at Incyte Corporation in Wilmington, Delaware, United States
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)
This position works cross-functionally to manage the end-to-end review process for Incyte's advertising and promotional review process. This position will be responsible for serving as a strategic business partner and liaison across functional stakeholders (e.g. Commercial, Regulatory, Legal, and Medical.) This includes the daily involvement in managing the Medical, Legal and Regulatory (MLR) review process, in addition to the production, distribution, eCTD/OPDP submission, and retirement of materials. The position plays a key role in managing other key projects in Marketing Operations. The position will report to the Senior Director of Marketing Operations.
Essential Functions of the Job (Key responsibilities)
Lead and manage cross-functional promotional review (MLR) meetings
Build and manage meeting agendas
Facilitate meetings while scribing MLR Reviewer comments and job requirements
Steer productive meeting discussions
Manage all meeting logistics
Manage all aspects of the end-to-end review process for offline and live reviews to help achieve deadlines including reviewing Reviewer and Project Owner comments to determine the appropriate course of action.
Attend key brand/agency meetings to ensure awareness of the product strategies and initiatives
Gather insight on print/digital production timing for planning purposes
Route/oversee routing of jobs throughout the review cycle and provide necessary internal and external partner follow-up
Ensure the appropriate proofreading/editorial review is conducted pre-MLR and post-MLR review
Manage all aspects of the processes for proofing, distribution, and dissemination, including eCTD requirements
Manage web-based PI ordering system and orders
Liaison with Warehouse vendor bi-weekly to review web-based sales force material ordering system, inventory levels and any necessary system enhancements
Monitor promotional materials that have a value that requires reporting (per compliance regulations) and work with current guidelines and process for the tracking of costs
Ensure the electronic file for delivery of OPDP compliance submission information to Regulatory meets all eCTD guidelines from the FDA
Support reporting needs to track/identify materials requiring eCTD submission
Provide monthly MLR metrics and analysis of data
Provide support to Senior Director of Marketing Operations as requested
Qualifications (Minimal acceptable level of education, work experience, and competency)
Bachelor's degree required.
4-8 years' work experience preferably in a Marketing Operations role in the pharmaceutical/biotechnology industries or within an advertising agency (focus on pharmaceutical/biotechnology).
Proficient with electronic review technology platform.
Ability to manage multiple projects and processes within a growing organization.
Ability to remain flexible and adapt to a changing environment.
Ability to successfully work across functions.
Solid understanding of legal/medical/regulatory compliance and promotional review guidelines.
Strong communication skills and strategic thinking.
Strong ability to demonstrate attention to detail.
Ability to effectively lead and influence others without management authority.
Ability to manage MLR participants of varying levels and steer productive meeting discussions.
Microsoft Office skills (Outlook, Excel, PPT, Word).
Oncology and/or Dermatology pharmaceutical experience a plus.
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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