapeutic areas in all phases of clinical development desired.
Proficiency in organizing and communicating clinical information necessary.
Strong communications, organizational, time management, and project management skills are required.
Proficient in MS Word and experience with template systems (eg, StartingPoint).
Experience with an electronic document management system (eg, MasterControl, Documentum) and use of templates preferred.
Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment
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