Job Openings
Look through our list of current job openings below to find a career opportunity that is a match for you. If you find one that looks interesting, click on the job code to create an email. Be sure to put the job code for the position in which you are interested in the subject line, then attach your cover letter and resume as a Word document or pdf file and you’re set to send!
 Development |
| Associate Director/Director, Medical Writing
This position is responsible for the oversight, management and coordination of all medical writing activities. 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), Investigators Brochures (IBs) primarily, and select submission documents, Clinical Development Plans and other regulatory documents secondarily as workload permits. Actively participates in the process to ensure the timely submission of high quality, critical documentation both within and outside the company.
Responsibilities:
- Lead, manage and coordinate all internal and external writing activities associated with the preparation, compilation and submission of a planned NDA in early 2011
- Lead the work initiative to define and write standard operating procedures and working practices which will allow the effective and efficient preparation of quality documents in accordance with stated objectives and timelines
- Collaborate with Sr. Management to define the medical writing resources, job level and hiring plan needed to effectively manage the anticipated writing activities for the department
- Oversee and manage internal and contract medical writing resources as required
- Prepare regulatory documents for the ultimate purpose of submission to regulatory agencies, IRB/Ethics Committees and other relevant parties, in accordance with ICH and CFR guidelines, standards and processes and AMA Medical Writing styles, as applicable, in adherence with study/project timelines and objectives
- Actively participate in study and/or project team meetings to provide input regarding 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
Minimum Requirements:
- At least 8 years writing experience in the biopharmaceutical/CRO industry
- A Bachelor's degree in life science discipline with Master's degree in life science discipline preferred
- Prior management and/or supervisory experience in the biopharmaceutical/CRO industry
- Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality
- Proficient understanding and knowledge of domestic and international regulatory requirements required and knowledge of therapeutic areas in all phases of clinical development desired
- Electronic Document Management System (e.g., LiveLink, Documentum) skills
- Applies good judgment and demonstrates initiative to resolve issues
- Strong verbal, written and interpersonal communication skills needed to work effectively in a team environment
Job Code: TH6537PS 
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Incyte prefers to recruit candidates directly, rather than through a third party recruiter or agency. Incyte will only pay a fee for candidates submitted or presented where there is a signed recruiting agreement in place between Incyte and the recruiter or agency prior to the submittal and the candidate is submitted for a specific requisition. In the case of candidate(s) submitted or presented to Incyte by a recruiter or agency without a signed agreement, Incyte explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.
